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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
11 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 921–940 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0632-2025

CHLORPROMAZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
FDA Report: Sep 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1130-1
Lots / Batch Codes & Expiration Dates
Lot #: Z305060, Z305061, Exp Date 31-08-25; Z306323, Exp Date 30-11-25; Z401153, Exp Date 28-02-26; Z403015, Z403016, Exp Date 30-04-26; Z405591, Exp Date 30-09-26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0633-2025

CHLORPROMAZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
FDA Report: Sep 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01
Lots / Batch Codes & Expiration Dates
Lot #: Z305062, exp 31-08-25; Z306324, Exp Date 30-11-25; Z401151, Z401152, Exp Date 28-02-26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0626-2025

CIPROFLOXACIN AND DEXAMETHASONE

Manufacturer / Recalling Firm: Sandoz Inc
Reason for Recall: Temperature Abuse
FDA Report: Sep 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ, NDC# 0781-6186-67, Carton NDC# 0781-6186-67
Lots / Batch Codes & Expiration Dates
Lot # VNF35A, Exp.08/31/2026
Distribution Scope
Product was distributed to one consignee in CA.
Class II (Moderate Risk)
Drug recall Recall #: D-0622-2025

Iodo Blanco Iodides

Manufacturer / Recalling Firm: World Perfumes Inc.
Reason for Recall: Defective Container: broken or leaking bottles.
FDA Report: Sep 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle, Distributed by: Essential Products, www.essentialproductsusa.com, NDC: 70242-109-01
Lots / Batch Codes & Expiration Dates
Lot 230619, Exp 06/30/2026
Distribution Scope
FL
Class II (Moderate Risk)
Drug recall Recall #: D-0637-2025

CHLORPROMAZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
FDA Report: Sep 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-050-01
Lots / Batch Codes & Expiration Dates
Lot #: Z305456, Exp Date 31-10-25; Z401156, Exp Date 28-02-26; Z407306, Exp Date 30-11-26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0630-2025

CHLORPROMAZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
FDA Report: Sep 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1
Lots / Batch Codes & Expiration Dates
Lot #: Z403012, Exp Date 30-04-26; Z406657, Exp Date 30-11-26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0634-2025

CHLORPROMAZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
FDA Report: Sep 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1131-1
Lots / Batch Codes & Expiration Dates
Lot #: Z306327, Exp Date 30-11-25; Z306748, Exp Date 30-11-25; Z401154, Exp Date 28-02-26; Z403738, Exp Date 31-05-26; Z405645, Exp Date 30-09-26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0609-2025

Semaglutide

Manufacturer / Recalling Firm: Boothwyn Pharmacy LLC
Reason for Recall: Subpotent Drug
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Lots / Batch Codes & Expiration Dates
03202025@2, 03202025@3 and 03202025@4 BUD 07/18/2025
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0614-2025

KIMMTRAK

Manufacturer / Recalling Firm: IMMUNOCORE, LLC
Reason for Recall: Subpotent Drug
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026
Lots / Batch Codes & Expiration Dates
NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026
Distribution Scope
US Nationwide
Class I (High Risk)
Drug recall Recall #: D-0627-2025

LACTATED RINGERS

Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Presence of Particulate Matter
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
Lots / Batch Codes & Expiration Dates
Lot #: J4S807, Exp 5/31/2027
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0606-2025

Semaglutide

Manufacturer / Recalling Firm: Boothwyn Pharmacy LLC
Reason for Recall: Subpotent Drug
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Lots / Batch Codes & Expiration Dates
03202025@5, 03202025@6, 03202025@7, 03202025@8 BUD 07/18/2025
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0617-2025

CHLORPROMAZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Amneal Pharmaceuticals, LLC
Reason for Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.
Lots / Batch Codes & Expiration Dates
Lot: AM240147, AM240148, Exp Date 01/31/2027; Lot AM240664, AM240665, Exp Date 04/30/2027.
Distribution Scope
Distributed Nationwide in the USA
Class I (High Risk)
Drug recall Recall #: D-0612-2025

KleenFoam

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (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
Lot #: 30705A, Exp. Date 8/2025; 30771A, Exp. Date 9/2025; 30920A, Exp. Date 10/2025; 40016A, Exp. Date 1/2026; 40303A, Exp. Date 4/2026; 40428A, Exp. Date 5/2026; 40505A, Exp. Date 6/2026; 41053C, 41053A, 41053B, Exp. Date 12/2026, 50017A, Exp. Date 1/2027.
Distribution Scope
Nationwide within the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0615-2025

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Manufacturer / Recalling Firm: Amneal Pharmaceuticals, LLC
Reason for Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
Lots / Batch Codes & Expiration Dates
Lot a) AM240173, Exp Date 01/31/2027, AM240680, Exp Date 05/31/2027, AM 240921, Exp Date 06/30/2027, AM241191, Exp Date 08/31/2027. Lot b) AM240176, AM240177, Exp Date 01/31/2027, AM240301, AM240300, Exp Date 02/28/2027, AM240676, AM240677, Exp Date 04/30/2027, AM240678, AM240679, Exp Date 05/30/2027. AM240922, AM240923, AM240924, AM240925, Exp Da...
Distribution Scope
Distributed Nationwide in the USA
Class I (High Risk)
Drug recall Recall #: D-0610-2025

DermaKleen

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. oz.) bag-n-box (NDC 61924-092-34) , DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Lots / Batch Codes & Expiration Dates
Lot # and Expiration Date: a) 30550A, Exp. Date 7/2025; 30670A, 30682A, Exp. Date 8/2025; 40025A, Exp. Date 1/2026; 40375A, Exp. Date 4/2026; 40427A, 40436A, Exp. Date 5/2026; 50068A, Exp. Date 1/2027. b)30586A, 30586B, 30626A, Exp. Date 7/2025; 30628A, 30657A, Exp. Date 8/2025; 30741A, Exp. Date 7/2025; 30871A, Exp. Date 10/2025; 40002A, Exp. D...
Distribution Scope
Nationwide within the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0616-2025

CHLORPROMAZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Amneal Pharmaceuticals, LLC
Reason for Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1.
Lots / Batch Codes & Expiration Dates
Lot AM240617, AM240618, Exp Date 04/30/2027
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0618-2025

CHLORPROMAZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Amneal Pharmaceuticals, LLC
Reason for Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.
Lots / Batch Codes & Expiration Dates
Lot: AM240334, AM240335, Exp Date 02/28/2027, AM241031, Exp Date 06/30/2027.
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0619-2025

CHLORPROMAZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Amneal Pharmaceuticals, LLC
Reason for Recall: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.
Lots / Batch Codes & Expiration Dates
Lot: AM240336, AM240337, Exp Date 02/28/2027.
Distribution Scope
Distributed Nationwide in the USA
Class III (Low Risk)
Drug recall Recall #: D-0607-2025

Fluorescein 2% Ophth

Manufacturer / Recalling Firm: Boothwyn Pharmacy LLC
Reason for Recall: Subpotent Drug
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
Lots / Batch Codes & Expiration Dates
06092025@23 BUD 09/09/2025
Distribution Scope
U.S. Nationwide
Class I (High Risk)
Drug recall Recall #: D-0611-2025

DermaSarra

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
FDA Report: Sep 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
DermaSarra, External Analgesic, (Camphor 0.5%) 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
Lot #: 40187.2, Exp. Date 2/2026
Distribution Scope
Nationwide within the USA

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