Drug recalls
Drug recall enforcement reports: the product, the firm, the reason and the recall class. 18,110 records; openFDA updated it 2026-11-10. About this dataset
Newest records
- Class II14,632
- Class I1,753
- Class III1,723
- Not Yet Classified2
- Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed b…
Ascend Laboratories, LLC · Out of specification due to dissolution.
- 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 · CGMP Deviations.
- Brush Buddies, Vanilla Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distri…
PRITAM INTERNATIONAL PRIVATE LIMITED · CGMP Deviations
- Brush Buddies, Barbie, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by As…
PRITAM INTERNATIONAL PRIVATE LIMITED · CGMP Deviations
- 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…
Right Value Drug Stores LLC · Lack of sterility assurance.
- Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017,…
Pfizer · Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
- Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Di…
PRITAM INTERNATIONAL PRIVATE LIMITED · CGMP Deviations
- Brush Buddies, Whitening Anti-cavity Fluoride Toothpaste, with Baking Soda, (sodium monofluorophosphate 0.76%) Cool Mint, Net Wt. 3.5 oz (9…
PRITAM INTERNATIONAL PRIVATE LIMITED · CGMP Deviations.
- Brush Buddies, Cookies 'n Cream Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g…
PRITAM INTERNATIONAL PRIVATE LIMITED · CGMP Deviations.
- Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.
Houston Rx LLC · Lack of process control
- Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054.…
Teva Pharmaceuticals USA, Inc · Presence of Foreign Tablets/Capsules
- Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Car…
American Health Packaging · Presence of Foreign Tablets/Capsules
- Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 39151…
Zydus Pharmaceuticals (USA) Inc · Failed Impurities/Degradation Specifications.
- 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 77…
Houston Rx LLC · Lack of assurance of sterility.
- Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.…
K.C. Pharmaceuticals, Inc. · Lack of Assurance of Sterility
- QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific pat…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific p…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
- Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific…
Carolina Infusion, LLC · Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.