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
11 hours ago
Total FDA Recalls
1,170
Active / Ongoing
1,133
Critical (Class I)
63
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 III (Low Risk)
Drug recall
Recall #: D-0671-2025
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Manufacturer / Recalling Firm: Granules Pharmaceuticals Inc.
Reason for Recall: Failed Impurities/Degradation Specifications:
Affected Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-031-01
Lots / Batch Codes & Expiration Dates
Lot#: GPC250178A, Exp Date: 06-22-2027
Distribution Scope
Distributed Nationwide in the USA
Class III (Low Risk)
Drug recall
Recall #: D-0669-2025
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Manufacturer / Recalling Firm: Granules Pharmaceuticals Inc.
Reason for Recall: Failed Impurities/Degradation Specifications:
Affected Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-029-01
Lots / Batch Codes & Expiration Dates
Lot#: GPC250158A, Exp Date: 06-22-2027
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0666-2025
mel rx Skin
Manufacturer / Recalling Firm: Private Label Skin Care Inc.
Reason for Recall: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Affected Product Description
mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Skin Rx Beverly Hills, CA 90210
Lots / Batch Codes & Expiration Dates
Lot # 58170A and 58172A, Exp Date: 09/2025
Distribution Scope
CA, GA only
Class III (Low Risk)
Drug recall
Recall #: D-0670-2025
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Manufacturer / Recalling Firm: Granules Pharmaceuticals Inc.
Reason for Recall: Failed Impurities/Degradation Specifications:
Affected Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-030-01
Lots / Batch Codes & Expiration Dates
lot#: GPC250159A, Exp Date: 06-22-2027
Distribution Scope
Distributed Nationwide in the USA
Class III (Low Risk)
Drug recall
Recall #: D-0672-2025
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Manufacturer / Recalling Firm: Granules Pharmaceuticals Inc.
Reason for Recall: Failed Impurities/Degradation Specifications:
Affected Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 20 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-032-01
Lots / Batch Codes & Expiration Dates
Lot#: GPC250179A, Exp Date: 06-22-2027
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0663-2025
ARTISAN OF SKIN
Manufacturer / Recalling Firm: Private Label Skin Care Inc.
Reason for Recall: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Affected Product Description
ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210
Lots / Batch Codes & Expiration Dates
Lot # 58170A and 58172A, Exp Date: 09/2025
Distribution Scope
CA, GA only
Class III (Low Risk)
Drug recall
Recall #: D-0660-2025
70% ISOPROPYL RUBBING ALCOHOL
Manufacturer / Recalling Firm: Consumer Product Partners, LLC
Reason for Recall: Cross Contamination with Other Products.
Affected Product Description
Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 30142-810-14
Lots / Batch Codes & Expiration Dates
Lot 0662036; Exp. Date 06/19/2027
Distribution Scope
US Nationwide.
Class III (Low Risk)
Drug recall
Recall #: D-0661-2025
70% ISOPROPYL RUBBING ALCOHOL
Manufacturer / Recalling Firm: Consumer Product Partners, LLC
Reason for Recall: Cross Contamination with Other Products.
Affected Product Description
TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can, Distributed By The KROGER CO., Cincinnati, Ohio 45202. NDC: 36800-589-14
Lots / Batch Codes & Expiration Dates
Lot 0662036; Exp Date 06/19/2027
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0668-2025
edunn clarity
Manufacturer / Recalling Firm: Private Label Skin Care Inc.
Reason for Recall: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Affected Product Description
edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.
Lots / Batch Codes & Expiration Dates
Lot # 58170A and 58172A, Exp Date: 09/2025
Distribution Scope
CA, GA only
Class II (Moderate Risk)
Drug recall
Recall #: D-0662-2025
AZELAIC ACID
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations: Market complaints received for gritty texture (grainy)
Affected Product Description
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52
Lots / Batch Codes & Expiration Dates
Batch # 19252524, Exp Date: May 2027
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0654-2025
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Manufacturer / Recalling Firm: Northwind Pharmaceuticals LLC
Reason for Recall: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was de...
Affected Product Description
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Lots / Batch Codes & Expiration Dates
Lot #: a) F118062503, Exp Date 05/31/2027, F118062507, Exp Date. 07/31/2027. b) F118062504, F118062505, Exp. Date 05/31/2027; F118062509, Exp. Date. 08/31/2027; F118062512, Exp. Date 04/30/2027. c) F118062506, Exp. Date 06/30/2027. d) F118062423, Exp. Date 01/31/2027; F118062501, Exp. Date 06/30/2027; F118062502, Exp. Date 04/30/2027; F118062508, E...
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0651-2025
CYCLOPHOSPHAMIDE
Manufacturer / Recalling Firm: Sandoz Inc
Reason for Recall: cGMP deviations: Temperature excursion during transportation.
Affected Product Description
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10.
Lots / Batch Codes & Expiration Dates
Only the following 6 GTN Numbers for Lot # 110459 exp. date 02/28/2027: (01)00307813528104(21)10686040629319 (01)00307813528104(21)10687281435306 (01)00307813528104(21)10687409963168 (01)00307813528104(21)10701200331212 (01)00307813528104(21)10687325644911 (01)00307813528104(21)10687661160169
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0656-2025
ENTECAVIR
Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed Impurity/Degradation Specifications
Affected Product Description
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Lots / Batch Codes & Expiration Dates
Lot E309376; Exp 11/30/2025
Distribution Scope
U.S. Nationwide
Class I (High Risk)
Drug recall
Recall #: D-0655-2025
CYCLOBENZAPRINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Unichem Pharmaceuticals USA Inc.
Reason for Recall: Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Affected Product Description
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.
Lots / Batch Codes & Expiration Dates
Lot No: GMML24026A, Expires: 09/30/2027
Distribution Scope
Nationwide within the U.S.A
Class II (Moderate Risk)
Drug recall
Recall #: D-0647-2025
CHLORPROMAZINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any table...
Affected Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Lots / Batch Codes & Expiration Dates
Lot: a)1020919, 1021133, Exp 09/30/2026; 1021447, Exp 10/31/2026; 1021741, 1022202, Exp 11/30/2026; 1022474, Exp 12/31/2026 Lot: b) 1020460, exp 08/31/2026; 1022417, exp 12/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0658-2025
KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE
Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
Affected Product Description
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
Lots / Batch Codes & Expiration Dates
Lot# AD70995; Exp 10/31/2025
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0645-2025
ARIPIPRAZOLE
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Superpotent drug
Affected Product Description
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03
Lots / Batch Codes & Expiration Dates
Lot #: 24144162, Exp. Date 09/2027
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0649-2025
CHLORPROMAZINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any table...
Affected Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)
Lots / Batch Codes & Expiration Dates
Lot: 1021652, Exp 10/31/2026; 1022539, Exp 01/31/2027; 1023666, Exp 03/31/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0652-2025
STERILE WATER
Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Affected Product Description
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Lots / Batch Codes & Expiration Dates
Lot #: J3L519, J3L528, Exp.: 31AUG2026 Lot #: J4C522, J4C523, Exp.:28FEB2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0653-2025
SODIUM CHLORIDE FOR IRRIGATION
Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
Affected Product Description
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
Lots / Batch Codes & Expiration Dates
Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027.
Distribution Scope
U.S. Nationwide