Benadryl 25'S 2PK Recalled Due to Distribution Center Insanitary Conditions
Benadryl 25'S 2PK boxes are being recalled nationwide due to insanitary conditions and rodent exposure in the distribution center. Affected consumers should stop using these products.
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 FDA Class II recall qualifies as High severity because it represents a potential contamination risk from insanitary conditions and rodent exposure without any reported illnesses or injuries, meeting the rubric criterion for risk-of-harm products where injury has not been reported.
Plain-English summary
Benadryl 25'S 2PK boxes (UPC 815556020316) manufactured by Gold Star Distribution Inc are being recalled. The recall was issued because of Current Good Manufacturing Practice (CGMP) deviations, specifically insanitary conditions and rodent exposure/activity in the distribution facility. The FDA has classified this as a Class II recall.
The recalled product includes all lots within their expiration date that were distributed by Gold Star Distribution. The affected product has been distributed nationwide in the United States.
Consumers who have purchased this product should stop using it. Consumers should contact their healthcare provider or pharmacist for guidance on disposing of the product and for information about alternative treatment options.
The recalled product
- Product
- Benadryl, 25'S 2PK Box, UPC 815556020316
- Manufacturer
- GOLD STAR DISTRIBUTION INC
- Category
- Drug
- Hazard
- insanitary-conditions
- rodent-exposure
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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