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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
Data Provenance & Source Transparency: All drug recall records displayed are retrieved directly from the official U.S. FDA OpenFDA Enforcement API. Questo organizes and presents this data for medical education and research without modifying original regulatory facts. Explore OpenFDA API Documentation →
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
THYROID
Superpotent Drug
VITRUVIAS THERAPEUTICS INC Sep 23, 2026
Class I
NYSTATIN
Failed Stability Specifications
SUN PHARMACEUTICAL INDUSTRIES... Sep 23, 2026
Class I
SODIUM CHLORIDE
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic mat...
B BRAUN MEDICAL INC Sep 16, 2026
Showing 221–240 of 1,170 factual FDA recall reports
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
FDA Report: Jul 08, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
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
FDA Report: Jul 08, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
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
FDA Report: Jul 08, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
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
FDA Report: Jul 08, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
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).
FDA Report: Jul 08, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
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.
FDA Report: Jul 08, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
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
FDA Report: Jul 08, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
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
FDA Report: Jul 08, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
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
FDA Report: Jul 08, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
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
FDA Report: Jul 08, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
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.
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
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.
Class II (Moderate Risk)
Drug recall Recall #: D-0613-2026

SENSIPAR

Manufacturer / Recalling Firm: Amgen, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
Lots / Batch Codes & Expiration Dates
Lot#: 1156858, Exp. Date 12/31/2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0616-2026

SENSIPAR

Manufacturer / Recalling Firm: Amgen, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30
Lots / Batch Codes & Expiration Dates
Lot #: 1157056, Exp. Date 02/29/2028
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0628-2026

PERAMPANEL

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6
Lots / Batch Codes & Expiration Dates
Lot AE01763, Expires 9/30/2027.
Distribution Scope
Nationwide in the USA
Class III (Low Risk)
Drug recall Recall #: D-0619-2026

HYDROXYZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: ANI Pharmaceuticals, Inc.
Reason for Recall: Presence of foreign substance
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10
Lots / Batch Codes & Expiration Dates
Lot S25133A
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall Recall #: D-0624-2026

CHLORAPREP ONE-STEP

Manufacturer / Recalling Firm: CareFusion 213, LLC
Reason for Recall: Non-Sterility: Due to presence of Aspergillus penicillioides.
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.
Lots / Batch Codes & Expiration Dates
Lot # 4032183, Exp 01/31/2027
Distribution Scope
Nationwide inthe USA, as well as other foreign distribution.
Class II (Moderate Risk)
Drug recall Recall #: D-0621-2026

PReye Vitamin See Antioxidant Preservative Free Eye Drops

Manufacturer / Recalling Firm: PReye LLC
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO
Lots / Batch Codes & Expiration Dates
All lots within expiry
Distribution Scope
CO
Class II (Moderate Risk)
Drug recall Recall #: D-0609-2026

METHYLERGONOVINE MALEATE

Manufacturer / Recalling Firm: The Harvard Drug Group LLC
Reason for Recall: Subpotent Drug
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonovine Maleate Tablets, 0.2 mg, USP, One Tablet, Major Pharm/Indianapolis, IN 46268, NDC 0904-7282-10.
Lots / Batch Codes & Expiration Dates
Lots: N02327, expires: 09/2026; N02740, expires: 12/2026; N03069, expires: 08/2027.
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0618-2026

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag

Manufacturer / Recalling Firm: Central Admixture Pharmacy Services, Inc.
Reason for Recall: Incorrect product formulation: bag did not contain copper and famotidine per label.
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767.
Lots / Batch Codes & Expiration Dates
24-1269856-0-1
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall Recall #: D-0623-2026

CHLORAPREP ONE-STEP

Manufacturer / Recalling Firm: CareFusion 213, LLC
Reason for Recall: Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
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 # 3143780, 3151595, 3152898, 3152906, 3157235, 3158139, 3159803, 3166919, 3167620, 3191056, Exp Date: 05/31/2026; Lot # 3171115, 3172853, 3177820, 3193968, 3194750, 3199123, 3201195, 3206618, 3212202, 3213819, 3214876, Exp Date: 06/30/2026; Lot # 3222170, 3226846, 3228153, 3229867, 3228293, 3243337, Exp Date: 07/31/2026; Lot # 3230424, 3234042,...
Distribution Scope
Nationwide inthe USA, as well as other foreign distribution.

FDA Recall Classes & Health Hazard Definitions

Official regulatory classifications defined by the U.S. Food & Drug Administration (21 CFR Part 7)

FDA Health Hazard Classifications
Class I — High Risk Severity

Class I Recall

Regulatory Definition: A situation in which there is a reasonable probability that exposure to a recalled product will cause serious adverse health consequences or death.

Examples: Microbial contamination of sterile injectables, presence of unlabelled severe allergens, toxic impurities, or dosage potency errors.
Class II — Moderate Risk Severity

Class II Recall

Regulatory Definition: A situation in which exposure to a recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote.

Examples: Sub-potent non-life-sustaining tablets, minor dissolution rate variations, or outer carton label misprints.
Class III — Low Risk Severity

Class III Recall

Regulatory Definition: A situation in which exposure to a recalled product is not likely to cause adverse health consequences, but violates FDA packaging or manufacturing regulations.

Examples: Minor packaging flaws, harmless tablet color variances, or minor typographical errors in package inserts.
Enforcement Action Statuses
Ongoing Action

Ongoing Status

The recall action is actively in progress across supply chains, distributors, healthcare facilities, and retail pharmacies nationwide.

Completed / Terminated

Completed & Terminated Status

The FDA has confirmed that all reasonable efforts have been made to remove or correct the product, and the enforcement file is officially closed.

System Notice

Confirm Action