FDA Recalls Alka-Seltzer Products for Sanitation Violations in Distribution Center
Gold Star Distribution Inc. is recalling Alka-Seltzer Original and Plus Cold & Flu products distributed nationwide due to insanitary conditions and documented rodent activity in their distribution facility.
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: This is an FDA Class II recall involving documented sanitation violations and rodent exposure in the distribution facility. While no illnesses or injuries have been reported, Class II classification indicates potential for serious adverse health effects, and the concrete contamination risk from rodent activity elevates this above low-risk scenarios.
Plain-English summary
Alka-Seltzer Original (2 tablets per packet in 58-count box) and Alka-Seltzer Plus Cold & Flu (2 tablets per packet in 36-count box) are being recalled due to sanitation violations at the distribution center.
The recall was issued because Gold Star Distribution Inc.'s distribution center failed to maintain proper sanitary conditions required by Current Good Manufacturing Practice (CGMP) standards. Rodent exposure and activity were documented in the facility. The recall applies to all lots within expiration date distributed by the company.
No illnesses or injuries have been reported. However, the documented rodent activity in the distribution center creates a potential risk of contamination to the products.
Consumers should stop using affected products and refer to the official FDA recall notice for specific UPC codes and product identification information.
The recalled product
- Product
- 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
- Manufacturer
- GOLD STAR DISTRIBUTION INC
- Category
- Drug
- Hazard
- rodent-contamination
- sanitation-violation
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 (1)
- All lots within expiry distributed by Gold Star Distribution.
Distribution
Distributed nationwide across the United States.
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