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Updated 3 minutes ago · U.S. FDA

Medicines recalls

Prescription and over-the-counter medicines, recalled for contamination, wrong strength, impurities or bad labels. New recalls appear here every day, explained in plain English.

Counts are for the last 30 days.

In the last 30 days the FDA announced 67 medicines recalls. Over the last 90 days the most common cause was manufacturing quality (cgmp) (35 recalls). 9 of the 138 FDA recalls in that period were Class I, the most serious kind.

New Medicines recalls per weekLast 8 weeks

403020100

Sep 14

Sep 21

Sep 28

Oct 5

Oct 12

Oct 19

Oct 26

Nov 2

Show as table

Week of	Medicines
Sep 14	6
Sep 21	10
Sep 28	14
Oct 5	8
Oct 12	34
Oct 19	5
Oct 26	28
Nov 2	0

Why products were recalledLast 90 days, grouped from the official recall reasons

Manufacturing quality (cGMP)35 recalls

Wrong strength, impurity or failed test34 recalls

Not sterile31 recalls

Contamination (mold, bacteria, other)19 recalls

Labeling or packaging error2 recalls

Foreign object (metal, plastic, glass)2 recalls

Device fault or failure2 recalls

Other14 recalls

Show as table

Item	Value (recalls)
Manufacturing quality (cGMP)	35
Wrong strength, impurity or failed test	34
Not sterile	31
Contamination (mold, bacteria, other)	19
Labeling or packaging error	2
Foreign object (metal, plastic, glass)	2
Device fault or failure	2
Other	14

How serious were the FDA recalls?Last 90 days

86%

Class I — most serious · 9Class II · 118Class III — least serious · 11

Show as table

Part	Count	Share
Class I — most serious	9	7%
Class II	118	86%
Class III — least serious	11	8%

Class I: Most serious: using the product could cause serious injury or death. Class II: May cause temporary or reversible health problems; serious harm is unlikely. Class III: Unlikely to cause harm, but breaks FDA rules (for example a labeling error).

Latest medicines recalls

Medicines · Oct 28, 2026 · Class II · Ongoing

Brush Buddies, Cookies 'n Cream Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

Brush Buddies, Cookies 'n Cream Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-519-35, Item # 88519, UPC 8 10147 88519 0

Quantity: 112,092 tubes

Distribution: US Nationwide.

Recall number D-0063-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Brush Buddies, Whitening Anti-cavity Fluoride Toothpaste, with Baking Soda, (sodium monofluorophosphate 0.76%) Cool Mint, Net Wt

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

Brush Buddies, Whitening Anti-cavity Fluoride Toothpaste, with Baking Soda, (sodium monofluorophosphate 0.76%) Cool Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-007-07, ITEM # 999131, 8 50010 84249 3

Quantity: 797,868 tubes

Distribution: US Nationwide.

Recall number D-0065-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations

Product details, where it was sold and what to do

Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-003-40, Item # 32731, UPC 8 50048 32731 3

Quantity: 320,232 tubes

Distribution: US Nationwide.

Recall number D-0055-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle

Pfizer · Manhattan, NY, United States

Why: Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.

Product details, where it was sold and what to do

Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-10

Quantity: 134 1000-count bottles

Distribution: US Nationwide and Puerto Rico

Recall number D-0051-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Testosterone Cypionate, 200 mg/mL, packaged in a) 5 mL vials (NDC 73271-1225-1) and b) 30 m vials (

Right Value Drug Stores LLC · Irving, TX, United States

Why: Lack of sterility assurance.

Product details, where it was sold and what to do

Testosterone Cypionate, 200 mg/mL, packaged in a) 5 mL vials (NDC 73271-1225-1) and b) 30 m vials ( NDC 73271-1226-2) This Is A Compounded Dug, Intramuscular Use, Office Use Only, 8400 Esters Blvd, STE 190, Irving, TX 75063.

Quantity: 4675 vials

Distribution: Nationwide in the USA.

Recall number D-0070-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Brush Buddies, Barbie, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations

Product details, where it was sold and what to do

Brush Buddies, Barbie, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-001-40, Item# 88022, UPC 8 10147 88022 5

Quantity: 409,800 tubes

Distribution: US Nationwide.

