Home/Recalls/FDA-D-0565-2026
FDA DrugsClass II

CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable T...

Published: June 10, 2026Recall ID: D-0565-2026Category: drugsCountry: US

Reason for Recall / Hazard

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

Product Description & Identification

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.

Additional Source Details

FieldValue
CityDayton
StateNJ
Openfda › Upc › 10341520317309
Openfda › Upc › 20341520312120
Openfda › UniiH0G9379FGK
Openfda › RouteORAL
Openfda › Rxcui308915
Openfda › Spl id057e20c1-e214-4696-ba68-a3c160dd91f5
Openfda › Brand nameEXTRA STRENGTH ANTACID
Openfda › Spl set id1e97c054-d6b3-425a-e063-6394a90af836
Openfda › Package ndc › 172476-127-80
Openfda › Package ndc › 272476-127-82
Openfda › Product ndc72476-127
Openfda › Generic nameCALCIUM CARBONATE
Openfda › Product typeHUMAN OTC DRUG
Openfda › Substance nameCALCIUM CARBONATE
Openfda › Manufacturer nameRetail Business Services, LLC.
Openfda › Application numberM001
Openfda › Is original packagertrue
Event id99098
Address 12 Charles Ct
Code infoLot #: 1276118, 1276119, 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