Browse Drug Recalls

2,029 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,029 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 2,029 FDA drug recalls.

Clear
DateProductReasonClassFirm
Dec 18, 2024 medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only... CGMP Deviations Class II Eugia US LLC
Dec 18, 2024 Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant... LABELING: LABEL MIX-UP Class III AvKARE
Dec 12, 2024 Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, M... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Dec 12, 2024 Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, In... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Dec 12, 2024 Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufacture... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Dec 12, 2024 Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma,... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Dec 12, 2024 Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactur... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Dec 12, 2024 Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactur... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Dec 12, 2024 Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufact... Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. Class III Akron Pharma, Inc.
Nov 26, 2024 Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit co... Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product Class II Curium US, LLC
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tab... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablet... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 18, 2024 Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 ta... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... Class I Endo USA, Inc.
Nov 14, 2024 Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-D... Labeling: Not Elsewhere Classified - Wrong NDC number Class III Zydus Pharmaceuticals (USA) Inc
Oct 30, 2024 Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled S... Labeling: Missing Label Class II Baxter Healthcare Corporation
Oct 18, 2024 Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for... Labeling: Label Mix-Up Class II AvKARE
Oct 18, 2024 Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured f... Labeling: Label Mix-Up Class II AvKARE
Sep 11, 2024 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bot... Temperature abuse: Products exposed to improper temperature above drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Sep 11, 2024 First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients:... Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes ... Class II Zhejiang Jingwei Pharmaceutical Co., Ltd.
Aug 20, 2024 Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g... LABELING: LABEL MIX-UP. Class III Elevate Oral Care
Jul 18, 2024 Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid ... Label mix-up: Carton incorrectly labeled. Class III Granules Consumer Health Inc.
Jul 11, 2024 Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 ... Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the ... Class I Aurobindo Pharma USA Inc
Jul 10, 2024 Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per ... Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg ins... Class I Endo Pharmaceuticals, Inc.
Jul 8, 2024 Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose b... Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found ... Class I Hikma Pharmaceuticals USA Inc.
Jun 26, 2024 Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets ... Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on pa... Class III Dr. Reddy's Laboratories, Inc.
Jun 25, 2024 Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by:... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 25, 2024 Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed b... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 25, 2024 Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz ... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 25, 2024 Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by... Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. Class III GLOBAL WIDGET LLC
Jun 21, 2024 Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Package... Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrec... Class I A-S Medication Solutions LLC
May 31, 2024 Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: ... Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbita... Class II RemedyRepack Inc.
May 31, 2024 Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of ho... Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferr... Class III Washington Homeopathic Products, Inc.
May 28, 2024 Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the fo... Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum... Class II Consumer Product Partners, LLC
May 17, 2024 Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, ... Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*,... Class III GlaxoSmithKline LLC
May 10, 2024 Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Rel... Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on ... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), ... Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed),... Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixe... Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixe... Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 7, 2024 Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectab... Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C. Class II PACIRA PHARMACEUTICALS INC
Apr 30, 2024 Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged... Labeling: Wrong Barcode Class III Hikma Injectables USA Inc
Apr 29, 2024 Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL,... Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. Class I Hikma Injectables USA Inc
Apr 20, 2024 Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, Thi... Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate Class I Revive Rx LLC dba Revive Rx Pharmacy
Apr 2, 2024 Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent... Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... Class III X-Gen Pharmaceuticals Inc.
Apr 2, 2024 Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, ... Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... Class III X-Gen Pharmaceuticals Inc.
Mar 6, 2024 Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), ... Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, spec... Class II B. Braun Medical Inc
Feb 12, 2024 CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1... CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was... Class II MCKESSON CORPORATION
Feb 7, 2024 Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MF... cGMP Deviations: Products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Feb 7, 2024 Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vi... cGMP Deviations: Products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office

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.