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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 121–140 of 999 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0569-2026

FAMILY WELLNESS

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
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., UP: 0 32251-92282-4.
Lots / Batch Codes & Expiration Dates
Lot #: 1716259, expires: MAR 2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0584-2026

NIACIN

Manufacturer / Recalling Firm: Lannett Company Inc.
Reason for Recall: Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
FDA Report: Jun 10, 2026 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46.
Lots / Batch Codes & Expiration Dates
Lot #: 25282724A, Exp. Date 2027/01
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0560-2026

GOOD NEIGHBOR PHARMACY 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
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable, 96-count bottle, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-106-80.
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-0599-2026

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), 3mg, 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 72245-058-10
Lots / Batch Codes & Expiration Dates
Lot #: AE11393, Exp Date: 10/2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall Recall #: D-0570-2026

Harris Teeter

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
Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1.
Lots / Batch Codes & Expiration Dates
Lot #: 1716089, expires: JAN 2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0573-2026

HEB EXTRA STREGTH 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
H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC 37808-136-22.
Lots / Batch Codes & Expiration Dates
Lot #: 1276118, expires: JAN 2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0563-2026

24/7 life BY 7-ELEVEN

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
24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-ELEVEN, IRVING, TX 75063, UPC 0 5254863573 2.
Lots / Batch Codes & Expiration Dates
Lot #: 1276119, Exp 1/31/2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0564-2026

MARKET BASKET ANTACID Calcium Carbonate 1000 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
MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc.,Tewksbury, Mass 01875, UPC 0 49705 83149 6.
Lots / Batch Codes & Expiration Dates
Lot #: 1716089, expires: JAN 2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0568-2026

FAMILY WELLNESS ULTRA STRENGTH ASSORTED FRUIT 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
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., NDC 55319-171-68.
Lots / Batch Codes & Expiration Dates
Lot #: 1716089, expires: JAN 2029.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-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

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