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-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
Class III (Low Risk)
Drug recall
Recall #: D-0654-2026
Fexofenadine Hydrochloride Tablets
Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Impurities/Degradation Specifications
Affected Product Description
Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot DNG0283A, exp 03/31/2027; Lots DNF0922A and DNF0923B, exp 10/31/2026
Distribution Scope
U.S. Nationwide
Class I (High Risk)
Drug recall
Recall #: D-0692-2026
Revitaderm Wound Care Gel
Manufacturer / Recalling Firm: Blaine Labs Inc
Reason for Recall: Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Affected Product Description
Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02.
Lots / Batch Codes & Expiration Dates
Lot#: BL3608, Exp. 07/01/28.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0652-2026
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) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS.
Lots / Batch Codes & Expiration Dates
Lot: 4190081, Exp 06/30/2027
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0658-2026
ACCUCAINE
Manufacturer / Recalling Firm: Asclemed USA Inc.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.
Lots / Batch Codes & Expiration Dates
Lot #: AE3102, 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 122225X4, 010626X3, 041326X4, Exp 11/30/2026; AE5052, 041426X2, 041726X1, 051826X2, Exp 04/30/2028.
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0661-2026
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, 30 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 69097-410-02
Lots / Batch Codes & Expiration Dates
Lot #: 5PB0465, 5PB0466, 5PB0557, Exp 4/30/2027; 5PB0629, 5PB0630, 5PB0633, 5PB0637, 5PB0638, Exp 6/30/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0723-2026
GLUCAGON
Manufacturer / Recalling Firm: Lupin Pharmaceuticals Inc.
Reason for Recall: CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Affected Product Description
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01
Lots / Batch Codes & Expiration Dates
Kit Lots: WB00010, Exp. Date Jan 2027; WB00017, WB00019, Exp. Date Feb 2027; WB00070, Exp. Date Jun 2027; WB00077, WB00078, Exp. Date Jul 2027; WB00130, Exp. Date Nov 2027.
Distribution Scope
Nationwide within the U.S.
Class II (Moderate Risk)
Drug recall
Recall #: D-0646-2026
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
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB
Lots / Batch Codes & Expiration Dates
Lot: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028.
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0698-2026
Fungal Fusion ERADICATION Solution
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
Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid). Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc
Lots / Batch Codes & Expiration Dates
Lot BL3572, Exp 04/16/2028
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0643-2026
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 (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.
Lots / Batch Codes & Expiration Dates
Lot: a) 3362296, expires: 12/31/2026, 4066870, expires: 02/28/2027, 4104107, expires: 03/31/2027, 4276125, expires: 09/30/2027; b) 4080695, expires: 03/31/2027, 4233300 expires: 08/31/2027.
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0697-2026
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 Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01
Lots / Batch Codes & Expiration Dates
Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall
Recall #: D-0625-2026
CHLORAPREP ONE-STEP
Manufacturer / Recalling Firm: CareFusion 213, LLC
Reason for Recall: Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Affected Product Description
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
Lots / Batch Codes & Expiration Dates
Lot # 4073005, Exp 03/31/2027
Distribution Scope
Nationwide inthe USA, as well as other foreign distribution.