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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
2 weeks ago
Total FDA Recalls
999
Active / Ongoing
962
Critical (Class I)
45
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
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinib...
Blaine Labs Inc Jul 08, 2026
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Ste...
CareFusion 213, LLC Jul 01, 2026
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides.
CareFusion 213, LLC Jul 01, 2026
Showing 61–80 of 999 factual FDA recall reports
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.
Class II (Moderate Risk)
Drug recall Recall #: D-0617-2026

DULOXETINE D/R

Manufacturer / Recalling Firm: Direct Rx
Reason for Recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.
Lots / Batch Codes & Expiration Dates
Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0627-2026

POVI-ONE

Manufacturer / Recalling Firm: Elevate Oral Care
Reason for Recall: sub potency
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.
Lots / Batch Codes & Expiration Dates
Lots PO062402, Exp Date 6/30/2026, PO072401, Exp Date 7/30/2026, PO092401, Exp Date 9/30/2026, PO102401, Exp Date 10/31/2026 & PO102402, Exp Date 10/31/2026.
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0614-2026

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, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30
Lots / Batch Codes & Expiration Dates
Lot #: 1157055, Exp. Date 1/31/2028
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0611-2026

FENOFIBRATE

Manufacturer / Recalling Firm: Ajanta Pharma USA Inc
Reason for Recall: CGMP Deviations
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04.
Lots / Batch Codes & Expiration Dates
Lot # PA02216; Exp. 12/2029
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0622-2026

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 Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, 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 # 3201277, Exp Date: 06/30/2026; Lot # 3213912, 3214206, 3214914, 3215710, 3227485, Exp Date: 07/31/2026; Lot # 3234036, 3234037, 3236460, 3237244, 3243095, 3263576, 3263580, 3264318, Exp Date: 08/31/2026; Lot # 3266655, 3266657, 3270586, 3278714, 3279949, 3282215, 3282956, Exp Date: 09/30/2026; Lot # 3299094, 3299684, 3302529, 3301463, 330983...
Distribution Scope
Nationwide inthe USA, as well as other foreign distribution.
Class II (Moderate Risk)
Drug recall Recall #: D-0612-2026

CORLANOR

Manufacturer / Recalling Firm: Amgen, 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
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy.
Lots / Batch Codes & Expiration Dates
a) Lot # 1138901, Exp. Date 08/31/2026; 1149846, Exp. Date 04/30/2027 b) Lot #1138201, 1138202, 08/31/2026, 1138900, 1141143, Exp. Date 08/31/2026; 1140280, 1140281, 1142063, Exp. Date 10/31/2026; 1142062, 1142942, 1142943, Exp. Date 11/30/2026; 1144081, 1144104, Exp. Date 12/31/2026; 1146373, 1146374, Exp. Date 01/31/2027; 1147491, 1147492, 11498...
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0615-2026

CORLANOR

Manufacturer / Recalling Firm: Amgen, 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
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
Lots / Batch Codes & Expiration Dates
Lot #: 1138203, 1142065, Exp. Date 07/31/2026; 1145151, 1145152, 1145153, Exp. Date 2/28/2027; 1148908, 1148909, Exp. Date 05/31/2027; 1162845, 1162846, Exp. Date 11/30/2027; 1166471, 1166472, 1166473, Exp. Date 05/31/2028; 1170615, Exp. Date 08/31/2028
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0626-2026

LACOSAMIDE

Manufacturer / Recalling Firm: Annora Pharma Private Limited
Reason for Recall: Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
FDA Report: Jul 01, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60.
Lots / Batch Codes & Expiration Dates
Lot: A253999, A254000, Expires: 09/30/2027.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0635-2026

Med Pride

Manufacturer / Recalling Firm: Dabur India Limited
Reason for Recall: CGMP Deviations; deficiencies observed during FDA inspection
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4.
Lots / Batch Codes & Expiration Dates
Lot# 007, 008, 009, 015, 016, Within Expiry.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0634-2026

Cura Hongos

Manufacturer / Recalling Firm: Dabur India Limited
Reason for Recall: CGMP Deviations; deficiencies observed during FDA inspection
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.
Lots / Batch Codes & Expiration Dates
Lot# 0003, within expiry
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0592-2026

VistaPharm

Manufacturer / Recalling Firm: PAI Holdings LLC
Reason for Recall: Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
FDA Report: Jun 24, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-08.
Lots / Batch Codes & Expiration Dates
Lot #: AH001, expires: 8/31/2026
Distribution Scope
U.S.A. Nationwide

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