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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 741–760 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0640-2025

Ultra Violette

Manufacturer / Recalling Firm: GRACE & FIRE PTY LTD
Reason for Recall: Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
FDA Report: Sep 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl. oz. per tube, NDC 84803-106-01, UPC 9355909006068, b) 50 mL, 1.7 fl. oz. per tube, NDC 84803-106-02, UPC 9355909005924, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808.
Lots / Batch Codes & Expiration Dates
Lot #s: a) 15 mL tubes: A2455, exp 12/31/2026; b) 50 mL tubes: A2453A, A2453B, exp 11/30/2026; A2454A, exp 12/31/2026; A2550, exp 02/28/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0636-2025

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; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1132-1
Lots / Batch Codes & Expiration Dates
Lot #: Z305079, Z305080, Exp Date 30-09-25; Z305454, Z305455, Z305457, Z400492, Z400493, Z400494, Exp Date 31-12-25; Z401158, Z401725, Z401726, Exp. Date 28-02-26; Z404118, Z404119, Z404120, Exp Date 30-06-26; Z405648, Exp Date 30-09-26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0623-2025

SUCCINYLCHOLINE CHLORIDE

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
FDA Report: Sep 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesciences Ltd, Vadodara, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1377-1 (vial), NDC 70710-1377-2 (carton).
Lots / Batch Codes & Expiration Dates
Lot #s: L400077, exp: 8/31/2025; L400113, exp.: 9/30/2025; L400372, L400373, exp.: 3/31/2026; L400374, exp.: 4/30/2026.
Distribution Scope
MS, OH, LA, and Puerto Rico
Class II (Moderate Risk)
Drug recall Recall #: D-0641-2025

Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen

Manufacturer / Recalling Firm: GRACE & FIRE PTY LTD
Reason for Recall: Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen revealed inconsistency in SPF results ranging from SPF 4, 10, 21, 26, 33, 60, 61, and 64.
FDA Report: Sep 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ultra Violette Mini SPF Mates kit includes: Velvet Screen SPF 50 Blurring Mineral SkinScreen, Zinc Oxide 22.75%, 15 mL, 0.5 fl. oz. per tube, Supreme Sunscreen SPF 50, 15 mL 0.5 fl. oz. per tube, Distributed by: Grace & Fire USA Inc., 251 Little Falls Drive, New Castle Wilmington, Delaware 19808, NDC 84803-110-01 (15 mL Velvet Screen), UPC 9355909005757.
Lots / Batch Codes & Expiration Dates
Lot #s: A2453, exp 11/30/2026; A2454, exp 12/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0629-2025

Neuroquell & Neuroquell Plus

Manufacturer / Recalling Firm: Atlantic Management Resources Ltd.
Reason for Recall: cGMP violations
FDA Report: Sep 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-01
Lots / Batch Codes & Expiration Dates
Lot # B-02 Batch #: 1087920520 Product # R937 BBE#31-05-21( May 31, 2021) Batch # 1087920920 Product # R937 BBE# 31-05-21 (May 31, 2021)
Distribution Scope
Product was distributed via the internet.
Class II (Moderate Risk)
Drug recall Recall #: D-0644-2025

CHLORPROMAZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Presence of a foreign substance.
FDA Report: Sep 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15
Lots / Batch Codes & Expiration Dates
Lot # 47089, Exp 12/31/25; 47604, Exp 03/31/26
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0635-2025

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; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-049-01
Lots / Batch Codes & Expiration Dates
Lot #: Z306326, Exp Date 30-11-25; Z401155, Exp Date 28-02-26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0639-2025

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, 200 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-051-01
Lots / Batch Codes & Expiration Dates
Lot #: Z305085, Exp Date 30-09-25; Z401166, Z401167, Exp Date 28-02-26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0643-2025

CHLORPROMAZINE HYDROCHLORIDE

Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Presence of a foreign substance.
FDA Report: Sep 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15
Lots / Batch Codes & Expiration Dates
Lot # 46824, Exp 9/30/25; 47171, Exp 12/31/25
Distribution Scope
USA Nationwide
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

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