Food, drugs, devices › GOLD STAR DISTRIBUTION INC
Drug recall: Advil a) Ibuprofen, Dispenser Pack, 2 tablet packets in box containing 50 individual packets, UPC: 305730154895; b) PM,
GOLD STAR DISTRIBUTION INC (Minneapolis, MN) initiated this drug recall on 26 Dec 2025; FDA lists 27 product records under event 98239, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 79% of the 322 drug enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. GOLD STAR DISTRIBUTION INC has 3 enforcement events on this register, with a median of 5 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GOLD STAR DISTRIBUTION INC, Minneapolis, MN.
Reason for recall
"CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center."
Distribution
"US Nationwide."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0261-2026 | 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 | Unkown | Class II | Ongoing | 21 Jan 2026 |
| D-0262-2026 | Aleve 1's, 60 CT | — | Class II | Ongoing | 21 Jan 2026 |
| D-0263-2026 | Alka Seltzer, a) Original, 2 tablets per packet in 58 count box, UPC: 815556020033, 016500514473, b) Plus Cold & Flu, 2 tablets per packet in 36 count box, UPC: 016500594932 | Unknown | Class II | Ongoing | 21 Jan 2026 |
| D-0264-2026 | Benadryl, 25'S 2PK Box, UPC 815556020316 | — | Class II | Ongoing | 21 Jan 2026 |
| D-0265-2026 | Bayer 2Pk- 25 CT | — | Class II | Ongoing | 21 Jan 2026 |
| D-0266-2026 | Claritin, 20 Count, UPC: 655708016305 | Unknown | Class II | Ongoing | 21 Jan 2026 |
| D-0267-2026 | DAYQUIL COLD & FLU, 32CT/2PK | Unknown | Class II | Ongoing | 21 Jan 2026 |
| D-0268-2026 | LIQUID DAYQUIL 12/8oz | — | Class II | Ongoing | 21 Jan 2026 |
| D-0269-2026 | EXCEDRIN 2'S DISP.- 30 CT | — | Class II | Ongoing | 21 Jan 2026 |
| D-0270-2026 | EXCEDRIN MIGRAINE 2'S- 25 CT | — | Class II | Ongoing | 21 Jan 2026 |
| D-0271-2026 | MOTRIN 2'S DISP.- 50CT | — | Class II | Ongoing | 21 Jan 2026 |
| D-0272-2026 | LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz | — | Class II | Ongoing | 21 Jan 2026 |
| D-0273-2026 | NYQUIL COLD & FLU -32CT/2PK | — | Class II | Ongoing | 21 Jan 2026 |
| D-0274-2026 | CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct | — | Class II | Ongoing | 21 Jan 2026 |
| D-0275-2026 | PEPTO BISMOL 32CT | — | Class II | Ongoing | 21 Jan 2026 |
| D-0276-2026 | PEPCID COMPLETE - 25CT | — | Class II | Ongoing | 21 Jan 2026 |
| D-0277-2026 | 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 | — | Class II | Ongoing | 21 Jan 2026 |
| D-0278-2026 | 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… | — | Class II | Ongoing | 21 Jan 2026 |
| D-0279-2026 | 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 | — | Class II | Ongoing | 21 Jan 2026 |
| D-0280-2026 | Swan, White Clear Alcohol, 50%, 16oz, 12 count | Unknown | Class II | Ongoing | 21 Jan 2026 |
| D-0281-2026 | Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463 | Unknown | Class II | Ongoing | 21 Jan 2026 |
| D-0282-2026 | Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148 | Unknown | Class II | Ongoing | 21 Jan 2026 |
| D-0283-2026 | Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319 | Unknown | Class II | Ongoing | 21 Jan 2026 |
| D-0284-2026 | LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989 | Unknown | Class II | Ongoing | 21 Jan 2026 |
| D-0285-2026 | Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC:… | Unknown | Class II | Ongoing | 21 Jan 2026 |
| D-0286-2026 | Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808829089103; d) LADY DEODORANT, CHERRY BLOSSOSM, 24CT, 1.8oz, UPC: 048155921092; e) AXE, BODY SPRAY,… | — | Class II | Ongoing | 21 Jan 2026 |
| D-0287-2026 | Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE, TOOTHPASTE, MINT ZING, 24CT, 2.5oz, UPC: 035000744609; COLGATE, MAXFRESH, SPICY FRESH, RED TOOTH… | — | Class II | Ongoing | 21 Jan 2026 |
Context
Other enforcement events for GOLD STAR DISTRIBUTION INC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 26 Dec 2025 | Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT | Device | Class II | 5 |
| 26 Dec 2025 | All human food products distributed from the firm. Including but not limited to: snack foods, candy, gum, cooking oil, c | Food | Class II | 1 |
All 3 events for GOLD STAR DISTRIBUTION INC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.