Home/Recalls/FDA-D-0557-2026
FDA DrugsClass II

KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-coun...

Published: June 10, 2026Recall ID: D-0557-2026Category: drugsCountry: US

Reason for Recall / Hazard

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

Product Description & Identification

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

Overview

  • Recalling FirmGuardian Drug Co. Inc.
  • StatusOngoing
  • Risk LevelClass II
  • DistributionU.S.A. Nationwide
Official Agency Alert