Formoterol Fumarate Inhalation Solution, 20mcg/2mL,… was recalled on October 15, 2026 in cooperation with the U.S. Food and Drug Administration because failed Impurities/Degradation Specification.
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
Lot: 25BL0, Expires: 02/28/2027
Units affected: 3210 Cartons
Where it was sold: Nationwide within the U.S
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Failed Impurities/Degradation Specification
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: The Ritedose Corporation
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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CGMP Deviations
Presence of Foreign Tablets/Capsules
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