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
- Category
- Drug — Antacid
- 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.
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- HighTUMS Antacid Recalled for Glass Mineral Wool Contamination
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- HighTUMS antacid tablets recalled due to glass mineral wool contamination
FDA (Drugs) · 2023-11-08
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