FDA DrugsClass II

KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027, NDC 63981-171-80

Publicado: 10 de junio de 2026ID de Retiro: D-0557-2026Categoría: Medicamentos y FármacosPaís: Estados Unidos
US
PharmaceuticalFDA DrugsUSUS

KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027, NDC 63981-171-80

Recalling Firm: Guardian Drug Co. Inc.

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Traducir AvisoTranslate notice text, hazard warnings, and descriptions into any supported language.

Motivo del Retiro / Peligro

Presence of foreign substance: small metallic particles in chewable tablets.

Descripción del Producto e Identificación

KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027, NDC 63981-171-80

Additional Source Details

FieldValue
CityDayton
StateNJ
Openfda › UniiH0G9379FGK
Openfda › RouteORAL
Openfda › Rxcui308892
Openfda › Spl id4a1b0116-3aa0-4acc-a950-5a72158eaf33
Openfda › Brand nameKIRKLAND ULTRA STREGTH ANTACID 171AB
Openfda › Spl set id1bea92e8-1b94-77b0-e063-6394a90a8212
Openfda › Package ndc63981-171-80
Openfda › Product ndc63981-171
Openfda › Generic nameCALCIUM CARBONATE
Openfda › Product typeHUMAN OTC DRUG
Openfda › Substance nameCALCIUM CARBONATE
Openfda › Manufacturer nameCOSTCO WHOLESALE COMPANY
Openfda › Application numberM001
Openfda › Is original packagertrue
Event id99098
Address 12 Charles Ct
Code infoLot#: 1716059, 1716060, 1716061, 1716062, 1716063, 1716218, 1716219, 1716228, 1716229, 1716238, Exp 2/28/2029; 1716258, Exp 3/31/2029.
Postal code08810-1508
Report date20260610
Product typeDrugs
Reason for recallPresence of foreign substance: small metallic particles in chewable tablets.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260528
Initial firm notificationLetter
Center classification date20260603

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN D...?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Resumen

  • Empresa ResponsableGuardian Drug Co. Inc.
  • StatusOngoing
  • Nivel de RiesgoClass II
  • DistributionU.S.A. Nationwide
Recall Hazard Severity
High Alert (Class I)
Alerta Oficial de la Agencia

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🚨 SAFETY ALERT: Guardian Drug Co. Inc. - KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027, NDC 63981-171-80

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