TUMS Antacid Tablets Recalled for Glass Mineral Wool Contamination
GlaxoSmithKline is recalling TUMS Antacid 1000 mg chewable tablets in Assorted Berries flavor due to glass mineral wool contamination found in some bottles. Product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This recall scores High (3) as a risk-of-harm product involving glass mineral wool contamination in a chewable medication, with no reported illnesses or injuries in the source. FDA Class II recalls require documented hospitalizations to reach Severe (4), which is not present.
Plain-English summary
GlaxoSmithKline Consumer Healthcare Holdings LLC is recalling TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets because some bottles contain glass mineral wool.
The recalled product is packaged in 265-count bottles with the following identification: NDC 135-0181-05, UPC 3-0766-3072-14-7. The affected lot numbers are J96X and J96W, which expire on 09/30/2027. This product was distributed nationwide throughout the United States.
Consumers who have purchased this product should stop using it and contact GlaxoSmithKline Consumer Healthcare Holdings LLC or speak with a healthcare provider if they have questions or concerns.
The recalled product
- Product
- TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7
- Manufacturer
- GlaxoSmithKline Consumer Healthcare Holdings LLC
- Category
- Drug — Antacid
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 (3)
- Lot #: J96X
- J96W
- Exp. Date 09/30/2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by GlaxoSmithKline Consumer Healthcare Holdings LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
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See all →- HighTUMS Antacid Tablets Recalled for Glass Mineral Wool Contamination
FDA (Drugs) · 2023-11-08
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