Browse Drug Recalls

14,136 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,136 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 14,136 FDA drug recalls — Class II.

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Date	Product	Reason	Class	Firm
May 30, 2024	Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for or...	Failed Content Uniformity Specifications	Class II	Lupin Pharmaceuticals Inc.
May 28, 2024	Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufact...	Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablet...	Class II	Winder Laboratories, LLC
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 28, 2024	Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz....	cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel e...	Class II	Denison Pharmaceuticals, LLC
May 24, 2024	suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple S...	CGMP Deviations	Class II	SYNCHRONICITY SPA INC, DBA SUNTE
May 23, 2024	Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL ...	Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phos...	Class II	Eugia US LLC
May 23, 2024	Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials...	Lack of Assurance of Sterility: Leaking vials	Class II	Dr. Reddy's Laboratories, Inc.
May 22, 2024	OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 3...	Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undec...	Class II	MexHealth LLC
May 20, 2024	Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San F...	Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo ...	Class II	Genentech, Inc.
May 20, 2024	Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By:...	Discoloration: Brownish tablets	Class II	Contract Pharmacal Corporation
May 20, 2024	Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dos...	Lack of Assurance of Sterility-The potential for incomplete crimp seals.	Class II	Pfizer Inc.
May 20, 2024	Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpu...	Lack of Assurance of Sterility-The potential for incomplete crimp seals.	Class II	Pfizer Inc.
May 17, 2024	Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mf...	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Class II	Breckenridge Pharmaceutical, Inc
May 15, 2024	EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a...	Lack of Assurance of Sterility: Complaints of syringe breakage	Class II	Regeneron Pharmaceuticals Inc
May 14, 2024	Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraoc...	Lack of Assurance of Sterility	Class II	Imprimis NJOF, LLC
May 14, 2024	Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intra...	Lack of Assurance of Sterility	Class II	Imprimis NJOF, LLC
May 14, 2024	Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, ...	Lack of Assurance of Sterility	Class II	Imprimis NJOF, LLC
May 14, 2024	Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Pres...	Lack of Assurance of Sterility	Class II	Imprimis NJOF, LLC
May 14, 2024	Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5...	Lack of Assurance of Sterility	Class II	Imprimis NJOF, LLC
May 14, 2024	niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL...	Lack of Assurance of Sterility.	Class II	American Regent, Inc.
May 14, 2024	Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Sing...	Lack of Assurance of Sterility	Class II	Imprimis NJOF, LLC
May 14, 2024	Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Sing...	Lack of Assurance of Sterility	Class II	Imprimis NJOF, LLC
May 14, 2024	Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single...	Lack of Assurance of Sterility	Class II	Imprimis NJOF, LLC
May 13, 2024	Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottl...	CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox...	Class II	Golden State Medical Supply Inc.
May 13, 2024	Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit...	CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab...	Class II	Glenmark Pharmaceuticals Inc., USA
May 13, 2024	Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-...	CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab...	Class II	Glenmark Pharmaceuticals Inc., USA
May 13, 2024	Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Mult...	Subpotent product in addition to having out-of-specification results for impurities.	Class II	American Regent, Inc.
May 10, 2024	Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufact...	CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab...	Class II	Glenmark Pharmaceuticals Inc., USA
May 10, 2024	Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred ...	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Class II	Preferred Pharmaceuticals, Inc.
May 10, 2024	Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufa...	CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptab...	Class II	Glenmark Pharmaceuticals Inc., USA
May 8, 2024	Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx...	Defective container: lack of seal integrity.	Class II	Lupin Pharmaceuticals 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
May 7, 2024	Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-c...	Presence of foreign substance: plastic-like substance.	Class II	MACLEODS PHARMA USA, INC
May 6, 2024	Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distribute...	Presence of Foreign Substance: metal in tablet	Class II	Rubicon Research Private Limited
May 2, 2024	TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3...	Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported findin...	Class II	RemedyRepack Inc.
May 1, 2024	CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Fl...	Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria	Class II	Pharma Nobis LLC
May 1, 2024	Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free G...	Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria	Class II	Pharma Nobis LLC
Apr 30, 2024	Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Onl...	Failed Impurities/Degradation Specifications	Class II	Viatris Inc
Apr 30, 2024	Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Onl...	Failed Impurities/Degradation Specifications	Class II	Viatris Inc
Apr 29, 2024	Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only...	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Class II	Breckenridge Pharmaceutical, Inc
Apr 29, 2024	Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles...	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Class II	Breckenridge Pharmaceutical, Inc
Apr 29, 2024	Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, M...	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Class II	Breckenridge Pharmaceutical, Inc
Apr 26, 2024	traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distri...	Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count t...	Class II	Rubicon Research Private Limited
Apr 25, 2024	MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 m...	Presence of Particulate Matter: Potential for black particulates in the drug product.	Class II	Sagent Pharmaceuticals
Apr 25, 2024	Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (N...	Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several co...	Class II	FDC Limited
Apr 24, 2024	Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC...	Discoloration: Dotted and yellow spots on tablets	Class II	Aurobindo Pharma USA Inc.
Apr 24, 2024	Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC ...	Discoloration: Dotted and yellow spots on tablets	Class II	Aurobindo Pharma USA Inc.
Apr 24, 2024	Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vial...	Presence of Foreign Substance: This oil based product may contain trace amounts of water for inje...	Class II	SOMERSET THERAPEUTICS LLC
Apr 24, 2024	Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 m...	Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.	Class II	Lupin Pharmaceuticals Inc.
Apr 24, 2024	Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 m...	Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.	Class II	Lupin Pharmaceuticals 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.