Drug FDA Class II Ongoing cGMP deviation

TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A 05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C 03/27

GOLD STAR DISTRIBUTION INC Published Jan 21, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact GOLD STAR DISTRIBUTION INC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

Hazards

Rodent Contamination from Insanitary Conditions · primary

Affected products (1)

TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27

Lot codes: within

Code info: All lots within expiry distributed by Gold Star Distribution.

Affected areas

Nationwide

Timeline

Initiated

Dec 26, 2025
Published

Jan 21, 2026

Recall number: D-0279-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.