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-0668-2026
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Manufacturer / Recalling Firm: Gasco Industrial Corp.
Reason for Recall: Subpotent drug
Affected Product Description
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924
Lots / Batch Codes & Expiration Dates
Lots 250221A5, 250224A2 within expiry
Distribution Scope
Nationwide within the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0665-2026
Gasco Isopropyl Alcohol 70%
Manufacturer / Recalling Firm: Gasco Industrial Corp.
Reason for Recall: Subpotent drug
Affected Product Description
Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3
Lots / Batch Codes & Expiration Dates
Lot 250306B3, within expiry
Distribution Scope
Nationwide within the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0672-2026
Pemetrexed for Injection 500mg/Vial
Manufacturer / Recalling Firm: Reliance Life Sciences Private Limited
Reason for Recall: Lack of Sterility Assurance
Affected Product Description
Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01
Lots / Batch Codes & Expiration Dates
Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028;
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0691-2026
Clomiphene Citrate USP Active Pharmaceutical Ingredient
Manufacturer / Recalling Firm: Shimoga Chemicals
Reason for Recall: cGMP deviations
Affected Product Description
Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Kupwad Samgli, Maharashtra, 416436, India.
Lots / Batch Codes & Expiration Dates
Lot #: a) CC/004/24-25, Exp Date September 2029; CC0032526, Exp. Date August 2030 b) CC0442526, Exp. Date Aug 2030; CC/005/24-25, Exp. Date November 2029 c) CC0032526, Exp. Date August 2030; CC/009/24-25, Exp. Date January 2030;CC/005/24-25, Exp. Date November 2029.
Distribution Scope
CA & FL only
Class II (Moderate Risk)
Drug recall
Recall #: D-0670-2026
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Manufacturer / Recalling Firm: Gasco Industrial Corp.
Reason for Recall: Subpotent drug
Affected Product Description
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.
Lots / Batch Codes & Expiration Dates
Lots 250206B1, 250218B2, 250507B1, within expiry
Distribution Scope
Nationwide within the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0667-2026
Gasco Isopropyl Alcohol 70%
Manufacturer / Recalling Firm: Gasco Industrial Corp.
Reason for Recall: Subpotent drug
Affected Product Description
Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.
Lots / Batch Codes & Expiration Dates
Lot 250218B3, within expiry
Distribution Scope
Nationwide within the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0666-2026
Gasco Isopropyl Alcohol 70%
Manufacturer / Recalling Firm: Gasco Industrial Corp.
Reason for Recall: Subpotent drug
Affected Product Description
Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA
Lots / Batch Codes & Expiration Dates
Lots 250108A2, 250109A1, 250115A1, 250124A1, 250213A1, 250220Z3, 250221A3, 250221A4, 250224A1, 250303A3, 250306A1, 250307A1, within expiry
Distribution Scope
Nationwide within the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0662-2026
METHOHEXITAL SODIUM
Manufacturer / Recalling Firm: ONESOURCE SPECIALTY PHARMA LIMITED
Reason for Recall: Failed Impurities/Degradation Specifications
Affected Product Description
Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-893-31
Lots / Batch Codes & Expiration Dates
Lot #: 7000612A, Exp. Date 1/2028
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0657-2026
Synjardy XR Tablets
Manufacturer / Recalling Firm: Boehringer Ingelheim Pharmaceuticals, Inc.
Reason for Recall: CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Affected Product Description
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 00597-0300-45
Lots / Batch Codes & Expiration Dates
Lot 3244413; Exp. 12/31/2028
Distribution Scope
OH
Class II (Moderate Risk)
Drug recall
Recall #: D-0660-2026
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Manufacturer / Recalling Firm: Lannett Company Inc.
Reason for Recall: Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Affected Product Description
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC: 0527-0790-37.
