FDA-Drug2026-01-21Class IIPROCESSING DEFECT

Alka-Seltzer Original and Plus Cold & Flu recalled for rodent contamination at distributor

Nationwide distributionDrugs

What this means

Alka-Seltzer Original (58-count boxes) and Plus Cold & Flu (36-count boxes) distributed by Gold Star Distribution Inc. were stored in conditions with rodent exposure and activity. The FDA found unsanitary conditions at the distribution center that do not meet manufacturing safety standards.

  • Check your Alka-Seltzer boxes for the affected UPCs: 815556020033, 016500514473 (Original) or 016500594932 (Plus Cold & Flu)
  • Do not use affected products; dispose of them
  • Contact Gold Star Distribution or the FDA if you have questions about whether your product is affected
The agency's original wording
Hazard

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

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
Unknown
Manufactured in
1000 Humboldt Ave N, Minneapolis, MN, United States
Products
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932

UPC codes

  • 815556020033
  • 016500514473
  • 016500594932

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0263-2026

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