Extra Strength Antacid Calcium Carbonate Recalled Due to Foreign Contamination

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for extra strength antacid calcium carbonate, 750 mg. The affected batch has been identified as Lot 1276118 (expires January 2029).
• The recall was initiated by Guardian Drug Co, Inc due to the presence of a foreign substance, a quality issue that may cause temporary or medically reversible adverse health consequences.
• Calcium carbonate is used to treat heartburn, indigestion, and upset stomachs. It can also be used to increase the amount of calcium in the body.

The FDA has issued a Class II recall for extra strength antacid calcium carbonate, 750 mg. This medication is being recalled by Guardian Drug Co, Inc based in Dayton, New Jersey. The recall was initiated on May 28, 2026, and received a Class II classification on June 3, 2026.

The recall was initiated due to the presence of a foreign substance—metallic particles were found in the product. This deficiency affects Lot 1276118, which will expire in January 2029. A Class II classification means the use of this product may cause temporary or medically reversible adverse health consequences, or it has a low probability of causing serious adverse health consequences. Guardian Drug Co sent out a public notice via letter; no public press release has been issued for this recall.

Calcium carbonate is an over-the-counter medication used to treat heartburn, indigestion, and upset stomach by reducing stomach acid. It can also be used as a dietary supplement to increase bodily calcium levels. Pharmacists should identify and quarantine Lot 1276118, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. June 10, 2026. Accessed June 10, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=220789