Formoterol Fumarate Inhalation Solution recall (The Ritedose Corporation)
DrugClass IIOngoing
Summary: The Ritedose Corporation is recalling 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.
What is being recalled
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
Why
Failed Impurities/Degradation Specification
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the U.S
How to tell if yours is affected
Lot: 25BL0, Expires: 02/28/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0073-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | October 15, 2026 |
| Reported | November 4, 2026 |
| Company | The Ritedose Corporation |
| Company location | Columbia, SC, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3210 Cartons |
More recalls from The Ritedose Corporation · all drug recalls · recalls from October 2026