Browse Drug Recalls
2,002 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,002 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 2,002 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Feb 8, 2023 | Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0... | Lack of assurance of sterility: Suspected microbial growth present on external label packaging. | Class II | Apollo Care |
| Feb 8, 2023 | Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Redd... | Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bot... | Class II | Dr. Reddy's Laboratories, Inc. |
| Dec 16, 2022 | Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton... | Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-coun... | Class II | Hikma Pharmaceuticals USA Inc. |
| Dec 6, 2022 | Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 05... | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... | Class I | Glaxosmithkline Consumer Healthcare Holdings DB... |
| Dec 6, 2022 | Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever ... | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... | Class I | Glaxosmithkline Consumer Healthcare Holdings DB... |
| Dec 6, 2022 | Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Relieve... | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ... | Class I | Glaxosmithkline Consumer Healthcare Holdings DB... |
| Dec 1, 2022 | Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syr... | Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained pro... | Class I | BayCare Integrated Service Center, LLC /dba Bay... |
| Nov 29, 2022 | Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufacture... | Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomyc... | Class I | Accord Healthcare, Inc. |
| Nov 14, 2022 | Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10... | Labeling: Not elsewhere classified; the product is being recalled because of customer complaints ... | Class III | Acella Pharmaceuticals, LLC |
| Nov 14, 2022 | Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 1... | Labeling: Not elsewhere classified; the product is being recalled because of customer complaints ... | 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.