Gas-X Extra Strength softgels contaminated with propylene glycol machine coolant
Gas-X Extra Strength simethicone 125 mg softgels are being recalled because of contamination with a diluted propylene glycol-based coolant leaked from a machine during packaging.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
Gas-X Extra Strength, simethicone 125 mg antigas, in 120-softgel packs (UPC 3 00674 35041 9) and 72-softgel packs (UPC 3 00439 00572 1), distributed by Haleon of Warren, New Jersey, is being recalled. The action covers 35,883 boxes.
The stated reason is chemical contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. The FDA classified the action as Class I, its most serious classification.
Affected lots are TL8K, YH9X and YH9Y for the 120-count pack and X78N for the 72-count pack, all expiring 30 Nov 2028. Distribution was nationwide within the United States.
Consumers who have an affected lot should stop using it and return it to the place of purchase. Anyone who has taken it and feels unwell should seek medical advice.
The recalled product
- Product
- Gas-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.
- Manufacturer
- Haleon US Holdings LLC
- Category
- Drug — Antigas softgel
- Affected units
- 35,883
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lots: a) TL8K
- YH9X
- YH9Y
- Exp. Date. 30Nov2028
- b) X78N
- Exp. Date 30Nov2028.
Distribution
Distributed nationwide across the United States.
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