Browse Drug Recalls

633 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 633 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 633 FDA drug recalls in 2026.

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DateProductReasonClassFirm
Oct 13, 2026 Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose V... Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene terapha... Class I Par Health USA, LLC
Oct 13, 2026 Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose V... Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene terapha... Class I Par Health USA, LLC
Oct 9, 2026 Testosterone Cypionate, 200 mg/mL, packaged in a) 5 mL vials (NDC 73271-1225-... Lack of sterility assurance. Class II Right Value Drug Stores LLC
Oct 7, 2026 Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides... Failed dissolution specifications Class II STRIDES PHARMA INC
Oct 6, 2026 Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, ... Out of specification due to dissolution. Class II Ascend Laboratories, LLC
Oct 6, 2026 Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distribute... Presence of Foreign Tablets/Capsules Class II American Health Packaging
Oct 6, 2026 Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx on... Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity. Class II Hikma Pharmaceuticals USA INC.
Oct 1, 2026 Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacter... Microbial Contamination of Sterile Products Class I Greenwich Rx
Oct 1, 2026 Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx On... Failed Impurities/Degradation Specifications. Class II Zydus Pharmaceuticals (USA) Inc
Oct 1, 2026 Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only... Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications Class III Viatris, Inc.
Oct 1, 2026 Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 v... Lack of Assurance of Sterility Class II Shenzhen Techdow Pharmaceutical Co., Ltd.
Sep 29, 2026 Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 1000-count bot... Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing. Class II Pfizer
Sep 29, 2026 Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bot... Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing. Class II Pfizer
Sep 29, 2026 Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, ... Presence of Foreign Tablets/Capsules Class II Teva Pharmaceuticals USA, Inc
Sep 28, 2026 Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, R... Failed Content Uniformity Specifications Class II Preferred Pharmaceuticals, Inc.
Sep 25, 2026 Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, H... Lack of assurance of sterility. Class II Houston Rx LLC
Sep 25, 2026 Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Housto... Lack of process control Class II Houston Rx LLC
Sep 25, 2026 Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals I... Failed Impurities/Degradation Specifications Class III SUN PHARMACEUTICAL INDUSTRIES INC
Sep 25, 2026 Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc.,... Failed Impurities/Degradation Specifications Class III SUN PHARMACEUTICAL INDUSTRIES INC
Sep 25, 2026 Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Me... Failed Impurities/Degradation Specifications Class III SUN PHARMACEUTICAL INDUSTRIES INC
Sep 24, 2026 Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, A... Lack of Assurance of Sterility Class II Apothecary Pharma LLC
Sep 24, 2026 Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothe... Lack of Assurance of Sterility Class II Apothecary Pharma LLC
Sep 23, 2026 IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-d... Presence of particulate matter. Class II J&J INNOVATIVE MEDICINE
Sep 23, 2026 Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufa... Failed dissolution specifications. Class II Apotex Corp.
Sep 18, 2026 Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of... Failed Impurities/Degradation Specifications Class II Cipla USA, Inc.
Sep 17, 2026 Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marke... Failed Dissolution Specifications: below specification Class II Ajanta Pharma USA Inc
Sep 17, 2026 FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manuf... Lack of Assurance of Sterility Class II Aurolab Trust
Sep 15, 2026 Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.2... Lack of Assurance of Sterility Class II Insight Pharmaceuticals LLC, a Prestige Consume...
Sep 15, 2026 Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.2... Lack of Assurance of Sterility Class II Insight Pharmaceuticals LLC, a Prestige Consume...
Sep 11, 2026 Sterile Eye Drops Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02% Lu... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc.
Sep 11, 2026 Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc.
Sep 11, 2026 Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidon... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc.
Sep 11, 2026 Eye Drops MAXIMUM, REDNESS RELIEF, Sterile, 1/2 FL OZ (0.5 ML); a) exchange s... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc.
Sep 11, 2026 Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc.
Sep 11, 2026 Sterile Eye Drops, ORIGINAL, Tetrahydrozoline HCl 0.05% Redness Reliever ¿ ... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc.
Sep 11, 2026 Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc.
Sep 11, 2026 Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DIS... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc.
Sep 10, 2026 Brush Buddies, Cookies 'n Cream Ice Cream Flavored Toothpaste, Anticavity Flu... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 Brush Buddies, Whitening Anti-cavity Fluoride Toothpaste, with Baking Soda, (... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium... CGMP Deviations Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 Brush Buddies, Barbie, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243... CGMP Deviations Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 Brush Buddies, Vanilla Ice Cream Flavored Toothpaste, Anticavity Fluoride Too... CGMP Deviations Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluorid... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 evo, Advanced Whitening, Anticavity Fluoride Toothpaste, (sodium fluoride 0.2... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 Brush Buddies, Chocolate Ice Cream Flavored Toothpaste, Anticavity Fluoride T... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 Brush Buddies, Crayola Silly Scents, Anticavity Fluoride Toothpaste, (sodium ... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 Brush Buddies, Hot Wheels, Anticavity Fluoride Toothpaste, (sodium fluoride 0... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 BB (Brush Buddies) Cavity Protection, Anti-Cavity Fluoride Toothpaste, (sodiu... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED
Sep 10, 2026 Brush Buddies, My Little Pony Scents Anticavity Fluoride Toothpaste, (sodium ... CGMP Deviations. Class II PRITAM INTERNATIONAL PRIVATE LIMITED

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.