Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
Jul 17, 2025 DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bott... Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... Class I DermaRite Industries, LLC
Jul 17, 2025 DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol ... Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... Class I DermaRite Industries, LLC
Jul 17, 2025 KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL... Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... Class I DermaRite Industries, LLC
Jul 15, 2025 Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only,... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit Class II Breckenridge Pharmaceutical, Inc.
Jul 11, 2025 Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-00... CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... Class II Nostrum Laboratories, Inc.
Jul 10, 2025 Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder ... CGMP Deviations Class II A.P. Deauville, LLC
Jul 10, 2025 Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units... CGMP Deviations; particulates identified during visual inspection Class II Pfizer Inc.
Jul 10, 2025 Beauty & Skincare Power Stick original nourishing invisible protection roll-... CGMP Deviations Class II A.P. Deauville, LLC
Jul 10, 2025 Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-... CGMP Deviations Class II A.P. Deauville, LLC
Jul 10, 2025 Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units ... CGMP Deviations; particulates identified during visual inspection Class II Pfizer Inc.
Jul 9, 2025 Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides... Failed Dissolution Specifications. Class II Strides Pharma, Inc.
Jul 9, 2025 Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only,... CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... Class II Ascend Laboratories, LLC
Jul 9, 2025 Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy Subpotent Drug Class II Boothwyn Pharmacy LLC
Jul 9, 2025 Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy Subpotent Drug Class II Boothwyn Pharmacy LLC
Jul 9, 2025 Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only... CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... Class II Ascend Laboratories, LLC
Jul 9, 2025 Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy Subpotent Drug Class II Boothwyn Pharmacy LLC
Jul 9, 2025 Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution... Sub-Potent Drug: Subpotent assay results during stability testing. Class III Imprimis NJOF, LLC
Jul 9, 2025 Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496 Subpotent Drug Class III Boothwyn Pharmacy LLC
Jul 9, 2025 Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton,... Sub-Potent Drug: Subpotent assay results during stability testing. Class II Imprimis NJOF, LLC
Jul 7, 2025 CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton... Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 7, 2025 Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen,... Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 7, 2025 ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walm... Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 7, 2025 H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China wi... Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 7, 2025 RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200... Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 7, 2025 Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Sin... Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 5, 2025 Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. Class II FDC Limited
Jul 2, 2025 Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle,... Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 i... Class II Lupin Pharmaceuticals Inc.
Jul 1, 2025 PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated... Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identifi... Class II Central Admixture Pharmacy Services, Inc (CAPS)...
Jun 30, 2025 Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carto... Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. Class II Cipla USA, Inc.
Jun 30, 2025 Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, M... Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250m... Class II Dr. Reddy's Laboratories, Inc.
Jun 30, 2025 Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, ... CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Breckenridge Pharmaceutical, Inc.
Jun 27, 2025 Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or ... Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vial... Class I Sandoz Inc
Jun 27, 2025 Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 milli... Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labele... Class I Sandoz Inc
Jun 27, 2025 clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelica... Failed Impurities/Degradation Specifications: an out of specification result observed in degradat... Class II Lupin Pharmaceuticals Inc.
Jun 26, 2025 Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... Failed Impurity/Degradation Specifications Class III AvKARE
Jun 26, 2025 Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... Failed Impurity/Degradation Specifications Class III AvKARE
Jun 24, 2025 Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100... Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the ... Class II Granules Pharmaceuticals Inc.
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx O... Subpotent Drug: Assay below the approved specification Class II ACCORD HEALTHCARE, INC.
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx ... Subpotent Drug: Assay below the approved specification Class II ACCORD HEALTHCARE, INC.
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx ... Subpotent Drug: Assay below the approved specification Class II ACCORD HEALTHCARE, INC.
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx On... Subpotent Drug: Assay below the approved specification Class II ACCORD HEALTHCARE, INC.
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Onl... Subpotent Drug: Assay below the approved specification Class II ACCORD HEALTHCARE, INC.
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx O... Subpotent Drug: Assay below the approved specification Class II ACCORD HEALTHCARE, INC.
Jun 20, 2025 Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only... Subpotent Drug: Assay below the approved specification Class II ACCORD HEALTHCARE, INC.
Jun 20, 2025 Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles... Product Mix Up: This product is being recalled because of a complaint received that a sealed bott... Class II Lupin Pharmaceuticals Inc.
Jun 19, 2025 Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons,... Defective container; blister packaging inadequately sealed. Class II The Harvard Drug Group LLC
Jun 19, 2025 Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packag... Defective container; blister packaging inadequately sealed. Class II The Harvard Drug Group LLC
Jun 16, 2025 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containe... Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal proc... Class II B BRAUN MEDICAL INC
Jun 16, 2025 Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded p... Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot n... Class III Qualgen, LLC
Jun 16, 2025 Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only,... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES 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.