Lots / Batch Codes & Expiration Dates
Lot#: 25285401A, Exp. Date: 04/2027
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0645-2026
CHLORAPREP ONE-STEP
Manufacturer / Recalling Firm: CareFusion 213, LLC
Reason for Recall: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Affected Product Description
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Lots / Batch Codes & Expiration Dates
Lot: (a) 3214024, 3199359, 3200136, Exp 6/30/2026, 3212372, Exp. 7/31/2026, 3237018, 3243267, 3264290, Exp. 8/31/2026, 3313291, Exp. 10/31/2026, 3334121, Exp. 11/30/2026, 4030693, 4033380, Exp 1/31/2027, 4058103, 4065931, Exp. 2/28/2027, 4093245, 4094302, Exp. 3/31/2027, 4145548, 4146564, Exp. 5/31/2027, 4191049, Exp 6/30/2027, 4214794, 4218807,...
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0648-2026
CHLORAPREP ONE-STEP
Manufacturer / Recalling Firm: CareFusion 213, LLC
Reason for Recall: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Affected Product Description
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, bulk catalog number 930815NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Lots / Batch Codes & Expiration Dates
Lot: a) 3291614, Exp 10/31/2026, 4034080, 4036599, Exp 01/31/2027, 4081350, Exp 03/31/2027, 5008234, Exp 12/31/2027. b) 2320053, Exp 11/30/2025, 4151258, Exp 05/31/2027. 5084224, Exp 03/31/2028.
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0649-2026
CHLORAPREP ONE-STEP
Manufacturer / Recalling Firm: CareFusion 213, LLC
Reason for Recall: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Affected Product Description
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, bulk catalog number 930725NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Lots / Batch Codes & Expiration Dates
Lot: a) 4157798, Exp 05/31/2027, 5016842, Exp 12/31/2027, 5112542, Exp 04/30/2028 b) 3330777, Exp 10/31/2026, 3345111, Exp 12/31/2026, 4037991, Exp 01/31/2027, 4114505, Exp 04/30/2027, 4156664, Exp 05/31/2027, 4270441, Exp 09/30/2027, 5078395, Exp 03/31/2028
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0714-2026
GEMCITABINE
Manufacturer / Recalling Firm: McKesson
Reason for Recall: Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Affected Product Description
Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hikma, Berkeley Heights, NJ 07922. NDC: 0143-9341-01
Lots / Batch Codes & Expiration Dates
Lot #: CB0046, Exp. Date 06/2027
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0647-2026
CHLORAPREP ONE-STEP
Manufacturer / Recalling Firm: CareFusion 213, LLC
Reason for Recall: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Affected Product Description
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Lots / Batch Codes & Expiration Dates
Lot: a) 3194046, Exp. 06/30/2026, 3217036, Exp 07/31/2026, 3279434, Exp 09/30/2026, 3286268, 3304460, Exp 10/31/2026, 3346277, Exp 11/30/2026, 4031686, 4039656, Exp 01/31/2027, 4048949, 4060437, 4067207, Exp 02/28/2027, 4092773, 4094978, 4106623, Exp 03/31/2027, 4120371, 4129596, Exp 04/30/2027, 4144918, Exp 05/31/2027, 4193623 4200771, Exp 06/3...
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0695-2026
TERPENICOL
Manufacturer / Recalling Firm: Blaine Labs Inc
Reason for Recall: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Affected Product Description
TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01.
Lots / Batch Codes & Expiration Dates
Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0693-2026
TRIDERGEL
Manufacturer / Recalling Firm: Blaine Labs Inc
Reason for Recall: CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Affected Product Description
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01.
Lots / Batch Codes & Expiration Dates
Lot #: BL3435, Exp. 11/06/26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0653-2026
IMULDOSA
Manufacturer / Recalling Firm: ACCORD BIOPHARMA INC
Reason for Recall: Lack of assurance of Sterility:
Affected Product Description
IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.
Lots / Batch Codes & Expiration Dates
Lot # 004L24A, Exp Date: 02/19/2027.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0659-2026
LIDOCAINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Asclemed USA Inc.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01.
Lots / Batch Codes & Expiration Dates
Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028.
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0696-2026
vite20 Antifungal Cream
Manufacturer / Recalling Firm: Blaine Labs Inc
Reason for Recall: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Affected Product Description
vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.
Lots / Batch Codes & Expiration Dates
Lot BL3462, Exp. 2/7/2027
Distribution Scope
Nationwide in the USA