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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 541–560 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0172-2026

PeriGiene

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
Lots / Batch Codes & Expiration Dates
All lots on or before expiry date 08/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0165-2026

DermaSarra

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
Lots / Batch Codes & Expiration Dates
All lots on or before expiry date 08/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0162-2026

DermaFungal

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Lots / Batch Codes & Expiration Dates
All lots on or before expiry date 08/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0168-2026

KleenFoam Antimicrobial Foam Soap

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
Lots / Batch Codes & Expiration Dates
All lots on or before expiry date 08/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0170-2026

Lantiseptic

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Lots / Batch Codes & Expiration Dates
All lots on or before expiry date 08/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0154-2026

CLOMIPRAMINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
FDA Report: Nov 12, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.
Lots / Batch Codes & Expiration Dates
a) Lot # E403069, Exp Date: 04/2026; Lot # E406504, Exp Date: 07/2026; Lot # E309177, Exp Date: 11/2025; Lot # E400262, Exp Date: 12/2025; Lot # E404200, Exp Date: 05/2026 b) Lot # E403070, Exp Date: 04/2026; Lot # E406505, Exp Date: 07/2026; Lot # E407631, Exp Date: 08/2026; Lot # E400263, Exp Date: 12/2025; Lot # E404202, Exp Date: 05/2026 c) Lot...
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0153-2026

CLOMIPRAMINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
FDA Report: Nov 12, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
Lots / Batch Codes & Expiration Dates
a) Lot # E410157, Exp Date: 12/2026; Lot # E407176, Exp Date: 08/2026; Lot # E405845, Exp Date: 06/2026; Lot # E400943, Exp Date: 01/2026 b)Lot # E410156, Exp Date: 12/2026; Lot # E400942, Exp Date: 01/2026 c) Lot # E410158, Exp Date: 12/2026; Lot # E407128, Exp Date: 08/2026; Lot # E405846, Exp Date: 06/2026; Lot # E400944, Exp Date: 01/2026
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0152-2026

CLOMIPRAMINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
FDA Report: Nov 12, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India
Lots / Batch Codes & Expiration Dates
a) Lot # E408871, Exp Date: 10/2026; Lot # E405282, Exp Date: 06/2026; Lot # E400386, Exp Date: 12/2025 b) Lot # E408872, Exp Date: 10/2026; Lot # E405280, Exp Date: 06/2026 c) Lot # E408873, Exp Date: 10/2026; Lot # E405281, Exp Date: 06/2026; Lot # E400387, Exp Date: 12/2025
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0155-2026

AEROTAB PAIN RELIEVER

Manufacturer / Recalling Firm: Aero Healthcare
Reason for Recall: Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAI...
FDA Report: Nov 12, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01
Lots / Batch Codes & Expiration Dates
Lot # 9282, Exp Date: 2026-09-01; Lot # 9310, Exp Date: 2026-11-01
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0151-2026

Amoxicillin and Clavulanate Potassium for Oral Suspension USP

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Subpotent drug; Clavulanate Potassium component
FDA Report: Nov 12, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.
Lots / Batch Codes & Expiration Dates
Lot # 100062316, Exp Date: 01/2026
Distribution Scope
Distributed in three (3) States: MS, OH, CA.
Class II (Moderate Risk)
Drug recall Recall #: D-0110-2026

DESIPRAMINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Heritage Pharmaceuticals Inc
Reason for Recall: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Lots / Batch Codes & Expiration Dates
Lot#: 18036662, Exp. Date: 07/31/2026 Lot#: 18037649, Exp. Date: 03/31/2027
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0146-2026

LISDEXAMFETAMINE DIMESYLATE

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-048-88.
Lots / Batch Codes & Expiration Dates
Lot #: AD42470, Expiry: 2/28/2026; AD48708, Expiry:4/30/2026.
Distribution Scope
U.S Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0139-2026

EVEROLIMUS

Manufacturer / Recalling Firm: Endo USA, Inc.
Reason for Recall: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91
Lots / Batch Codes & Expiration Dates
Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0126-2026

Testosterone 87.5 MG

Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01
Lots / Batch Codes & Expiration Dates
Lot 3193, Exp 2/17/2026
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall Recall #: D-0147-2026

LISDEXAMFETAMINE DIMESYLATE

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-049-88.
Lots / Batch Codes & Expiration Dates
Lot #: AD48709, Expiry: 4/30/2026; AD50894, Expiry: 5/31/2026.
Distribution Scope
U.S Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0141-2026

EVEROLIMUS

Manufacturer / Recalling Firm: Endo USA, Inc.
Reason for Recall: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91
Lots / Batch Codes & Expiration Dates
Lot #: 550162801, Exp. Date NOV-25; 550169801, Exp. Date JAN-26
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0100-2026

DULOXETINE

Manufacturer / Recalling Firm: Breckenridge Pharmaceutical, Inc.
Reason for Recall: CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Lots / Batch Codes & Expiration Dates
90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0144-2026

LISDEXAMFETAMINE DIMESYLATE

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88.
Lots / Batch Codes & Expiration Dates
Lot #: AD42468, Expiry: 2/28/2026; AD48705, Expiry: 4/30/2026.
Distribution Scope
U.S Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0106-2026

PRAZOSIN HYDROCHLORIDE

Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05
Lots / Batch Codes & Expiration Dates
a) NDC 0093-4069-01: Lot # 3010403A, 3010385A, 3010404A, Exp Date: 02/2026; Lot # 3010405A, 3010510A, 3010528A, 3010354A, Exp Date: 03/2026; Lot # 3010592A, 3010605A, 3010611A, 3010612A, Exp Date: 08/2026; Lot # 3010655A, 3010703A, Exp Date: 02/2027 b) NDC 0093-4069-52: Lot # 3010430A, Exp Date: 11/2025, Lot # 3010613A, Exp Date: 08/2026 c) NDC 0...
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0129-2026

Testosterone Regular Release 200 MG

Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
FDA Report: Nov 05, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01
Lots / Batch Codes & Expiration Dates
Lot, expiry: 3201, Exp 2/7/2026; 3202, Exp 2/21/2026; 3280, Exp 4/8/2026; 3283, Exp /9/2026.
Distribution Scope
Nationwide in the USA and Antigua

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