FDA recall, , Moderate risk
Gold Star Distribution Advil, Aleve, Tylenol and More Over-the-Counter Medicines
Gold Star Distribution medicines have CGMP deviations.
Summary by Recall Canary from the FDA notice
What happened
Gold Star Distribution Inc of Minneapolis, Minnesota recalled products because of CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. The recall began December 26, 2025, was added to the FDA's Enforcement Report January 14, 2026, and was classified by the FDA on January 14, 2026. Distribution was US Nationwide.
17 photos
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UPC is the number printed under a barcode.
Tylenol a)
- Strength
- 500 mg
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Children Nyquil, Cold&FLU, Berry, 8oz, 12ct
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Swan, White Clear Alcohol, 50%, 16oz, 12 count
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Benadryl, 25'S 2PK Box
- UPC
- 815556020316
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Bayer 2Pk- 25 CT
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Excedrin 2'S Disp.- 30 ct
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Pepcid Complete - 25CT
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Motrin 2'S Disp.- 50CT
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Nyquil Cold & FLU -32CT/2PK
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Show the other 17 products
Carmex a) jar, 12 count
- UPC
- 083078123154
- 083078123147
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Product details
Halls Cough Drops a) BAGS, MENTHOL, 12CT;
b) BAGS, HONEY LEM, 12CT;
c) BAGS, DEFENSE CITRUS, 12CT;
d) BAGS, CHERRY, 12CT;
e) M. CHERRY, 20 STK;
f) BRAZIL, Cherry, 21CT/27.5G;
f) LEMON. HONEY, 20CT #1180E;
g) LIME FRESH, 20CT, #1182;
h) MENTHOL BLUE, 20CT, #1180A;
i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK;
k) DEFENSE, VITAMIN C, 20CT, #1181- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Pepto Bismol 32CT
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Personal Care, Ice Gel, 8oz, 12 count
- UPC
- 048155903463
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Dayquil Cold & FLU, 32CT/2PK
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Alka Seltzer, a) Original, 2 tablets per packet in 58 count box
- UPC
- 815556020033
- 016500594932
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Excedrin Migraine 2'S- 25 ct
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Aleve 1's, 60 CT
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Toothpaste: a) Colgate, Toothpaste, Whitening, 2.5oz, 24ct
- UPC
- 035000511065
- 035000511058
- 035000512109
- 035000744609
- 037000247081
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Liquid Dayquil 12/8oz
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML
- UPC
- 600108736469
- 808829111668
- 808829089103
- 048155921092
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Claritin, 20 Count
- UPC
- 655708016305
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Liquid Nyquil a) regular, 12/8oz; b) cherry, 12/8oz
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Personal Care, Vaporizing Chest Rub, 4 oz, 12 count
- UPC
- 048155903319
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT
- UPC
- 6001085120946
- 60022141
- 6001085121028
- 60022127
- 808829081466
- 808829081572
- 048155908642
- 048155922242
- 096002007208
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Lucky Ice, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT
- UPC
- 808829108989
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets
- UPC
- 305730154895
- 305730164559
- Lot code
- All lots within expiry distributed by Gold Star Distribution.
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- GOLD STAR DISTRIBUTION INCMinneapolis, Minnesota
- Hazard
- Manufacturing problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98239
- Recall numbers
- D-0261-2026 to D-0287-2026
All recalls from GOLD STAR DISTRIBUTION INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
