Browse Drug Recalls

557 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 557 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 557 FDA drug recalls in 2024.

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Date	Product	Reason	Class	Firm
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 30, 2024	Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-cou...	CGMP Deviations	Class II	Glenmark Pharmaceuticals Inc., USA
May 30, 2024	Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou...	Failed Dissolution Specifications	Class I	Glenmark Pharmaceuticals Inc., USA
May 30, 2024	Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-cou...	Failed Dissolution Specifications	Class I	Glenmark Pharmaceuticals Inc., USA
May 30, 2024	Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou...	CGMP Deviations	Class II	Glenmark Pharmaceuticals Inc., USA
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	Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati...	Defective Container	Class III	Organon Llc
May 28, 2024	Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati...	Defective Container	Class III	Organon Llc
May 28, 2024	Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose ...	Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.	Class I	Sagent Pharmaceuticals
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 28, 2024	Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuati...	Defective Container	Class III	Organon 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	Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Do...	Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.	Class I	Sagent Pharmaceuticals
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 24, 2024	suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broa...	Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)	Class I	SYNCHRONICITY SPA INC, DBA SUNTE
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	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 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 22, 2024	Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mf...	Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide...	Class III	Eugia US LLC
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	Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By:...	Discoloration: Brownish tablets	Class II	Contract Pharmacal Corporation
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 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	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 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 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 16, 2024	Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manuf...	Failed Impurities/Degradation Specifications.	Class III	Zydus Pharmaceuticals (USA) Inc
May 16, 2024	Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Risin...	Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Pack...	Class III	Rising Pharma Holding, Inc.
May 16, 2024	Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufa...	Failed Impurities/Degradation Specifications.	Class III	Zydus Pharmaceuticals (USA) 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	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	Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5...	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 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	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	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	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	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	Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, ...	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	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 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	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 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	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 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	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	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	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

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.