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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 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 641–660 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0232-2026

MEPIVACAINE

Manufacturer / Recalling Firm: Novocol Pharmaceutical of Canada, Inc.
Reason for Recall: Defective container: cracked/broken cartridges
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.
Lots / Batch Codes & Expiration Dates
Lot: D05159H, expires: 07-31-2027
Distribution Scope
U.S.A. Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0238-2026

CISATRACURIUM BESYLATE

Manufacturer / Recalling Firm: SOMERSET THERAPEUTICS LLC
Reason for Recall: Subpotent product:out of specification assay results observed during long term stability testing.
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, NDC 70069-161-01; 10x10mL Multiple-dose vials per Carton, NDC 70069-161-01.
Lots / Batch Codes & Expiration Dates
Lot#: A250043, EXP Date 06/30/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0240-2026

Ciclopirox Shampoo

Manufacturer / Recalling Firm: SUN PHARMA /TARO
Reason for Recall: Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
Lots / Batch Codes & Expiration Dates
Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0235-2026

BACLOFEN

Manufacturer / Recalling Firm: Golden State Medical Supply Inc.
Reason for Recall: Presence of Foreign Tablets/Capsules
FDA Report: Dec 24, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10
Lots / Batch Codes & Expiration Dates
Lot GS065762
Distribution Scope
Nationwide within the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0221-2026

Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution

Manufacturer / Recalling Firm: Fagron Compounding Services
Reason for Recall: Incorrect Product Formulation
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical Ophthalmic Use Only. Not for IV Use. Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67226. NDC: 71266-8240-01
Lots / Batch Codes & Expiration Dates
Lot#: C274-000047958; Exp. December 19, 2025
Distribution Scope
U.S. Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0222-2026

NEBIVOLOL

Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: Cross Contamination with Other Products
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy, NDC 42291-874-90.
Lots / Batch Codes & Expiration Dates
Lot# 17240988; Exp. 05/31/2026
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0225-2026

CINACALCET

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
Lots / Batch Codes & Expiration Dates
Lot 5PB0164, exp 1/31/2027
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0218-2026

LANTHANUM CARBONATE

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Failed stability specifications: Out of specification for hardness test
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.
Lots / Batch Codes & Expiration Dates
Lot# NB240314, exp 12/31/2025
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0224-2026

CINACALCET

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 4PB0109, exp 1/31/2026; Lot 5PB0172, exp 1/31/2027
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0226-2026

CINACALCET

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02
Lots / Batch Codes & Expiration Dates
Lot 5PB0183, exp 1/31/2027
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall Recall #: D-0227-2026

SERTRALINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Lupin Pharmaceuticals Inc.
Reason for Recall: Defective container - seal not adhering to bottles
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Lots / Batch Codes & Expiration Dates
Lot # QB00865, exp. date Feb 2028
Distribution Scope
Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0220-2026

GANIRELIX ACETATE

Manufacturer / Recalling Firm: Lupin Pharmaceuticals Inc.
Reason for Recall: Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01
Lots / Batch Codes & Expiration Dates
Lot #: WB00006, Exp 12/31/2026
Distribution Scope
FL, MA, MI & OH
Class III (Low Risk)
Drug recall Recall #: D-0223-2026

MORPHINE SULFATE

Manufacturer / Recalling Firm: Winder Laboratories, LLC
Reason for Recall: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01
Lots / Batch Codes & Expiration Dates
Lot 1312405; Exp 09/28/2027
Distribution Scope
U.S. Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0219-2026

VARENICLINE TARTRATE

Manufacturer / Recalling Firm: Dr. Reddy's Laboratories, Inc.
Reason for Recall: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56
Lots / Batch Codes & Expiration Dates
Lot # F2400244, Exp Date: 10/31/2026
Distribution Scope
Distributed Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0217-2026

LANTHANUM CARBONATE

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Failed stability specifications: Out of specification for hardness test
FDA Report: Dec 17, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.
Lots / Batch Codes & Expiration Dates
lot# NB240315, exp 12/31/2025
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0205-2026

ZINC OXIDE

Manufacturer / Recalling Firm: Blossom Pharmaceuticals
Reason for Recall: cGMP deviations
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.
Lots / Batch Codes & Expiration Dates
Lot #: A062434, Exp. Date 6/27 & A062449, Exp. Date 7/27
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0204-2026

Dynagel

Manufacturer / Recalling Firm: Blossom Pharmaceuticals
Reason for Recall: cGMP deviations
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.
Lots / Batch Codes & Expiration Dates
Lot #: A322301, Exp. Date 7/26 & A322302, Exp. Date 8/26
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0211-2026

CLOTRIMAZOLE

Manufacturer / Recalling Firm: Blossom Pharmaceuticals
Reason for Recall: cGMP deviations
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.
Lots / Batch Codes & Expiration Dates
Lot #: A472418
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0208-2026

NIVAGEN ZINC OXIDE

Manufacturer / Recalling Firm: Blossom Pharmaceuticals
Reason for Recall: cGMP deviations
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.
Lots / Batch Codes & Expiration Dates
Lot #: A352405
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0201-2026

Lanashield Skin Barrier

Manufacturer / Recalling Firm: Blossom Pharmaceuticals
Reason for Recall: cGMP deviations
FDA Report: Dec 10, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.
Lots / Batch Codes & Expiration Dates
Lot #: A162301, Exp. Date 9/26; A162401, Exp. Date 4/27 & A162202, Exp. Date 11/25.
Distribution Scope
USA 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

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