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Safety · Official FDA Data
Recent prescription and over-the-counter drug recalls reported to the FDA, including contamination, mislabeling, and potency problems.
Chiesi USA, Inc.
Product: CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.
Reason: Lack of Assurance of Sterility
FDA recall #D-0689-2026 · Ongoing
Bell Pharmaceuticals, Inc
Product: QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA recall #D-0680-2026 · Ongoing
Bell Pharmaceuticals, Inc
Product: Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Prairie, WI 53158, NDC 68229-102-01.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA recall #D-0679-2026 · Ongoing
Bell Pharmaceuticals, Inc
Product: LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA recall #D-0685-2026 · Ongoing
Bell Pharmaceuticals, Inc
Product: FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA recall #D-0683-2026 · Ongoing
CareFusion 213, LLC
Product: BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31
Reason: Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
FDA recall #D-0690-2026 · Ongoing
Bell Pharmaceuticals, Inc
Product: CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA recall #D-0688-2026 · Ongoing
Padagis US LLC
Product: Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Reason: Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
FDA recall #D-0677-2026 · Ongoing
Bell Pharmaceuticals, Inc
Product: meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA recall #D-0687-2026 · Ongoing
Bell Pharmaceuticals, Inc
Product: CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895,
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA recall #D-0678-2026 · Ongoing
Bell Pharmaceuticals, Inc
Product: TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA recall #D-0681-2026 · Ongoing
Bell Pharmaceuticals, Inc
Product: AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA recall #D-0682-2026 · Ongoing
Bell Pharmaceuticals, Inc
Product: GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA recall #D-0684-2026 · Ongoing
Bell Pharmaceuticals, Inc
Product: Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141.
Reason: SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA recall #D-0686-2026 · Ongoing
ONESOURCE SPECIALTY PHARMA LIMITED
Product: Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31
Reason: Failed Impurities/Degradation Specifications
FDA recall #D-0662-2026 · Ongoing
Gasco Industrial Corp.
Product: Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA
Reason: Subpotent drug
FDA recall #D-0666-2026 · Ongoing
Gasco Industrial Corp.
Product: Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.
Reason: Subpotent drug
FDA recall #D-0667-2026 · Ongoing
Gasco Industrial Corp.
Product: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.
Reason: Subpotent drug
FDA recall #D-0670-2026 · Ongoing
Shimoga Chemicals
Product: Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.
Reason: cGMP deviations
FDA recall #D-0691-2026 · Ongoing
Reliance Life Sciences Private Limited
Product: Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01
Reason: Lack of Sterility Assurance
FDA recall #D-0672-2026 · Ongoing
Gasco Industrial Corp.
Product: Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3
Reason: Subpotent drug
FDA recall #D-0665-2026 · Ongoing
Gasco Industrial Corp.
Product: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924
Reason: Subpotent drug
FDA recall #D-0668-2026 · Ongoing
Reliance Life Sciences Private Limited
Product: Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01
Reason: Lack of Sterility Assurance
FDA recall #D-0673-2026 · Ongoing
Reliance Life Sciences Private Limited
Product: Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01
Reason: Lack of Sterility Assurance
FDA recall #D-0671-2026 · Ongoing
Reliance Life Sciences Private Limited
Product: Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01
Reason: Lack of Sterility Assurance
FDA recall #D-0674-2026 · Ongoing
BioMed Laboratories, LLC.
Product: Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04
Reason: Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
FDA recall #D-0663-2026 · Ongoing
Gasco Industrial Corp.
Product: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529
Reason: Subpotent drug
FDA recall #D-0669-2026 · Ongoing
QuVa Pharma, Inc.
Product: Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.
Reason: Failed Impurities/Degradation Specifications
FDA recall #D-0664-2026 · Ongoing
Blaine Labs Inc
Product: TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01
Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
FDA recall #D-0697-2026 · Ongoing
CareFusion 213, LLC
Product: BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
FDA recall #D-0643-2026 · Ongoing
Blaine Labs Inc
Product: Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid). Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc
Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
FDA recall #D-0698-2026 · Ongoing
CareFusion 213, LLC
Product: ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
FDA recall #D-0646-2026 · Ongoing
Lupin Pharmaceuticals Inc.
Product: Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01
Reason: CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
FDA recall #D-0723-2026 · Ongoing
Cipla USA, Inc.
Product: Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-410-02
Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
FDA recall #D-0661-2026 · Ongoing
Asclemed USA Inc.
Product: Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.
Reason: Lack of Assurance of Sterility
FDA recall #D-0658-2026 · Ongoing
CareFusion 213, LLC
Product: BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS.
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
FDA recall #D-0652-2026 · Ongoing
Blaine Labs Inc
Product: Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02.
Reason: Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
FDA recall #D-0692-2026 · Ongoing
SUN PHARMACEUTICAL INDUSTRIES INC
Product: Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30
Reason: Failed Impurities/Degradation Specifications
FDA recall #D-0654-2026 · Ongoing
Blaine Labs Inc
Product: TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.
Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
FDA recall #D-0694-2026 · Ongoing
CareFusion 213, LLC
Product: BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31, bulk catalog number 930480NSB
Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
FDA recall #D-0651-2026 · Ongoing
Data source: U.S. Food & Drug Administration (FDA) — openFDA enforcement API. See our methodology.