FDA Drug recall D-0595-2026
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), D…
- FDA Drug
- Class I
- ongoing
- Published 2026-06-17
On 2026-06-17 the FDA classified a Class I recall of 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), D… by Haleon Us Holdings, citing chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0595-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-06-04 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Haleon Us Holdings |
| Distribution | US |
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.
Reason
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Identifiers
| upc | 300674350419 |
|---|---|
| upc | 300439005721 |
| code_info | Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0595-2026%22
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