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Recall Observatory FDA recall evidence

Drug product

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

D-0557-2026

May 28, 2026

Class II

Product summary

Firm
Guardian Drug Co. Inc.
Event
Event 99098
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0557-2026

Official wording

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

Code information: Lot#: 1716059, 1716060, 1716061, 1716062, 1716063, 1716218, 1716219, 1716228, 1716229, 1716238, Exp 2/28/2029; 1716258, Exp 3/31/2029.

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign substance