FDA Drugs recall ·
TYLENOL a) 500 MG., 2'S DISPLAY, 50CT recall
- Recall number
- D-0277-2026
- Date
- (initiated December 26, 2025)
- Company / brand
- Gold Star Distribution Inc
1000 Humboldt Ave N, Minneapolis, MN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All lots within expiry distributed by Gold Star Distribution.
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0277-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.