FDA Enforcement Database
Drug Safety & Recalls Center
Access structured drug recall and safety information sourced directly from the U.S. Food & Drug Administration (FDA) OpenFDA Enforcement API. Stay informed on active market withdrawals, manufacturing defect notices, and drug safety advisories.
Last Synchronized
2 weeks ago
Total FDA Recalls
999
Active / Ongoing
962
Critical (Class I)
45
Medical & Legal Disclaimer: The information on this page is compiled for informational and educational reference only and does not constitute medical advice or clinical diagnosis. Never discontinue, start, or substitute any medication without consulting your prescribing doctor or a licensed pharmacist. For urgent health concerns regarding a recalled product, contact your physician immediately or report adverse events to FDA MedWatch.
Latest Critical Safety Updates (Class I)
Recent FDA enforcement reports involving serious health risk classifications
Class I
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinib...
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Ste...
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides.
Class II (Moderate Risk)
Drug recall
Recall #: D-0580-2025
DULOXETINE
Manufacturer / Recalling Firm: Breckenridge Pharmaceutical, Inc.
Reason for Recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Affected Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
Lots / Batch Codes & Expiration Dates
Lot 240539C, Exp 1/31/2027
Distribution Scope
NJ, AZ, IN
Class II (Moderate Risk)
Drug recall
Recall #: D-0578-2025
CARVEDILOL
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Affected Product Description
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05
Lots / Batch Codes & Expiration Dates
Lot#:19243202, Exp: 7/31/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0586-2025
SODIUM CHLORIDE
Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Affected Product Description
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
Lots / Batch Codes & Expiration Dates
Lot #: J5C919, Exp. 08/31/2027
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0568-2025
Duloxetine D/R
Manufacturer / Recalling Firm: Direct Rx
Reason for Recall: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Affected Product Description
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
Lots / Batch Codes & Expiration Dates
Lot #: a) 15AU2420, 01JY2407, 04OC2411, Exp 01/31/2027; 12SE2418, 24OC2424, 20NO2416, Exp 03/31/2027; 21AU2313, 21JY2311, 05JY2313, Exp Date 01/31/2026 b) 13OC2310, 05SE2304, 04AU2306, 21JY2317, 12JY2306, Exp 01/31/2026; 11JY2416, 28JU2414, 19AU2412, 02AU2409, Exp 01/31/2027; 11SE2416, 24OC2425, Exp 03/31/2027; c) 23AU2317, 21AU2314, Exp 01/31/20...
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0559-2025
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0571-2025
XOLAIR
Manufacturer / Recalling Firm: Cardinal Health Inc.
Reason for Recall: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Affected Product Description
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Lots / Batch Codes & Expiration Dates
Lot: 3617756, Expires: 12/31/2025.
Distribution Scope
Nationwide Within the U.S.
Class II (Moderate Risk)
Drug recall
Recall #: D-0557-2025
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0565-2025
Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0556-2025
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0560-2025
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0572-2025
XOLAIR
Manufacturer / Recalling Firm: Cardinal Health Inc.
Reason for Recall: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Affected Product Description
Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55
Lots / Batch Codes & Expiration Dates
Lot: 3630004, Expires: 10/31/2025.
Distribution Scope
Nationwide Within the U.S.
Class II (Moderate Risk)
Drug recall
Recall #: D-0561-2025
Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0566-2025
DOXEPIN HYDROCHLORIDE
Manufacturer / Recalling Firm: Alembic Pharmaceuticals Limited
Reason for Recall: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Affected Product Description
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31
Lots / Batch Codes & Expiration Dates
Lot: 2305015142, Exp. Date: 9/30/2025
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0558-2025
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0573-2025
RECOMBINATE
Manufacturer / Recalling Firm: Cardinal Health Inc.
Reason for Recall: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Affected Product Description
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01
Lots / Batch Codes & Expiration Dates
Lot: TRB23802AC, Expires: 03/18/2026; TRA22804AA, Expires: 10/18/2025
Distribution Scope
Nationwide Within the U.S.
Class II (Moderate Risk)
Drug recall
Recall #: D-0554-2025
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0574-2025
SPIRONOLACTONE
Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Presence of foreign substance: identified as aluminum.
Affected Product Description
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01
Lots / Batch Codes & Expiration Dates
Lot # P3314, Exp 11/30/2026
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0553-2025
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0555-2025
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0562-2025
Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA