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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 401–420 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0298-2026

INON ACE

Manufacturer / Recalling Firm: Sato Pharmaceutical Co., Ltd
Reason for Recall: Failed Disintegration Specifications: above the time expected.
FDA Report: Feb 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Lots / Batch Codes & Expiration Dates
Lot#: PWXT, Exp 1/31/2027
Distribution Scope
CA and HI
Class II (Moderate Risk)
Drug recall Recall #: D-0299-2026

METHYLPREDNISOLONE

Manufacturer / Recalling Firm: Greenstone Llc
Reason for Recall: Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
FDA Report: Feb 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2
Lots / Batch Codes & Expiration Dates
Lot # LG7675, Exp. Date Nov 2026
Distribution Scope
Nationwide within the United States
Class III (Low Risk)
Drug recall Recall #: D-0300-2026

GLYCOPYRROLATE

Manufacturer / Recalling Firm: NOVADOZ PHARMACEUTICALS LLC
Reason for Recall: Failed Impurities/Degradation Specifications
FDA Report: Feb 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72
Lots / Batch Codes & Expiration Dates
Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0296-2026

STERILE WATER

Manufacturer / Recalling Firm: Baxter Healthcare Corporation
Reason for Recall: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
FDA Report: Feb 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Lots / Batch Codes & Expiration Dates
Lot #: G171359, expiry: 05/31/2027
Distribution Scope
Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0297-2026

PARODONTAX

Manufacturer / Recalling Firm: Haleon US Holdings LLC
Reason for Recall: Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
FDA Report: Feb 04, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02
Lots / Batch Codes & Expiration Dates
Lot #: 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0294-2026

Thyroid

Manufacturer / Recalling Firm: Specialty Process Labs LLC
Reason for Recall: Subpotent Drug
FDA Report: Jan 28, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02
Lots / Batch Codes & Expiration Dates
Lot #H22254-1XV; Exp. 01/31/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0293-2026

FUROSEMIDE

Manufacturer / Recalling Firm: Graviti Pharmaceuticals Private Limited
Reason for Recall: Presence of Foreign Substance
FDA Report: Jan 28, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, India, NDC 64980-563-10.
Lots / Batch Codes & Expiration Dates
Lot# FUB125042G; Exp. 05/13/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0295-2026

Icosapent Ethyl capsules

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
FDA Report: Jan 28, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
Lots / Batch Codes & Expiration Dates
Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
Distribution Scope
US Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0291-2026

DICLOFENAC SODIUM

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Failed PH Specifications
FDA Report: Jan 28, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
Lots / Batch Codes & Expiration Dates
Batch XHBG; Exp. 08/31/2027
Distribution Scope
Nationwide in the USA
Class III (Low Risk)
Drug recall Recall #: D-0257-2026

CLINDAMYCIN PHOSPHATE

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
Lots / Batch Codes & Expiration Dates
Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0264-2026

Benadryl

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Benadryl, 25'S 2PK Box, UPC 815556020316
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0263-2026

Alka Seltzer

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0267-2026

DAYQUIL COLD & FLU

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
DAYQUIL COLD & FLU, 32CT/2PK
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0276-2026

PEPCID COMPLETE - 25CT

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
PEPCID COMPLETE - 25CT
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0265-2026

Bayer 2Pk- 25 CT

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Bayer 2Pk- 25 CT
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0259-2026

LEVOTHYROXINE SODIUM

Manufacturer / Recalling Firm: Alvogen, Inc
Reason for Recall: Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Levothyroxine Sodium Tablets, USP, Thyro-Tabs, 150mcg, 1000 Tablets, Rx only, Manufactured by: LLOYD, Inc., Shenandoah, IA, 51601 USA, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058 USA, NDC: 47781-662-10.
Lots / Batch Codes & Expiration Dates
Lot # MHA21825, Exp Date: December 31, 2027
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0258-2026

TESTO-100 CIII

Manufacturer / Recalling Firm: Advanced Pharmaceutical Technology, Inc.
Reason for Recall: Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
Lots / Batch Codes & Expiration Dates
Lot #: P-22-3, Exp 06-2027
Distribution Scope
GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece
Class II (Moderate Risk)
Drug recall Recall #: D-0266-2026

Claritin

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Claritin, 20 Count, UPC: 655708016305
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0273-2026

NYQUIL COLD & FLU -32CT/2PK

Manufacturer / Recalling Firm: GOLD STAR DISTRIBUTION INC
Reason for Recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
NYQUIL COLD & FLU -32CT/2PK
Lots / Batch Codes & Expiration Dates
All lots within expiry distributed by Gold Star Distribution.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0290-2026

LANREOTIDE ACETATE

Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Presence of Particulate Matter.
FDA Report: Jan 21, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Lots / Batch Codes & Expiration Dates
Lot, expiry: 4301954IR1 , exp 31/10/2026 ; 4301994IR1 , exp 31/10/2026 ; 4301995IR1 , exp 31/10/2026 ; 4301996IR1 , exp 31/10/2026 ; 4400005IR1 , exp 30/11/2026 ; 4400006IR1 , exp 30/11/2026 ; 4400007IR1 , exp 30/11/2026 ; 4400124IR1 , exp 30/11/2026 ; 4400154IR1 , exp 30/11/2026 ; 4400155IR1 , exp 30/11/2026 ; 4400156IR1 , ex...
Distribution Scope
Nationwide in 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