Browse Drug Recalls
2,138 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,138 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 2,138 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 1, 2024 | Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1... | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. | Class I | Baxter Healthcare Corporation |
| Jul 2, 2024 | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... | Cross contamination with other products | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 2, 2024 | Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufa... | Cross contamination with other products | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 2, 2024 | Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Singl... | Cross contamination with other products. | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jul 2, 2024 | Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a)... | Cross contamination with other products. | Class III | Zydus Pharmaceuticals (USA) Inc |
| Jun 10, 2024 | Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), p... | Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination | Class II | Brands International Corporation |
| Jun 5, 2024 | STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distri... | Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms | Class I | Homeocare Laboratories, Inc. |
| Jun 5, 2024 | STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473... | Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism | Class II | Homeocare Laboratories, Inc. |
| May 24, 2024 | suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broa... | Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) | Class I | SYNCHRONICITY SPA INC, DBA SUNTE |
| May 1, 2024 | CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Fl... | Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria | Class II | Pharma Nobis LLC |
| May 1, 2024 | Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free G... | Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria | Class II | Pharma Nobis LLC |
| Apr 9, 2024 | Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only,... | Cross Contamination with Other Products | Class III | Second Tokushima Factory, Otsuka Pharmaceutical... |
| Apr 9, 2024 | Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 5... | Cross Contamination with Other Products | Class III | Second Tokushima Factory, Otsuka Pharmaceutical... |
| Apr 9, 2024 | Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, ... | Cross Contamination with Other Products | Class III | Second Tokushima Factory, Otsuka Pharmaceutical... |
| Apr 9, 2024 | Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only,... | Cross Contamination with Other Products | Class III | Second Tokushima Factory, Otsuka Pharmaceutical... |
| Mar 28, 2024 | Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cart... | Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. | Class I | AvKARE |
| Mar 23, 2024 | Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle,... | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Class I | Aruba Aloe Balm N.V. |
| Mar 23, 2024 | Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in... | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Class I | Aruba Aloe Balm N.V. |
| Mar 4, 2024 | Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufact... | Cross Contamination with Other Products:(mycophenolate mofetil). | Class III | Novitium Pharma LLC |
| Mar 4, 2024 | Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 4, 2024 | Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 1, 2024 | TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 o... | Chemical Contamination; presence of benzene. | Class I | Insight Pharmaceuticals LLC, a Prestige Consume... |
| 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 |
| 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 26, 2023 | Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorph... | Microbial Contamination of Non-Sterile Products | Class I | Haleon US Holdings LLC |
| Dec 26, 2023 | Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramin... | Microbial Contamination of Non-Sterile Products | Class I | Haleon US Holdings LLC |
| Dec 21, 2023 | Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Fre... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Class II | Pharma Nobis LLC |
| Dec 21, 2023 | Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can... | Chemical Contamination: presence of benzene | Class I | Insight Pharmaceuticals LLC, a Prestige Consume... |
| Dec 21, 2023 | Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Class II | Pharma Nobis LLC |
| Dec 21, 2023 | CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Fla... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Class II | Pharma Nobis LLC |
| Dec 21, 2023 | Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxativ... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Class II | Pharma Nobis LLC |
| Dec 21, 2023 | Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution... | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. | Class II | Pharma Nobis LLC |
| Nov 22, 2023 | TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET... | Chemical Contamination; presence of benzene. | Class I | Insight Pharmaceuticals Corporation |
| Nov 6, 2023 | VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manu... | Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicilliu... | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 18, 2023 | Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottle... | Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus. | Class I | VistaPharm LLC |
| Sep 29, 2023 | ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* ... | Microbial contamination of Non-Sterile Products | Class II | Biomic Sciences, LLC dba ION Intelligence of Na... |
| Sep 29, 2023 | Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA | Microbial contamination of Non-Sterile Products | Class II | Biomic Sciences, LLC dba ION Intelligence of Na... |
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.