Chapter 01 — Drugs recalls

Drugs recalls, as they break.

FDA drug enforcement recalls — contamination, potency, packaging defects.

Updated 2026-11-05 · 300 recalls tracked

Chapter 02 — Drugs recalls

The current drugs recall list.

38 recalls in Drugs

Drugs FDA

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

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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 Singl

Brand: Par Health Usa, Llc

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

What to do: Class I recall (Ongoing). Stop using / discard the affected lot; contact Par Health Usa, Llc.

Drugs FDA

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

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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, N

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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 8414

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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, N

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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 Asht

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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 64380-883-0

Brand: Strides Pharma Inc

Hazard: Failed dissolution specifications

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Strides Pharma Inc.

Drugs FDA

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 84140-0

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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 Bo

Brand: Hikma Pharmaceuticals Usa Inc.

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

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Hikma Pharmaceuticals Usa Inc..

Drugs FDA

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

Brand: Shenzhen Techdow Pharmaceutical Co., Ltd.

Hazard: Lack of Assurance of Sterility

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Shenzhen Techdow Pharmaceutical Co., Ltd..

Drugs FDA

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, N

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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.

Brand: Viatris, Inc.

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

What to do: Class III recall (Ongoing). Stop using / discard the affected lot; contact Viatris, Inc..

Drugs FDA

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

Brand: Greenwich Rx

Hazard: Microbial Contamination of Sterile Products

What to do: Class I recall (Ongoing). Stop using / discard the affected lot; contact Greenwich Rx.

Drugs FDA

Amitriptyline Hydrochloride, Tablets, USP, 10 mg, 5 x 10 Unit dose cards in paper cartons, Rx only, Manufactured for AvKARE, Pulaski, TN 38478, NDC 50268-037-15.

Brand: Avkare

Hazard: Failed dissolution specifications.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Avkare.

Drugs FDA

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, ND

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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.

Brand: Pfizer

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

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pfizer.

Drugs FDA

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

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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-

Brand: Ascend Laboratories, Llc

Hazard: Out of specification due to dissolution.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Ascend Laboratories, Llc.

Drugs FDA

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 # 8878

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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

Brand: Pritam International Private Limited

Hazard: CGMP Deviations

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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 84140-001-4

Brand: Pritam International Private Limited

Hazard: CGMP Deviations

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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, ST

Brand: Right Value Drug Stores Llc

Hazard: Lack of sterility assurance.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Right Value Drug Stores Llc.

Drugs FDA

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

Brand: Pfizer

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

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pfizer.

Drugs FDA

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

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

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 91

Brand: Pritam International Private Limited

Hazard: CGMP Deviations.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Pritam International Private Limited.

Drugs FDA

Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.

Brand: Houston Rx Llc

Hazard: Lack of process control

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Houston Rx Llc.

Drugs FDA

Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05

Brand: Teva Pharmaceuticals Usa, Inc

Hazard: Presence of Foreign Tablets/Capsules

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Teva Pharmaceuticals Usa, Inc.

Drugs FDA

Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-620-01; NDC Unit Dose: 60687-620-11

Brand: American Health Packaging

Hazard: Presence of Foreign Tablets/Capsules

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact American Health Packaging.

Drugs FDA

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., Pe

Brand: Zydus Pharmaceuticals (Usa) Inc

Hazard: Failed Impurities/Degradation Specifications.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Zydus Pharmaceuticals (Usa) Inc.

Drugs FDA

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.

Brand: Houston Rx Llc

Hazard: Lack of assurance of sterility.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Houston Rx Llc.

Drugs FDA

Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile Tears, Distributed by: Cr

Brand: K.C. Pharmaceuticals, Inc.

Hazard: Lack of Assurance of Sterility

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact K.C. Pharmaceuticals, Inc..

Drugs FDA

QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road,

Brand: Carolina Infusion, Llc

Hazard: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Carolina Infusion, Llc.

Drugs FDA

TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Roa

Brand: Carolina Infusion, Llc

Hazard: Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Carolina Infusion, Llc.

Drugs FDA

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek R

Brand: Carolina Infusion, Llc

Hazard: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Carolina Infusion, Llc.

Drugs FDA

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek R

Brand: Carolina Infusion, Llc

Hazard: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Carolina Infusion, Llc.

Drugs FDA

Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Ro

Brand: Carolina Infusion, Llc

Hazard: Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

What to do: Class II recall (Ongoing). Stop using / discard the affected lot; contact Carolina Infusion, Llc.

Chapter 03 — Personalised alerts

We watch the feeds. You get the email.

Pick your categories. We email you a digest whenever a new matching recall drops. Free, unsubscribe anytime.

Chapter 04 — For developers & compliance teams

A recall API: one JSON feed across CPSC, FDA, NHTSA & USDA.

The government recall APIs are fragmented — different formats, IDs, date conventions, and NHTSA has no bulk feed at all. Recall Alert exposes the unified cross-agency schema they don't offer: one GET /api/recalls endpoint returning normalized JSON (agency, category, brand, hazard, date, remedy). Built for product-liability law, insuretech underwriting and compliance monitoring.

Keywords we serve: recall API JSON · CPSC FDA NHTSA combined feed · product recall API · unified recall data feed.

Chapter 05 — Good to know

Frequently asked questions.

Where does this recall data come from?

Live government feeds: the FDA openFDA enforcement API (food, drugs, medical devices), the NHTSA vehicle recalls API, and the CPSC SaferProducts API for consumer and children’s products. We normalize them into one list and refresh every 6 hours.

Is this the official recall source?

No. We aggregate and link to the official agency notice for each recall. Always confirm details and remedies on the linked FDA, NHTSA, or CPSC page before acting.

How do I get alerts for my products?

Enter your email and pick the categories you care about. When a new matching recall appears, you get an email digest. Unsubscribe anytime.

How often is the list updated?

Every 6 hours via an automated job. The "Updated" timestamp at the top of the page shows the last successful refresh.

Is it free?

Yes. The recall feed and email alerts are free. We may earn a commission on replacement-product links, which helps keep it running.