What contaminated it was coolant from the packaging machine — 44 days is the median to reporting (Gas-X)

1Not the medicine, but the packaging line

What caused contamination here was neither the active ingredient nor a raw material, but coolant that leaked from a machine used in packaging. The FDA record is specific: a diluted propylene glycol-based coolant.

Pharmaceutical quality control tends to evoke the drug substance and formulation steps, but packaging and filling also touch the product directly, which puts the lubricants and coolants used there under control as well. This case is one where a leak at that stage reached the finished product.

2What over-the-counter distribution means

The product is an over-the-counter medicine sold without a prescription, and two pack sizes are listed. OTC products move through pharmacies, mass retailers, and online sellers, and often leave no record of who bought them — a major difference from prescription drugs. That 35,883 cartons went nationwide means there are limited means of getting a recall notice to each individual holder.

3Checking by UPC

The FDA record gives a UPC (the retail barcode number) for each pack size. For an OTC product sold in several sizes under one brand name, the name alone cannot tell you whether a package is affected. The reliable check is to match the UPC on the package against the record: 3 00674 35041 9 for the 120-softgel pack and 3 00439 00572 1 for the 72-softgel pack.

4From the start of a recall to its appearance in the record

Across the 1,408 FDA recall records this site holds as of 2026-09-01, the days between the firm beginning a recall and the report date run to a median of 44. The shortest is 7 days, the longest 1,133, and 100 records exceed 90 days.

This record was initiated on 2026-06-04 and reported on 2026-06-17 — 13 days, among the faster ones. By the time a recall reaches the public record it has usually been in motion for over a month, so reading the record date as the start of events misplaces what happened.