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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 301–320 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0578-2026

TOPCARE 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
TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-22.
Lots / Batch Codes & Expiration Dates
Lot #: 1276119, expires: JAN- 2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0555-2026

DULOXETINE

Manufacturer / Recalling Firm: Asclemed USA Inc.
Reason for Recall: CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
FDA Report: Jun 10, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
Lots / Batch Codes & Expiration Dates
Lot # 050725G-30 & 050725F-30, Exp Date: 06/30/2026
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall Recall #: D-0556-2026

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
FDA Report: Jun 10, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.
Lots / Batch Codes & Expiration Dates
Lot: 24123460, Expires: October 31, 2027.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0562-2026

Extra strength Antacid Calcium Carbonate 750 mg

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
Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COMPANY, ANKENY, IA 50521, UPC: 0 98437 24361 9.
Lots / Batch Codes & Expiration Dates
Lot #: 1276118, Exp 1/31/2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0598-2026

Xyvona

Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
FDA Report: Jun 10, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-762-10
Lots / Batch Codes & Expiration Dates
Lot #: AD93852, Exp Date: 06/2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0561-2026

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
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-595-23.
Lots / Batch Codes & Expiration Dates
Lot #: 1716089, Exp 1/31/2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0576-2026

EQUALINE EXTRA STRENGTH ASSORTED BERRY 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
EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22.
Lots / Batch Codes & Expiration Dates
Lot #: 1276118, expires: JAN- 2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0574-2026

GOODSENSE 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
GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22.
Lots / Batch Codes & Expiration Dates
Lot #: 1276118, expires: JAN- 2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0577-2026

EQU ULTRA STRENGTH ANTACID ASSORTED FRUIT 171AF

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
EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68.
Lots / Batch Codes & Expiration Dates
Lot #: 1716089, expires: JAN- 2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0566-2026

ULTRA STRENGTH ANTACID ASSORTED BERRIES

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, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23.
Lots / Batch Codes & Expiration Dates
Lot #: 1716259, Exp 3/31/2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0567-2026

DISCOUNT drug mart

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
DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8.
Lots / Batch Codes & Expiration Dates
Lot #: 1276118, Exp 1/31/2029.
Distribution Scope
U.S.A. Nationwide
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

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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