Browse Drug Recalls
3,430 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,430 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 3,430 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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. |
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.