Browse Drug Recalls

14,449 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,449 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 14,449 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Jun 20, 2024 Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) pa... CGMP deviations Class II Little Moon Essentials LLC
Jun 18, 2024 DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% D... This product is being recalled due to the tube weld failure presents itself as a slow leak and ca... Class II Fresenius Medical Care Holdings, Inc.
Jun 18, 2024 Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 bl... Failed dissolution specifications: out of specification result obtained during routine stability ... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Jun 17, 2024 Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count... Failed dissolution specifications: this product is being recalled due to this batch not meeting d... Class II Trigen Laboratories
Jun 17, 2024 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro... Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assemb... Class II Baxter Healthcare Corporation
Jun 12, 2024 Zilretta (triamcinolone acetonide extended-release injectable suspension), 32... Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing... Class II PACIRA PHARMACEUTICALS INC
Jun 10, 2024 Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), p... Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination Class II Brands International Corporation
Jun 7, 2024 Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured... Presence of foreign substance. Class II Dr. Reddy's Laboratories, Inc.
Jun 5, 2024 STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473... Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism Class II Homeocare Laboratories, Inc.
Jun 4, 2024 Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-co... Subpotent Drug Class II Teva Pharmaceuticals USA, Inc
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 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... 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 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 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 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 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 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 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 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 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 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 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

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.