Recall number D-0053-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Brush Buddies, Vanilla Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations

Product details, where it was sold and what to do

Brush Buddies, Vanilla Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-517-35, Item # 88517, UPC 8 10147 88517 6

Quantity: 112,092 tubes

Distribution: US Nationwide.

Recall number D-0061-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios I…

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-785-35, Item # 88785, UPC 8 10147 88785

Quantity: 15,264 tubes

Distribution: US Nationwide.

Recall number D-0069-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets

Ascend Laboratories, LLC · Bedminster, NJ, United States

Why: Out of specification due to dissolution.

Product details, where it was sold and what to do

Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-502-30.

Quantity: 11,424 bottles.

Distribution: Nationwide within the United States

Recall number D-0045-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Evo, Advanced Whitening, Anticavity Fluoride Toothpaste, (sodium fluoride 0.24%) Peppermint, Net Wt

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

evo, Advanced Whitening, Anticavity Fluoride Toothpaste, (sodium fluoride 0.24%) Peppermint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-886-19, Item# 88619, UPC 8 10147 88619 7

Quantity: 405,336 tubes

Distribution: US Nationwide.

Recall number D-0059-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle

Pfizer · Manhattan, NY, United States

Why: Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.

Product details, where it was sold and what to do

Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-01.

Quantity: 15,815 100-count bottles

Distribution: US Nationwide and Puerto Rico

Recall number D-0052-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Brush Buddies, Chocolate Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

Brush Buddies, Chocolate Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-518-35, Item # 88518, UPC 8 10147 88518 3

Quantity: 112,092 tubes

Distribution: US Nationwide.

Recall number D-0064-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class I · Ongoing

Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial

Par Health USA, LLC · Rochester, MI, United States

Why: Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.

Product details, where it was sold and what to do

Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Cranbury, NJ 08512, NDC 42023-182-89.

Quantity: 1944 vials

Distribution: Nationwide within the United States

Recall number D-0083-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class I · Ongoing

Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water), 200 mg/mL, 10 mL multi-dose vial

Greenwich Rx · Tomball, TX, United States

Why: Microbial Contamination of Sterile Products

Product details, where it was sold and what to do

Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water), 200 mg/mL, 10 mL multi-dose vial, Rx only, Subcutaneous Only, Greenwich Rx.

Quantity: 4,319 vials

Distribution: US Nationwide in th USA

Recall number D-0084-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class III · Ongoing

Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle

Viatris, Inc. · Morgantown, WV, United States

Why: Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications

Product details, where it was sold and what to do

Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India, NDC 0378-1075-93.

Quantity: 21,620 30-count bottles

Distribution: Nationwide in the USA.

Recall number D-0049-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0.45%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc…

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0.45%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-786-35, Item # 88786 UPC 8 10147 88786 6

Quantity: 15,264 tubes

Distribution: US Nationwide.

Recall number D-0068-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Brush Buddies, Crayola Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

Brush Buddies, Crayola Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-005-40, Item # 32732, UPC 8 50048 32732 0

Quantity: 320,232 tubes

Distribution: US Nationwide.

Recall number D-0057-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton, Distributed by: Hepalink USA Inc., Langhome, …

Shenzhen Techdow Pharmaceutical Co., Ltd. · Shenzhen, China

Why: Lack of Assurance of Sterility

Product details, where it was sold and what to do

Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton, Distributed by: Hepalink USA Inc., Langhome, PA 19047-1885. Carton NDC: NDC 81952-111-06, Vial NDC: 81942-111-01

Quantity: 251,000 1 mL multidose vials

Distribution: Nationwide in the USA.

Recall number D-0050-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles

Hikma Pharmaceuticals USA INC. · Columbus, OH, United States

Why: Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.

Product details, where it was sold and what to do

Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights, NJ 07922 USA by: Arab Pharmaceuticals Manufacturing PSC PO Box 41, Sahab-Jordon, NDC 82249-011-12.

Quantity: 2136 bottles

Distribution: Nationwide within the United States

Recall number D-0076-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Brush Buddies, Hot Wheels, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

Brush Buddies, Hot Wheels, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-002-40, Item # 88047, UPC 8 10147 88047 8

Quantity: 411,600 tubes

Distribution: US Nationwide.

