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-0601-2025
CURAD ALCOHOL PREP PADS
Manufacturer / Recalling Firm: MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Affected Product Description
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30
Lots / Batch Codes & Expiration Dates
61224050002
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0604-2025
GOOD NEIGHBOR PHARMACY ALCOHOL ANTISEPTIC SKIN CLEANSER
Manufacturer / Recalling Firm: MEDLINE INDUSTRIES, LP - Northfield
Reason for Recall: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Affected Product Description
Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen, 1 West First Avenue, Conshohocken, PA 19428, Made in China: 100 eaches per box, 30 boxes per case, (3,000 eaches per case), NDC 46122-043-78.
Lots / Batch Codes & Expiration Dates
61224070074
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0589-2025
BZK Antiseptic Towelette
Manufacturer / Recalling Firm: Taizhou Kangping Medical Science And Technology Co., Ltd.
Reason for Recall: Lack of Assurance of Sterility.
Affected Product Description
BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01
Lots / Batch Codes & Expiration Dates
Lot Numbers: 220583459, 230553459, 232743459, 110523, 031524, 052224, 247793459
Distribution Scope
NY
Class II (Moderate Risk)
Drug recall
Recall #: D-0594-2025
CARVEDILOL
Manufacturer / Recalling Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Reason for Recall: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Affected Product Description
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61
Lots / Batch Codes & Expiration Dates
Lot #: T05693, Exp. Date 03/2026
Distribution Scope
Product was distributed nationwide within the United States.
Class II (Moderate Risk)
Drug recall
Recall #: D-0595-2025
TAVABOROLE
Manufacturer / Recalling Firm: VIONA PHARMACEUTICALS INC
Reason for Recall: Discoloration
Affected Product Description
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04
Lots / Batch Codes & Expiration Dates
Lot #: T401968
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0591-2025
SODIUM BICARBONATE
Manufacturer / Recalling Firm: PFIZER INC
Reason for Recall: Lack of Assurance of Sterility.
Affected Product Description
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.
Lots / Batch Codes & Expiration Dates
Lot #: LH2671, Exp. 11/30/2026
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0590-2025
Vial Label: Epinephrine Injection
Manufacturer / Recalling Firm: PFIZER INC
Reason for Recall: Lack of Assurance of Sterility.
Affected Product Description
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.
Lots / Batch Codes & Expiration Dates
Lot #: LY3681, LY4360, LY4416, Exp. 02/28/2026
Distribution Scope
U.S. Nationwide
Class III (Low Risk)
Drug recall
Recall #: D-0593-2025
ALBUTEROL SULFATE
Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Affected Product Description
Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.
Lots / Batch Codes & Expiration Dates
Lot#: 4IB0519, Exp. 04/30/2026
Distribution Scope
U.S. Nationwide.
Class III (Low Risk)
Drug recall
Recall #: D-0592-2025
Sensodyne PRONAMEL
Manufacturer / Recalling Firm: Haleon US Holdings LLC
Reason for Recall: Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Affected Product Description
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2
Lots / Batch Codes & Expiration Dates
Lot # for Case: 5058RB, Exp. date: 08/31/2027 Lot # for Carton and Tube: NJ2A, Exp 08/31/2027
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0584-2025
BELSOMRA
Manufacturer / Recalling Firm: Merck & Co. Inc
Reason for Recall: Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Affected Product Description
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label)
Lots / Batch Codes & Expiration Dates
Lots 2090019 and 2123744, Exp. 4/30/2027
Distribution Scope
Nationwide in the USA and PR.
Class II (Moderate Risk)
Drug recall
Recall #: D-0579-2025
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, 25 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 68462-165-05
Lots / Batch Codes & Expiration Dates
Lot#:19243104, Expires: 7/31/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0581-2025
METOPROLOL TARTRATE
Manufacturer / Recalling Firm: Westminster Pharmaceuticals LLC
Reason for Recall: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Affected Product Description
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10
Lots / Batch Codes & Expiration Dates
Batch # R55230021, R55230031, R55230041, Exp Date: 9/30/25; Batch # R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131, R55230141, Exp Date: 10/31/2025; Batch # R55230151, Exp Date: 11/30/25; Batch # R55240011, Exp Date: 12/31/25; Batch # R55240021, R55240031, R55240041, R55240051, R55240061, Exp Date:...
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0582-2025
METOPROLOL TARTRATE
Manufacturer / Recalling Firm: Westminster Pharmaceuticals LLC
Reason for Recall: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Affected Product Description
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
Lots / Batch Codes & Expiration Dates
Batch # R56240011, Exp Date: 2/28/26; Batch # R56240021, R56240031, Exp Date: 3/31/26; Batch # R56240041, R56240051, R56240061, Exp Date: 4/30/26; Batch # R56240071, Exp Date: 7/31/26
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0575-2025
LEVOXYL
Manufacturer / Recalling Firm: Pfizer
Reason for Recall: Subpotent drug
Affected Product Description
Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Austria, NDC 60793-851-01.
Lots / Batch Codes & Expiration Dates
Lot #: 24C11, Exp 2/28/2026.
Distribution Scope
Within U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0577-2025
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, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
Lots / Batch Codes & Expiration Dates
Lot#: a)19242274, 19242275, 19242272, Exp: 5/31/20; b) 19242272, Exp: 5/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0583-2025
THEOPHYLLINE
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do...
Affected Product Description
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
Lots / Batch Codes & Expiration Dates
Batch # 19243193, 19243215, 19243231,19243248, 19243283, Exp 7/31/2026; 19244530, 19244561, Exp 10/31/2026; 19250178, Exp 12/31/2026
Distribution Scope
USA nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0576-2025
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Dissolution Specifications: low dissolution results
Affected Product Description
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
Lots / Batch Codes & Expiration Dates
Lot 23121560, Exp 4/30/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0587-2025
CARVEDILOL
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Affected Product Description
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05
Lots / Batch Codes & Expiration Dates
Lot #: 17241257, 17241258, 17241279, Exp. Date 06/2026
Distribution Scope
Nationwide within the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0585-2025
LACTATED RINGERS
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
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.
Lots / Batch Codes & Expiration Dates
Lot #: J5C802, J5C917, J5C918, Exp. 08/31/2027
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0588-2025
CARVEDILOL
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Affected Product Description
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05
Lots / Batch Codes & Expiration Dates
Lot #: 17241213, 17241215, 17241224, Exp. Date 06/2026
Distribution Scope
Nationwide within the USA