The Ritedose Corporation: Formoterol Fumarate Inhalation Solution, 20mcg/2ml

Recall Summary Ritedose Corporation is recalling Formoterol Fumarate Inhalation Solution (20mcg/2mL) sold in cartons of 30 or 60 vials because the product failed quality testing for impurities and degradation. The affected medication was distributed nationwide across all U.S. states and Washington, D.C. This is a prescription-only inhalation drug used by patients who have the product in their possession or healthcare facilities that may have received it.

Recalling firm

The Ritedose Corporation

Product

Formoterol Fumarate Inhalation Solution, 20mcg/2mL, packaged in cartons of 30 individually wrapped vials (NDC 76204-030-01) and 60 individually wrapped vials (NDC 76204-030-02), Rx only, Manufactured for and by: Ritedose Pharmaceuticals, LLC, Columbia, SC

Reason

Failed Impurities/Degradation Specification

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-10-15

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide within the U.S

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/e2802246-a11f-425d-ad7b-688ed733092e