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-0002-2026
ENTECAVIR
Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Affected Product Description
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Lots / Batch Codes & Expiration Dates
Lot#: E409309, Exp 12/31/2026
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0676-2025
BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION
Manufacturer / Recalling Firm: Apotex Corp.
Reason for Recall: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Affected Product Description
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).
Lots / Batch Codes & Expiration Dates
a) lot # VE0614 exp. date 12/2025 UPC:(01)00360505058914 (5 mL) b) lot # VE0616 exp. date 12/2025 UPC:(01)0(03)60505058921 (10 mL)
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0001-2026
ENTECAVIR
Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Affected Product Description
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, 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#: E409308, Exp 12/31/2026
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0659-2025
Quick Touch Alcohol Prep Pads
Manufacturer / Recalling Firm: YANGZHOU YULOU PAPER PRODUCTS CO., LTD
Reason for Recall: cGMP Deviations
Affected Product Description
Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.
Lots / Batch Codes & Expiration Dates
Lot #: 20240610, Exp. Date 06/2029
Distribution Scope
N/A
Class III (Low Risk)
Drug recall
Recall #: D-0673-2025
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), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01
Lots / Batch Codes & Expiration Dates
Lot#: GPC250181A, Exp Date: 06-19-2027
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0665-2025
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10%
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
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com
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-0664-2025
Skin MD by Dr Monika Kiripolsky
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
Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211
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-0674-2025
POVIDONE-IODINE
Manufacturer / Recalling Firm: Medline Industries, LP
Reason for Recall: Subpotent drug
Affected Product Description
READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic, Not Sterile, 1 Gallon (3.78 L) per bottle, Manufactured in USA by Medline Industries, LP., Three Lakes Drive, Northfield, IL 60093, NDC 53329-939-25
Lots / Batch Codes & Expiration Dates
Lot # 24EJA180, Exp 06/01/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0667-2025
Micronized BPO Gel Cleanser 10%
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
Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 g), University Skin Institute, 650 University Ave, Ste 200, Sacramento, CA 95825.
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-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