Browse Drug Recalls

17,539 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,539 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 17,539 FDA drug recalls.

DateProductReasonClassFirm
May 20, 2024 Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By:... Discoloration: Brownish tablets Class II Contract Pharmacal Corporation
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 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 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 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 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 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 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 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 (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single... 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 Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5... 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 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 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, 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 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 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 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, 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 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 Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. ... Failed Impurities/Degradation Specifications Class III Dr. Reddy's Laboratories, 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 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 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, 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 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 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 25, 2024 Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for... Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing ... Class III Viatris Inc
Apr 24, 2024 Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual... Presence of Foreign Substance; Broken metal piece found embedded in tablet. Class II Coast Quality Pharmacy, LLC dba Anazao Health
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.
Apr 24, 2024 Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle... Subpotent drug Class III Acella Pharmaceuticals, LLC

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.