Browse Drug Recalls

2,012 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,012 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 2,012 FDA drug recalls.

Clear
DateProductReasonClassFirm
Nov 7, 2023 Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: ... Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen Class II Glenmark Pharmaceuticals Inc., USA
Nov 7, 2023 Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glen... Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen Class II Glenmark Pharmaceuticals Inc., USA
Oct 30, 2023 V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioAc... Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X i... Class III Grato Holdings, Inc.
Oct 20, 2023 Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only,... Sub-potent Drug: Lower potency than labeled. Class III Zyla Life Sciences US Inc.
Oct 18, 2023 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL S... Presence of Particulate Matter: Silicone Class I Exela Pharma Sciences LLC
Oct 17, 2023 Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bott... Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect bar... Class III AbbVie Inc.
Oct 5, 2023 Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail sto... CGMP Deviations: OTC products were stored outside of labeled temperature requirements. Class II Dollar Tree Distribution, Inc.
Oct 4, 2023 Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06... Labeling: Not Elsewhere Classified Class III Denver Solutions, LLC DBA Leiters Health
Oct 4, 2023 VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only... Labeling: Not Elsewhere Classified Class III Denver Solutions, LLC DBA Leiters Health
Oct 4, 2023 VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx onl... Labeling: Not Elsewhere Classified Class III Denver Solutions, LLC DBA Leiters Health
Sep 20, 2023 MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile O... Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0%... Class III Imprimis NJOF, LLC
Aug 29, 2023 Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 9... Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packag... Class III RB Health (US) LLC
Aug 25, 2023 Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/D... Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets,... Class I Marlex Pharmaceuticals, Inc.
Aug 25, 2023 Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Di... Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets,... Class II Marlex Pharmaceuticals, Inc.
Aug 25, 2023 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1... Class II CareFusion 213, LLC
Aug 24, 2023 Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL)... CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions dur... Class II Baxter Healthcare Corporation
Aug 18, 2023 Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF ... Subpotent Drug: Product does not contain SPF that is declared on the label. Class II HUMANRACE
Aug 18, 2023 Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Su... Subpotent Drug: Product does not contain SPF that is declared on the label. Class II HUMANRACE
Aug 14, 2023 Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial,... Labeling: Missing Label; customer complaint received that labels were partially or completely pee... Class III Baxter Healthcare Corporation
Aug 14, 2023 All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by In... CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Al... Class II Inmar Supply Chain Solutions, LLC
Aug 11, 2023 Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 pp... Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsa... Class II AVKARE LLC
Aug 11, 2023 Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NE... Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% ... Class II AVKARE LLC
Aug 10, 2023 hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v f... Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons label... Class II Colgate Palmolive Company
Aug 9, 2023 Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 7, 2023 PLUVICTO 1,000MBq/mL (27 mCi/mL), lutetium Lu 177 vipivotide tetraxetan injec... Labeling: Incorrect or Missing Lot and/or Exp Date: vials were labeled with the incorrect lot num... Class III Advanced Accelerator Applications USA, Inc.
Aug 2, 2023 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B.... Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructi... Class III B. Braun Medical Inc.
Jul 11, 2023 Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, la... Lack of Assurance of Sterility Class II Sagent Pharmaceuticals
Jun 6, 2023 GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisit... Labeling: Label Mix-up Class III HF Acquisition Co LLC
May 31, 2023 ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx on... Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg we... Class I The Harvard Drug Group LLC dba Major Pharmaceut...
May 12, 2023 ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple... Mislabeling: preservative free product labeled as preserved. Class II Empower Clinic Services LLC dba Empower Pharmacy
May 8, 2023 Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramusc... Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the p... Class III Amneal Pharmaceuticals of New York, LLC
May 1, 2023 Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed ... Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an... Class II Glenmark Therapeutics, Inc.
Apr 27, 2023 Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
Apr 27, 2023 Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
Apr 27, 2023 Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
Apr 27, 2023 Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
Apr 27, 2023 Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets... Labeling: Incorrect or Missing Package Insert Class III Teva Pharmaceuticals USA Inc
Apr 20, 2023 Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per ... Labeling: Typographical error on the upper left-hand side of the box and individual patch label t... Class III Bryant Ranch Prepack, Inc.
Apr 19, 2023 Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Sol... Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the label... Class II Seatex LLC
Apr 6, 2023 Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 m... CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation. Class II Pharma Nobis LLC
Mar 31, 2023 Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever R... CGMP deviation: product outside labeled storage temperature requirements. Class II Family Dollar Stores, Llc.
Mar 31, 2023 Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged ... CGMP deviation: product outside labeled storage temperature requirements. Class II Family Dollar Stores, Llc.
Mar 31, 2023 Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAI... CGMP deviation: product outside labeled storage temperature requirements. Class II Family Dollar Stores, Llc.
Mar 31, 2023 Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count ... CGMP deviation: product outside labeled storage temperature requirements. Class II Family Dollar Stores, Llc.
Mar 27, 2023 Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip ... Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. Class III Pine Pharmaceuticals, LLC
Mar 16, 2023 Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/m... Labeling; Incorrect NDC number on outer carton of product. Class III Focus Health Group Inc
Mar 9, 2023 JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-01... Labeling: Label Mix-up Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Mar 8, 2023 MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed ... Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry... Class III Pfizer Inc.
Feb 28, 2023 Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose ... Labeling: Not elsewhere classified Class II Sagent Pharmaceuticals Inc
Feb 17, 2023 DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Ph... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Akron Pharma, 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.