Recall number D-0054-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Cinacalcet Tablets, 30 mg, 30-count bottle

STRIDES PHARMA INC · Bridgewater, NJ, United States

Why: Failed dissolution specifications

Product details, where it was sold and what to do

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, 605 014, India; Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807, NDC 64380-883-04

Quantity: 49,488 30-count bottles

Distribution: US Nationwide

Recall number D-0079-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

BB (Brush Buddies) Cavity Protection, Anti-Cavity Fluoride Toothpaste, (sodium monofluorophosphate 0.76%) Cool Mint, 2 Value Pack, Two 3.5 …

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

BB (Brush Buddies) Cavity Protection, Anti-Cavity Fluoride Toothpaste, (sodium monofluorophosphate 0.76%) Cool Mint, 2 Value Pack, Two 3.5 oz (99g) tubes, Total Net Wt 7 oz (198g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-035-10, Item # 88543, UPC 8 10147 88543 5

Quantity: 231,936 tubes

Distribution: US Nationwide.

Recall number D-0066-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Brush Buddies, My Little Pony Scents Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

Brush Buddies, My Little Pony Scents Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-008-40, Item# 88270, UPC 8 10147 88270 0.

Quantity: 17,400 tupes

Distribution: US Nationwide.

Recall number D-0058-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0,24%) Peppermint, Net Wt 3.5 oz (99g), Distribute…

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0,24%) Peppermint, Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-885-42, Item # 88542, UPC 8 10147 88542 8

Quantity: 198,288 tubes

Distribution: US Nationwide.

Recall number D-0067-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride0.243%) Watermelon Flavor, Net Wt

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride0.243%) Watermelon Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-004-40, Item # Product code: 32730, UPC 8 50048 32730 6.

Quantity: 320,232 tubes

Distribution: US Nationwide.

Recall number D-0056-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-620-35, Item # 88620 UPC8 10147 88620 3

Quantity: 389,880 tubes

Distribution: US Nationwide.

Recall number D-0060-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class I · Ongoing

Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial

Par Health USA, LLC · Rochester, MI, United States

Why: Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.

Product details, where it was sold and what to do

Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 42023-182-01.

Quantity: 18,991 vials

Distribution: Nationwide within the United States

Recall number D-0082-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 28, 2026 · Class II · Ongoing

Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt

PRITAM INTERNATIONAL PRIVATE LIMITED · Haridwar, India

Why: CGMP Deviations.

Product details, where it was sold and what to do

Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-520-35, Item # 88520, UPC 8 10147 88520 6

Quantity: 112,092 tubes

Distribution: US Nationwide.

Recall number D-0062-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 21, 2026 · Class II · Ongoing

Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL

Houston Rx LLC · Houston, TX, United States

Why: Lack of assurance of sterility.

Product details, where it was sold and what to do

Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.

Quantity: 64 vials

Distribution: Nationwide in the USA.

Recall number D-0040-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

Medicines · Oct 21, 2026 · Class II · Ongoing

Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial

Zydus Pharmaceuticals (USA) Inc · Pennington, NJ, United States

Why: Failed Impurities/Degradation Specifications.

Product details, where it was sold and what to do

Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1907-1.

Quantity: 70776 vials

Distribution: Nationwide within the United States

Recall number D-0039-2027 in the FDA Enforcement Report. Check the lot numbers and dates on your product against the description above.

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What to do if you own a recalled product

Match it exactly. Recalls usually cover specific lot or batch numbers, "best by" dates, model numbers or sizes. Compare every detail on your product with the notice.
Stop using it. For food and medicine, do not eat, take or give it to pets, even if it looks and smells fine: Listeria and Salmonella do not change how food looks.
Follow the remedy. Most recalls offer a refund, repair or replacement. Return food to the store or follow the company's instructions; for products, contact the company named in the notice.
Do not stop a prescription medicine on your own. Ask your pharmacist or doctor first. They can swap you to an unaffected batch.
Report problems. In the U.S., report illnesses from food or medicine to FDA MedWatch and injuries from products to SaferProducts.gov.

Beware of recall scams

Criminals send fake "recall refund" texts and emails that ask you to pay a "shipping fee" or enter card details. Real recalls never ask for payment. Paste any suspicious recall message into our scam text checker. Read more: Product recalls: how they work and what to do.

Sources: U.S. Food and Drug Administration Enforcement Reports (via openFDA) and the U.S. Consumer Product Safety Commission recall database. FDA enforcement reports list recalls when they are classified, which can be a few weeks after the company's first announcement. Vehicle recalls are available per vehicle in our VIN check.