CLASS II ONGOING Drug recall · Reported 21 Jan 2026 · FDA Enforcement Report
Tylenol a) 500 MG., 2'S Display recalled by Gold Star Distribution
Gold Star Distribution is recalling Tylenol a) 500 MG., 2'S Display, distributed nationwide in the US. The recall was initiated on 26 Dec 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0277-2026
- FDA event ID
- 98239
- Recalling firm
- Gold Star Distribution, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Dec 2025
- FDA classified
- 14 Jan 2026
- Reported
- 21 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Drug class
- Cold & Cough Medicine
Timeline
| 26 Dec 2025 | Recall initiated by company | |
| 14 Jan 2026 | Classified by FDA | +19 days |
| 21 Jan 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Which lots are affected?
All lots within expiry distributed by Gold Star Distribution.
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
26 other products · FDA event 98239More recalls from Gold Star Distribution
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Bandages and first aid kits: First Aid Kit 24/42PC recalled | Gold Star Distribution | Foreign Material | Nationwide |
| Device | CLASS II | Pregnancy Test recalled by Gold Star Distribution | Gold Star Distribution | Foreign Material | Nationwide |
| Device | CLASS II | Condoms, labeled as: Trojan Magnum Condoms 6/Dsp Black recalled | Gold Star Distribution | Foreign Material | Nationwide |
| Device | CLASS II | Toothbrushes, labeled as: Oral B Tooth Brush Shiny Clean Soft recalled | Gold Star Distribution | Foreign Material | Nationwide |
| Device | CLASS II | Feminine hygiene products, labeled as recalled by Gold Star Distribution | Gold Star Distribution | Foreign Material | Nationwide |