Advil a) Ibuprofen recall
FDA recall D-0261-2026 · initiated Dec 26, 2025
GOLD STAR DISTRIBUTION INC recalled Advil a) Ibuprofen in Dec 2025 — an FDA Class II recall (D-0261-2026) because CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: Unkown
Details
- 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
- Recalling company
- GOLD STAR DISTRIBUTION INC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Dec 26, 2025
- FDA report date
- Jan 21, 2026
Frequently asked
- Was Advil a) Ibuprofen recalled?
- GOLD STAR DISTRIBUTION INC recalled Advil a) Ibuprofen in Dec 2025 — an FDA Class II recall (D-0261-2026) because CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Advil a) Ibuprofen recalled?
- Per the FDA enforcement record, the reason for recall D-0261-2026 was: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- Is a recalled Advil a) Ibuprofen dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Advil a) Ibuprofen are affected?
- Distributed: US Nationwide.. The recall covers these lots — All lots within expiry distributed by Gold Star Distribution.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0261-2026.