TUMS Antacid Recalled for Glass Mineral Wool Contamination
GlaxoSmithKline is recalling TUMS Antacid (1000mg Calcium Carbonate) due to the presence of glass mineral wool. The affected lot (HV6B) 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: FDA Class II recall for confirmed physical contamination with glass mineral wool, a hazard presenting a risk of choking and internal injury. No illnesses or injuries have been reported.
Plain-English summary
GlaxoSmithKline Consumer Healthcare Holdings LLC is recalling TUMS Antacid Calcium Carbonate USP 1000 mg in Assorted Fruit flavor, packaged in 160-count bottles (NDC 0135-0118-14), due to the presence of a foreign substance primarily comprised of glass mineral wool.
The glass mineral wool contamination poses a potential risk of harm to consumers. Glass particles can cause choking, cuts to the mouth and throat, and internal injury when ingested.
The affected lot is HV6B with an expiration date of 9/30/2027, distributed nationwide within the United States. Consumers who have purchased this product should stop taking it and consult their healthcare provider if they have concerns.
The recalled product
- Product
- TUMS (CALCIUM CARBONATE)
- Brand
- TUMS
- Manufacturer
- GlaxoSmithKline Consumer Healthcare Holdings LLC
- Category
- Drug — Over-the-Counter 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 (2)
- Lot #: HV6B
- Exp. Date 9/30/2027
UPCs (1)
- 307660746102
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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Same manufacturer · GlaxoSmithKline Consumer Healthcare Holdings LLC
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