Browse Drug Recalls

18,008 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18,008 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 18,008 FDA drug recalls.

DateProductReasonClassFirm
Sep 23, 2026 Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufa... Failed dissolution specifications. Class II Apotex Corp.
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 8, 2026 Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Do... Crystallization Class II Par Health USA, LLC
Sep 8, 2026 Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by:... Defective Container; packets were found to be either empty or partially full. Class II Amneal Pharmaceuticals, LLC
Sep 4, 2026 Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials pe... Lack of Assurance of Sterility Class II Pfizer
Sep 3, 2026 Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufact... Failed Dissolution Specifications Class II Inventia Healthcare Limited
Sep 3, 2026 fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0... Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of... Class II OurPharma LLC
Sep 1, 2026 Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Labor... Microbial contamination of topical product. Class II SV Labs Toronto Corporation
Sep 1, 2026 Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0... Microbial contamination of topical product. Class II SV Labs Toronto Corporation
Aug 31, 2026 Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a car... Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor c... Class II TerSera Therapeutics LLC
Aug 31, 2026 Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Tar... Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 2... Class II SUN PHARMA /TARO
Aug 31, 2026 Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx o... Failed dissolution specifications. Class III Supernus Pharmaceuticals, Inc.
Aug 28, 2026 Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subc... Defective Delivery System: Possibility of no medication in the prefilled pen. Class II Amneal Pharmaceuticals of New York, LLC
Aug 27, 2026 Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Mac... Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. Class III Macleods Pharmaceuticals Limited
Aug 26, 2026 Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile,... Failed Dissolution Specifications Class II Mylan Pharmaceuticals Inc
Aug 25, 2026 Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Ma... Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) d... Class III Ajanta Pharma USA Inc
Aug 24, 2026 Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per ... Subpotent Drug Class III ImprimisRx NJ LLC
Aug 24, 2026 traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactur... Presence of Foreign Tablets/Capsules Class II Teva Pharmaceuticals USA, Inc
Aug 24, 2026 Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) ... Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclo... Class II Hikma Pharmaceuticals USA INC.
Aug 21, 2026 Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine ... Superpotent Drug Class I VITRUVIAS THERAPEUTICS INC
Aug 21, 2026 Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSM... Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled ... Class II Golden State Medical Supply Inc.
Aug 21, 2026 Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (C... CGMP Deviations: Potential contamination of raw material Class II Lexia LLC
Aug 21, 2026 Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Iso... CGMP Deviations: Potential contamination of raw material Class II Lexia LLC
Aug 20, 2026 Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant ... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Di... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 c... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, ... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye ... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye ... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 20, 2026 TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellul... Lack of Assurance of Sterility Class II Sterling Pharmaceutical Services LLC
Aug 19, 2026 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Contai... Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, ... Class I B BRAUN MEDICAL INC
Aug 19, 2026 Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose ... Failed Stability Specifications: Out of specification stability result for the protein concentrat... Class III Chiesi USA, Inc.
Aug 19, 2026 Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, D... Labeling: Label Mix-up Class III American Health Packaging
Aug 18, 2026 2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Pro... Cross Contamination with Other Products Class II Sage Products, LLC
Aug 17, 2026 Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufacture... Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance c... Class II Mylan Pharmaceuticals Inc
Aug 17, 2026 Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corpo... Presence of Particulate Matter: particulate matter identified as stainless steel particles in the... Class I Baxter Healthcare Corporation
Aug 17, 2026 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 2... Presence of particulate matter: Particulates identified as fiberglass Class I Baxter Healthcare Corporation
Aug 14, 2026 THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocr... Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 5... Class II Allies Group Inc.
Aug 14, 2026 THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocr... Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 5... Class II Allies Group Inc.
Aug 14, 2026 THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocr... Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 5... Class II Allies Group Inc.
Aug 14, 2026 THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocr... Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 5... Class II Allies Group Inc.
Aug 13, 2026 Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, P... Failed Stability Specifications Class II Safecor Health, LLC
Aug 13, 2026 Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PA... Failed Stability Specifications Class II Safecor Health, LLC
Aug 13, 2026 Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, P... Failed Stability Specifications Class II Safecor Health, LLC
Aug 13, 2026 Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, P... Failed Stability Specifications Class II Safecor Health, LLC

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.