Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated May 28, 2026 (5 months ago)

KIRKLAND Signature (Calcium Carbonate)

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

Cause type: Particulate / foreign matter

Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.

What was recalled

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

Affected NDC 63981-0171-80

Compare with the code on your package — it is the most precise check available.

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Kirkland Ultra Stregth Antacid 171AB
Calcium carbonate
NDC 63981-0171
1000 mg/1 Tablet
Oral
Costco Wholesale Company OTC
Recalling firm
Guardian Drug Co. Inc.
NDC code
63981-171-80
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0557-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other recalls by Guardian Drug Co. Inc.

All 2026 recalls
Class II · Moderate risk

TopCare health

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

Ongoing Particulate / foreign matter Guardian Drug Co. Inc. NDC 76162-129-68 D-0579-2026
Class II · Moderate risk

TopCare health

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

Ongoing Particulate / foreign matter Guardian Drug Co. Inc. NDC 76162-128-22 D-0578-2026

Other particulate / foreign matter recalls from 2026

All particulate / foreign matter recalls
Class I · High risk

Dextrose Injection

Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.

Ongoing Particulate / foreign matter Baxter Healthcare Corporation NDC 00338-0719-06 D-0850-2026