The Recall Desk
HighFDA (Drugs)·D-0079-2024·Announced 2023-11-08

TUMS Antacid Recalled for Glass Mineral Wool Contamination

GlaxoSmithKline is recalling TUMS antacid tablets in Lot KH5L due to glass mineral wool contamination. Affected consumers should stop use immediately.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for physical contamination (glass mineral wool) in a chewable antacid. This qualifies as a risk-of-harm product where injury has not yet been reported, matching the High severity criterion.

Plain-English summary

GlaxoSmithKline Consumer Healthcare Holdings LLC is recalling TUMS Antacid (Calcium Carbonate USP 1000 mg) tablets in Assorted Berries flavor due to contamination with a foreign substance comprised primarily of glass mineral wool.

The affected product is a 72-count bottle with NDC 0135-0118-83, UPC 3-0766-0746-50-8, Lot# KH5L, expiration date 09/30/2027. The product was distributed nationwide within the United States.

Consumers who have purchased the affected lot should discontinue use immediately.

The recalled product

Product
TUMS (CALCIUM CARBONATE)
Brand
TUMS
Manufacturer
GlaxoSmithKline Consumer Healthcare Holdings LLC
Hazard
  • glass-contamination
  • choking

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot#: KH5L
  • Exp. Date 09/30/2027

UPCs (1)

  • 307660746508

Distribution

Distributed nationwide across the United States.