Formoterol Fumarate Inhalation Solution Recalled Due to Failed Impurities Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for formoterol fumarate inhalation solution, 20 mcg/2mL. The affected batch has been identified as Lot 25BL0 (expires February 2027), containing 3210 cartons.
• The recall was initiated by the Ritedose Corporation due to the product’s failure to meet impurities specifications, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Formoterol inhalation is used to treat asthma and chronic obstructive pulmonary disease (COPD).

The FDA has issued a Class II recall for formoterol fumarate inhalation solution, 20 mcg/2mL, affecting 3210 cartons. This product is being recalled by the Ritedose Corporation based in Columbia, South Carolina. The recall was initiated on October 15, 2026, and received a Class II classification on October 23, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated after the product failed to meet impurities specifications. This issue affects Lot 25BL0, which will expire in February 2027. The Ritedose Corporation sent out a public notice via letter; no press release has been issued for this recall.

Formoterol inhalation is used to treat asthma and reduce air flow blockage in patients with COPD. Pharmacists should identify and quarantine Lot 25BL0, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. November 4, 2026. Accessed November 4, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=223372