Quality & complianceOfficial

FDA classifies Ritedose formoterol inhalation solution recall as Class II over impurity failure

🇺🇸 FDA enforcement report · Wed 04 Nov 2026

The Ritedose Corporation's nationwide US recall of Formoterol Fumarate Inhalation Solution, listed as ongoing, stems from a failed impurities/degradation specification, according to the FDA enforcement report.

The US Food and Drug Administration has listed a Class II recall of Formoterol Fumarate Inhalation Solution made by The Ritedose Corporation, in its enforcement report dated 4 November 2026. The recall is numbered D-0073-2027.

The stated reason is a failed impurities/degradation specification. In practice, this means the product did not meet the limits set for impurities or degradation products.

The FDA records the recall as ongoing, with distribution nationwide within the United States.

The text available to us contains only the enforcement report's search-page navigation. It does not give lot numbers, expiry dates, quantities or the date the recall began, so we cannot report those details. We also cannot say whether any adverse events have been reported.

By way of context, the FDA uses Class II for recalls where use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote.

What it means for your team

  • Quality teams should check the full FDA enforcement entry for D-0073-2027 for affected lots and codes, as these are not in the material reviewed here.
  • Supply-chain and pharmacy contacts handling formoterol inhalation solution in the US may need to verify stock against the recall details.
  • Pharmacovigilance teams may wish to watch for any complaint or adverse event reports linked to this product, though none are cited in the source.
  • Impurity and degradation failures are a reminder to review stability and release-testing trends for inhalation products.

Official source: FDA enforcement report ↗

Article written by VigiEye from the official source (FDA enforcement report). AI-assisted; check the source before acting.

More Quality & compliance All →