Home/Recalls/FDA-D-0579-2026
FDA DrugsClass II

TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CH...

Published: June 10, 2026Recall ID: D-0579-2026Category: drugsCountry: US

Reason for Recall / Hazard

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

Product Description & Identification

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.

Additional Source Details

FieldValue
CityDayton
StateNJ
Openfda › Upc0036800498372
Openfda › UniiH0G9379FGK
Openfda › RouteORAL
Openfda › Rxcui308892
Openfda › Spl id4a9ae0bb-b3f7-4a69-84f5-d2ea3a6c7be7
Openfda › Brand nameTOPCARE ULTRA STRENGTH ANTACID ASSORTED FRUIT
Openfda › Spl set iddd038b15-2ecb-4ee2-b356-db6d87c2f01b
Openfda › Package ndc76162-129-68
Openfda › Product ndc76162-129
Openfda › Generic nameCALCIUM CARBONATE
Openfda › Product typeHUMAN OTC DRUG
Openfda › Substance nameCALCIUM CARBONATE
Openfda › Manufacturer nameTopco Associates, LLC
Openfda › Application numberM001
Openfda › Is original packagertrue
Event id99098
Address 12 Charles Ct
Code infoLot #: 1716089, expires: JAN- 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