FDA-Drug2026-10-23Class IICHEMICAL
Ritedose Formoterol Fumarate inhalation solution recalled for failed impurities specification
What this means
Ritedose Pharmaceuticals recalled one lot of Formoterol Fumarate Inhalation Solution (20mcg/2mL) because it failed quality testing for impurities and degradation. The affected lot (25BL0, expiring 02/28/2027) was distributed nationwide. No injuries have been reported.
- If you have this medication, check the lot number on your carton against lot 25BL0.
- Contact your pharmacy or prescriber if you have the recalled lot.
- Do not use the medication from the recalled lot; return it to your pharmacy.
The agency's original wording
Hazard
Failed Impurities/Degradation Specification
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
3210 Cartons
Manufactured in
1 Technology Cir, Columbia, South Carolina, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0073-2027Want us to check the next one for you?
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