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
9 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 I (High Risk)
Drug recall
Recall #: D-0467-2025
Male Ultra Pro
Manufacturer / Recalling Firm: SAINI TRADE INC
Reason for Recall: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Affected Product Description
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
Lots / Batch Codes & Expiration Dates
All lots Lot #: KT-1ST-43-0110/2025, Exp. 03/15/2026
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0468-2025
CEPHALEXIN
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin...
Affected Product Description
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88
Lots / Batch Codes & Expiration Dates
Lot #: 23141828, 23141829, Exp Date: 5/31/2025; 23142342, Exp Date: 6/30/2025; 23142708, Exp Date: 7/31/2025; 23144035, Exp Date: 10/31/2025; 23144270, Exp Date: 11/302025; 24140026, Exp Date: 12/31/2025
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0460-2025
CELECOXIB
Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Affected Product Description
Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
Lots / Batch Codes & Expiration Dates
Lot #47881, Exp 05/31/2026
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall
Recall #: D-0466-2025
ULTRA ARMOR
Manufacturer / Recalling Firm: SAINI TRADE INC
Reason for Recall: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
Affected Product Description
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
Lots / Batch Codes & Expiration Dates
All lots Lot #: KT-1ST-43-01-10/2025, Exp. 01/10/2027
Distribution Scope
Nationwide
Class I (High Risk)
Drug recall
Recall #: D-0488-2025
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Manufacturer / Recalling Firm: Amneal Pharmaceuticals, LLC
Reason for Recall: Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Affected Product Description
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Lots / Batch Codes & Expiration Dates
Lot #s: a) AM241019, AM241020, Exp. 06/30/2027 b) AM241019A, Exp 06/30/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0459-2025
CELECOXIB
Manufacturer / Recalling Firm: Alembic Pharmaceuticals Limited
Reason for Recall: Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Affected Product Description
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71
Lots / Batch Codes & Expiration Dates
Batch 2405014780, Exp. Date: Sep. 30, 2027
Distribution Scope
Distributed Nationwide and in PR
Class II (Moderate Risk)
Drug recall
Recall #: D-0469-2025
CEPHALEXIN
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin...
Affected Product Description
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
Lots / Batch Codes & Expiration Dates
Lot #: 23142343, Exp Date: 6/30/2025; 23143526, Exp Date: 9/30/2025; 23144036, Exp Date: 10/31/2025; 23144269, Exp Date: 11/30/2025; Lot 24140027, Exp Date: 12/31/2025; 24144282, Exp Date: 10/31/2026
Distribution Scope
Nationwide in the USA.
Class I (High Risk)
Drug recall
Recall #: D-0465-2025
ELECTRO BUZZ
Manufacturer / Recalling Firm: SAINI TRADE INC
Reason for Recall: Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Affected Product Description
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
Lots / Batch Codes & Expiration Dates
All lots Lot #: KT-1ST-43-01-07/2024, Exp. 10/15/2026
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0461-2025
CHLORTHALIDONE
Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Failed Dissolution Specifications
Affected Product Description
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15
Lots / Batch Codes & Expiration Dates
Lot # 47947, Exp 05/31/2026
Distribution Scope
Nationwide USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0497-2025
ICOSAPENT ETHYL
Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Affected Product Description
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.
Lots / Batch Codes & Expiration Dates
Lot #s: B237040, B237041, Exp 10/31/2025
Distribution Scope
IL, PA, & MS
Class II (Moderate Risk)
Drug recall
Recall #: D-0457-2025
Lacosamide Oral Solution
Manufacturer / Recalling Firm: Apotex Corp.
Reason for Recall: Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Affected Product Description
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4
Lots / Batch Codes & Expiration Dates
Batch # TZ5589, Exp Date: 01/31/2026
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0455-2025
FLUOXETINE
Manufacturer / Recalling Firm: Torrent Pharma Inc.
Reason for Recall: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Affected Product Description
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30
Lots / Batch Codes & Expiration Dates
Lot# BDX6K001; Exp. Date 06/30/2025
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0458-2025
HAND SANITIZER
Manufacturer / Recalling Firm: Consumer Product Partners, LLC
Reason for Recall: Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Affected Product Description
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 0644682, exp 2026/11/14; Lot 0644683, exp 2026/11/16
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0454-2025
INDOMETHACIN
Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: cGMP deviations
Affected Product Description
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).
Lots / Batch Codes & Expiration Dates
Lot #: 1021950, Exp. 11/30/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0456-2025
FLUOXETINE
Manufacturer / Recalling Firm: Torrent Pharma Inc.
Reason for Recall: CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Affected Product Description
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)
Lots / Batch Codes & Expiration Dates
Lot# BDX6K001; Exp. Date: 06/30/2025
Distribution Scope
U.S. Nationwide.
Class I (High Risk)
Drug recall
Recall #: D-0453-2025
ENDURANCE BOOST WITH HORNY GOAT WEED
Manufacturer / Recalling Firm: EnShiShiXiangNiShangMaoYouXianGongSi
Reason for Recall: Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Affected Product Description
ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N
Lots / Batch Codes & Expiration Dates
Lot: 250214PRO, Expiration Date: 02/14/2027.
Distribution Scope
Nationwide Via Amazon Platform
Class II (Moderate Risk)
Drug recall
Recall #: D-0447-2025
BROMFENAC OPHTHALMIC SOLUTION 0.09%
Manufacturer / Recalling Firm: Alembic Pharmaceuticals Limited
Reason for Recall: Failed Impurities/Degradation Specifications
Affected Product Description
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17
Lots / Batch Codes & Expiration Dates
Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
Distribution Scope
US Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0449-2025
CARVEDILOL
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Affected Product Description
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Lots / Batch Codes & Expiration Dates
[100-Count Bottles] Lot 19231618, exp Mar-25; 19232064, exp Apr-25; 19232324, May-25; 19233369, Exp Jul-25; Lot 19234162, Exp Sep-25; Lot 19240543, Exp Jan-26 [500-Count Bottles] Lots 19231174, 19231199, 19231164, Exp Feb-25, 19231517,19231527, 19231566,19231568,19231595, 19231618,19231634,19231638, 19231448, Exp Mar-25, 19232043,19232051,1...
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0448-2025
CARVEDILOL
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Affected Product Description
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Lots / Batch Codes & Expiration Dates
[100-Count Bottles] Lot 19231450, Exp Mar-25, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lot 19240280, Exp DEC-25 [500-Count Bottles] Lot 19231450, 19231464, 19231471, 19231493, Exp Mar-25, 19232083, 19232103 Exp Apr-25, 19232658, Exp Jun-25; Lot 19233328, 19233343, 19233344, 19233345, Exp Jul-25; Lot 19234275, Exp Sep-25; Lots 19234843,...
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0452-2025
THEOPHYLLINE
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: OOS results reported for the Dissolution (by UV) test.
Affected Product Description
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01
Lots / Batch Codes & Expiration Dates
Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26
Distribution Scope
Nationwide in the USA