Class II U.S. Food and Drug Administration

Gold Star Distribution Inc Advil a) Ibuprofen, Dispenser Pack recall: CGMP Deviations: Insanitary conditions including rodent exposure/activity

Recall published 9 months ago

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

The hazard: Labelling or manufacturing-practice failure

A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

What the notice says: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0261-2026
Published
January 21, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Gold Star Distribution Inc
Product type
Prescription & OTC drugs
Units affected
Unkown
Distribution
Nationwide
Made in
United States
Lot / code info
All lots within expiry distributed by Gold Star Distribution.
UPC codes
305730154895, 305730164559

Products covered by this recall

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

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 305730154895
  • 305730164559

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Labelling

Gold Star Distribution Inc — A labelling or good-manufacturing-practice failure prompted this notice. Pharmacies and patients both rely on the printed carton being right.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.
  3. If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.
  4. Keep taking the medicine as prescribed unless the notice or your prescriber says otherwise.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: GOLD STAR DISTRIBUTION INC — 1000 Humboldt Ave N, Minneapolis, MN, 55411-3964

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Gold Star Distribution Inc prescription & otc drugs recalled?

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 305730154895, 305730164559. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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