Advil Ibuprofen Dispenser Packs Recalled for Rodent Contamination Risk
Gold Star Distribution Inc. is recalling Advil Ibuprofen and PM dispenser packs distributed nationwide due to insanitary conditions and rodent exposure in the distribution center.
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 with documented CGMP deviations including insanitary conditions and rodent exposure. This represents a risk of harm from potential pathogenic contamination. No illnesses or injuries have been reported, which per the rubric limits the score to 3 for risk-of-harm products without reported injury.
Plain-English summary
Gold Star Distribution Inc. is recalling Advil Ibuprofen Dispenser Pack (50-packet boxes, UPC 305730154895) and Advil PM Ibuprofen Dispenser Pack (50-packet boxes, UPC 305730164559) that were distributed nationwide. The recall affects all lots within their expiration date.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically insanitary conditions and evidence of rodent exposure and activity in the distribution center. Rodent contamination poses a risk of pathogenic contamination.
If you have purchased either product, do not use it. Dispose of the product according to FDA guidelines, or return it to the place of purchase. Consumers with questions about this recall should contact the recalling firm or the FDA.
The recalled product
- Product
- Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM, Ibuprofen, Dispenser Pack, 2 Caplet packets in box containing 50 packets, UPC: 305730164559
- Manufacturer
- GOLD STAR DISTRIBUTION INC
- Hazard
- rodent-exposure
- insanitary-conditions
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.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27