TYLENOL pain relievers recalled for rodent contamination at distributor
Gold Star Distribution is recalling multiple TYLENOL formulations due to insanitary conditions, including rodent exposure and activity in its distribution center. All lots within expiry are affected.
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: FDA Class II recall involving contamination risk from insanitary conditions and rodent exposure at a distribution facility. No illnesses or injuries have been reported, making this a precautionary recall of high-risk products before harm occurs.
Plain-English summary
Gold Star Distribution Inc is recalling multiple TYLENOL formulations due to Current Good Manufacturing Practice (CGMP) deviations at the distributor's facility. The affected products include 500 MG 2's Display 50 count, Cold & Flu 25 count/2s, Cold & Flu Severe 2 pack 50 count, PM 50 count, and Sinus Severe 2 pack 50 count.
The recall was initiated due to insanitary conditions found in the distribution center, including rodent exposure and activity. These conditions create a potential contamination risk to the distributed products.
The affected products were distributed nationwide. All lot numbers within their expiration date distributed by Gold Star Distribution are included in this recall.
The recalled product
- Product
- TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT
- Manufacturer
- GOLD STAR DISTRIBUTION INC
- Hazard
- insanitary-conditions
- rodent-contamination
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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