FDA recall, , Moderate risk
Ritedose Formoterol Fumarate Inhalation Solution
Formoterol Fumarate Inhalation Solution failed impurities and degradation specifications.
Summary by Recall Canary from the FDA notice
What happened
The Ritedose Corporation is recalling Formoterol Fumarate Inhalation Solution, 20mcg/2mL, packaged in cartons of 30 and 60 individually wrapped vials, because it failed impurities and degradation specifications. The product is Rx only, manufactured for and by Ritedose Pharmaceuticals, LLC, of Columbia, SC, and was distributed nationwide within the U.S. The recall began on October 15, 2026, and was added to the FDA's Enforcement Report on October 23, 2026. The recall involves 3,210 cartons.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Formoterol Fumarate Inhalation Solution
- NDC
- 76204-030-01
- 76204-030-02
- Lot code
- 25BL0
Recall details
- Company began the recall
- Sold in
Nationwide within the U.S
- Company
- The Ritedose Corporation
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 100124
- Recall number
- D-0073-2027
- Quantity recalled
- 3210 Cartons
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
