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
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
Aug 13, 2026 Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, P... Failed Stability Specifications Class II Safecor Health, LLC
Aug 13, 2026 Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, P... Failed Stability Specifications Class II Safecor Health, LLC
Aug 13, 2026 Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx o... Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance c... Class II Apotex Corp.
Aug 12, 2026 Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. ... Presence of Particulate matter. Class I B BRAUN MEDICAL INC
Aug 11, 2026 Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, R... Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified ... Class I American Regent, Inc.
Aug 10, 2026 Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx ... Presence of particulate matter:An internal investigation at the firm found the product to contain... Class I Fresenius Kabi USA, LLC
Aug 10, 2026 Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus,... CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for micro... Class II Church & Dwight Co., Inc.
Aug 8, 2026 MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufac... cGMP Deviations Class II SHANTOU Qiwei industrial Co., Ltd
Aug 7, 2026 Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, ... Presence of Foreign Tablets/Capsules Class III Bionpharma Inc.
Aug 7, 2026 Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 5140... CGMP deviations: tablets with black specks. Class II Golden State Medical Supply Inc.
Aug 6, 2026 Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY ... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY ... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 unit... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) i... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Sin... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL ... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY ... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per ... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALA... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose C... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 5... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/m... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL)... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 unit... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALA... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-coun... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx ... Presence of particulate matter: glass and stopper piece Class II Mallinckrodt Hospital Products Inc.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx ... Subpotent Drug Class II ACCORD HEALTHCARE, INC.
Aug 6, 2026 Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Onl... Subpotent Drug Class II ACCORD HEALTHCARE, INC.

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.