Browse Drug Recalls

3,394 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,394 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 3,394 FDA drug recalls.

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DateProductReasonClassFirm
Feb 9, 2024 Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net ... CGMP Deviations: potential presence of Burkholderia cepacia complex Class II Apotex Corp.
Feb 7, 2024 Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MF... cGMP Deviations: Products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Feb 7, 2024 Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vi... cGMP Deviations: Products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Feb 7, 2024 Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Sy... cGMP Deviations: Products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Feb 6, 2024 Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP uni... cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Af... Class II Mallinckrodt Hospital Products Inc.
Feb 6, 2024 Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only... cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Af... Class II Mallinckrodt Hospital Products Inc.
Feb 1, 2024 Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactur... CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on ... Class II NATCO Pharma Limited
Jan 25, 2024 Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent Internat... CGMP Deviations Class II Alpha Aromatics
Jan 25, 2024 Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distribut... CGMP Deviations Class II Amerisource Health Services LLC
Jan 19, 2024 Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic,... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 19, 2024 Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS CGMP Deviations Class II OMEZA LLC
Jan 19, 2024 Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials CGMP Deviations Class II OMEZA LLC
Jan 19, 2024 Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 d... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 19, 2024 Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 19, 2024 Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 19, 2024 CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 18, 2024 Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hou... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, D... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distr... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablet... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
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.

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.