Browse Drug Recalls

3,368 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,368 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 3,368 FDA drug recalls.

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DateProductReasonClassFirm
Jan 18, 2024 Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distri... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 16, 2024 OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcoh... CGMP Deviations: products may not conform to the labeled specifications. Class II Den-Mat Holdings, LLC
Jan 16, 2024 Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flav... CGMP Deviations: products may not conform to the labeled specifications. Class II Den-Mat Holdings, LLC
Dec 28, 2023 Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guai... CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... Class II Seaway Pharma Inc.
Dec 28, 2023 Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydro... CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... Class II Seaway Pharma Inc.
Dec 28, 2023 Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump M... CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... Class II Seaway Pharma Inc.
Dec 28, 2023 Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydro... CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the... Class II Seaway Pharma Inc.
Dec 20, 2023 Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 coun... CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit. Class II Lupin Pharmaceuticals Inc.
Dec 13, 2023 Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-C... CGMP Deviations: Stability data does not support expiry date. Class II Private Label Partners, Inc.
Dec 11, 2023 Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Ma... CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product. Class II Legacy Pharmaceutical Packaging LLC
Nov 9, 2023 Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C;... cGMP Deviations Class II Family Medical Supply Inc
Oct 19, 2023 Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dro... CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements. Class II Safecor Health, LLC
Oct 18, 2023 Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender ... CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels ... Class II Integrity Bio-Chemicals LLC
Oct 18, 2023 Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Sc... CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels ... Class II Integrity Bio-Chemicals LLC
Oct 18, 2023 Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla ... CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels ... Class II Integrity Bio-Chemicals LLC
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 Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ing... CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and release... Class II MEDLINE INDUSTRIES, LP - Northfield
Aug 26, 2023 Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr... CGMP Deviations Class II Dr. Berne's Whole Health Products
Aug 26, 2023 Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr.... CGMP Deviations Class II Dr. Berne's Whole Health Products
Aug 26, 2023 Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr.... CGMP Deviations Class II Dr. Berne's Whole Health Products
Aug 26, 2023 Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distri... CGMP Deviations Class II Dr. Berne's Whole Health Products
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 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 9, 2023 YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, pa... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
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 9, 2023 Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bot... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged ... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manuf... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and pota... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% ... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 2, 2023 Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2... CGMP Deviations Class II Parker Laboratories, Inc.
Aug 2, 2023 Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775... CGMP Deviations Class II Parker Laboratories, Inc.
Aug 2, 2023 Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-0... CGMP Deviations Class II Parker Laboratories, Inc.
Aug 2, 2023 Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate... CGMP Deviations Class II Parker Laboratories, Inc.
Aug 2, 2023 Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 307... CGMP Deviations Class II Parker Laboratories, Inc.
Jul 21, 2023 Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distri... cGMP deviations: Batch was released prior to approval. Class II Aurobindo Pharma USA Inc.
Jul 21, 2023 Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules pe... CGMP deviation: product released prior to supplier approval. Class II The Ritedose Corporation
Jul 21, 2023 Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distri... cGMP deviations: Batch was released prior to approval. Class II Aurobindo Pharma USA Inc.
Jul 20, 2023 FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL ... cGMP deviations: due to shipment of rejected units. Class II SCA Pharmaceuticals
Jul 10, 2023 PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60... CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... Class II New England Life Care, Inc. dba Advanced Compou...
Jul 10, 2023 Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic... CGMP Deviation: impurities exceed allowable limits. Class II Tenn South Distillery LLC dba Big Machine Disti...
Jul 10, 2023 SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, A... CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... Class II New England Life Care, Inc. dba Advanced Compou...
Jul 10, 2023 ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Com... CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... Class II New England Life Care, Inc. dba Advanced Compou...
Jul 10, 2023 Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515... CGMP Violations- that spaces adjacent to the production area may have been compromised at the tim... Class II New England Life Care, Inc. dba Advanced Compou...
Jun 23, 2023 Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), pac... CGMP Deviations: use of non-food grade lubricant in mixing vessel. Class II Kramer Laboratories, Inc.
Jun 23, 2023 Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppress... CGMP Deviations: use of non-food grade lubricant in mixing vessel. Class II Kramer Laboratories, Inc.
Jun 13, 2023 Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL O... CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... Class II K.C. Pharmaceuticals, Inc
Jun 13, 2023 Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polye... CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... Class II K.C. Pharmaceuticals, Inc
Jun 12, 2023 Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 va... cGMP deviations: potential for Microbial Contamination of Non-Sterile Products Class II Ferring Pharmaceuticals Inc
Jun 5, 2023 Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufa... cGMP deviations Class II Homeocare Laboratories, 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.