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
10 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 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
Class II (Moderate Risk)
Drug recall
Recall #: D-0675-2026
CINACALCET
Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Affected Product Description
Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-411-02
Lots / Batch Codes & Expiration Dates
Lot #: 5PB0165, 5PB0166, Exp 1/31/2027; 5PB0552, Exp 4/30/2027; 5PB0642, 5PB0643, 5PB0644, Exp 6/30/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0676-2026
CINACALCET
Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Affected Product Description
Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-412-02
Lots / Batch Codes & Expiration Dates
Lot #: 5PB0563, Exp 4/30/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0644-2026
PURPREP
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 PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.
Lots / Batch Codes & Expiration Dates
Lot: 4298581, expires: 09/30/2026.
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0656-2026
LEVOTHYROXINE SODIUM
Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug
Affected Product Description
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-458-15.
Lots / Batch Codes & Expiration Dates
Lot # D2401522, Exp Date: 06/2026.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0650-2026
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) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54365-400-39, bulk catalog number 930825NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Lots / Batch Codes & Expiration Dates
Lot: a) 3352149, Exp 12/31/2026 b) 5028798, Exp 01/31/2028, 5069651, Exp 03/31/2028.
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0699-2026
REVITADERM WOUND CARE
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
Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,
Lots / Batch Codes & Expiration Dates
Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0655-2026
PREDNISOLONE ACETATE
Manufacturer / Recalling Firm: Lupin Pharmaceuticals Inc.
Reason for Recall: Presence of Foreign Substance
Affected Product Description
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA
Lots / Batch Codes & Expiration Dates
Lots: a) HA00937, HA00939, HA00941, HA00971, H00973, HA00975, Expires: 7/31/2026; HA00987, HA00989, HA00991, HA01010, HA01012, HA01014, HA01016, HA01048, Expires: 8/31/2026; HA01120, HA01137, HA01129, HA01138, HA01133, Expires: 9/30/2026; HA01148, HA01196, HA01198, HA01200, HA01206, HA01208, HA01210, HA01212, HA01214, HA01216, HA01218, HA01220, Ex...
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0651-2026
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),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-31, bulk catalog number 930480NSB
Lots / Batch Codes & Expiration Dates
Lot: 4088933, Exp 03/31/2027, 4177711, 4195438, Exp 06/30/2027, 5051114, Exp 02/29/2028, 5070540, Exp 03/31/2028, 5106254, Exp 04/30/2028, 5141607, Exp 05/31/2028, 5196494, Exp 07/31/2028.
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0694-2026
TRIPENICOL S
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
TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.
Lots / Batch Codes & Expiration Dates
Lot #BL3411R, Exp 6/8/2027
Distribution Scope
Nationwide in the USA