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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 141–160 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0559-2026

HALEON CALCIUM CARBONATE TUMS ANTACID

Manufacturer / Recalling Firm: Guardian Drug Co. Inc.
Reason for Recall: Presence of foreign substance: small metallic particles in chewable tablets.
FDA Report: Jun 10, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9.
Lots / Batch Codes & Expiration Dates
Lot #: 1076169, Exp 2/28/2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0575-2026

GOODSENSE ULTRA STRENGTH ANTACID ASSORTED FRUIT

Manufacturer / Recalling Firm: Guardian Drug Co. Inc.
Reason for Recall: Presence of foreign substance: small metallic particles in chewable tablets.
FDA Report: Jun 10, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68.
Lots / Batch Codes & Expiration Dates
Lot #: 1716089, expires: JAN- 2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0579-2026

TOPCARE ULTRA STRENGTH ANTACID ASSORTED FRUIT

Manufacturer / Recalling Firm: Guardian Drug Co. Inc.
Reason for Recall: Presence of foreign substance: small metallic particles in chewable tablets.
FDA Report: Jun 10, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129-68.
Lots / Batch Codes & Expiration Dates
Lot #: 1716089, expires: JAN- 2029.
Distribution Scope
U.S.A. Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0552-2026

LIDOLOG KIT

Manufacturer / Recalling Firm: Eugia US LLC
Reason for Recall: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
FDA Report: Jun 10, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 3LC26029A, exp Feb-2029; Lot 3LC26031A, exp Mar-2029
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0571-2026

HyVee

Manufacturer / Recalling Firm: Guardian Drug Co. Inc.
Reason for Recall: Presence of foreign substance: small metallic particles in chewable tablets.
FDA Report: Jun 10, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1.
Lots / Batch Codes & Expiration Dates
Lot #: 1276119, expires: Jan 2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0565-2026

EXTRA STRENGTH ANTACID

Manufacturer / Recalling Firm: Guardian Drug Co. Inc.
Reason for Recall: Presence of foreign substance: small metallic particles in chewable tablets.
FDA Report: Jun 10, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80.
Lots / Batch Codes & Expiration Dates
Lot #: 1276118, 1276119, expires: JAN 2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0572-2026

HyVee

Manufacturer / Recalling Firm: Guardian Drug Co. Inc.
Reason for Recall: Presence of foreign substance: small metallic particles in chewable tablets.
FDA Report: Jun 10, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5.
Lots / Batch Codes & Expiration Dates
Lot #: 1716089, expires: JAN 2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0554-2026

LIDOCAINE HYDROCHLORIDE

Manufacturer / Recalling Firm: Spectra Medical Devices, Llc
Reason for Recall: Lack of Assurance of Sterility
FDA Report: Jun 10, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1.
Lots / Batch Codes & Expiration Dates
Lot#: AE4013, Exp 1/31/2027; AE5032 & AE5039, Exp 3/31/2028; AE5104, Exp 8/31/2028.
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0558-2026

HALEON CALCIUM CARBONATE TUMS ANTACID

Manufacturer / Recalling Firm: Guardian Drug Co. Inc.
Reason for Recall: Presence of foreign substance: small metallic particles in chewable tablets.
FDA Report: Jun 10, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.
Lots / Batch Codes & Expiration Dates
Lot #: 1096075, 1096076, 1096077, 1096078, Exp 1/31/2029.
Distribution Scope
U.S.A. Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0551-2026

PRED MILD

Manufacturer / Recalling Firm: AbbVie Inc.
Reason for Recall: Failed Stability Specifications
FDA Report: Jun 03, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.
Lots / Batch Codes & Expiration Dates
Lot # 402805, 407596, Exp Date: 08/2026.
Distribution Scope
US Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0550-2026

NICOTINE

Manufacturer / Recalling Firm: AVEVA Drug Delivery Systems, Inc.
Reason for Recall: Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
FDA Report: Jun 03, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
Lots / Batch Codes & Expiration Dates
Lot #: 56841, Expires: 03/2028
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall Recall #: D-0549-2026

Vitamin B-Complex

Manufacturer / Recalling Firm: Safecor Health, LLC
Reason for Recall: Presence of a Foreign Substance; black particles observed in liquid
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lots 26110722, 26110743, exp 9/8/2026; Lot 26111218, exp 9/9/2026
Distribution Scope
OH
Class II (Moderate Risk)
Drug recall Recall #: D-0542-2026

Gas-X

Manufacturer / Recalling Firm: Haleon US Holdings LLC
Reason for Recall: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Lots / Batch Codes & Expiration Dates
Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
Distribution Scope
U.S. Nationwide.
Class III (Low Risk)
Drug recall Recall #: D-0533-2026

PRIMIDONE

Manufacturer / Recalling Firm: Lannett Company Inc.
Reason for Recall: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Lots / Batch Codes & Expiration Dates
Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.
Distribution Scope
USA Nationwide
Class III (Low Risk)
Drug recall Recall #: D-0539-2026

BUSULFAN

Manufacturer / Recalling Firm: Sagent Pharmaceuticals
Reason for Recall: Failed Impurities/Degradation Specifications
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.
Lots / Batch Codes & Expiration Dates
Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0543-2026

ESTRADIOL

Manufacturer / Recalling Firm: ANI Pharmaceuticals, Inc.
Reason for Recall: Defective Container; packets were found to be either empty or partially full.
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
Lots / Batch Codes & Expiration Dates
Lot M251109, exp Nov 2027
Distribution Scope
Nationwide in the USA
Class III (Low Risk)
Drug recall Recall #: D-0536-2026

PRIMIDONE

Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Lots / Batch Codes & Expiration Dates
Lot#: 1027583, Exp 09/30/2027
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0546-2026

CIMZIA

Manufacturer / Recalling Firm: UCB Biosciences Inc.
Reason for Recall: Lack of Assurance of Sterility
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, NDC 50474-710-81.
Lots / Batch Codes & Expiration Dates
Lot: CVZFW, Exp.:2026-JUL-04; CVZYG, Exp.: 2026-AUG-19; CWSYT, Exp.: 2026-OCT-22; CWDZY, Exp.:2026-NOV-20; CWTSD, Exp.:2026-DEC-11; CVTFK, Exp.:2026-JUL-04; CVTSN, Exp.: 2026-AUG-19; CWVGP. Exp.:2026-DEC-11; CVWXT, CVWXV, CVWXW, Exp.:2026-JUL-04; CWHFF, Exp.: 2026-OCT-...
Distribution Scope
US Nationwide.
Class I (High Risk)
Drug recall Recall #: D-0553-2026

MG217 Multi-Symptom Treatment Cream & Skin Protectant

Manufacturer / Recalling Firm: Wisconsin Pharmacal Company
Reason for Recall: Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.
Lots / Batch Codes & Expiration Dates
Lot #: 1024088, Exp 11/30/2026
Distribution Scope
USA Nationwide and Bahamas
Class III (Low Risk)
Drug recall Recall #: D-0535-2026

PRIMIDONE

Manufacturer / Recalling Firm: Golden State Medical Supply Inc.
Reason for Recall: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA Report: May 27, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
Lots / Batch Codes & Expiration Dates
Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
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

Confirm Action