FDAAugust 5, 2025drug
Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
What to do
FDA enforcement status: Ongoing
Brands named
haleon
UPCs
310158356912
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAGas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.2026-06-04
- FDAGas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.2026-05-11
- FDAparodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-022025-12-26
- FDARobitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 070592023-12-26
- FDARobitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 070592023-12-26
- FDAAdvil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Pfizer, Madison, NJ 07940, UPC 3 0573 1769 13 52022-12-06
- FDAAdvil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Distributed by: Pfizer, Madison, NJ 07940, UPC 3 0573 0169 49 32022-12-06
- FDAAdvil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UPC 3 0573 0154 21 5), Pfizer, Madison, NJ 079402022-12-06
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