Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland.

Recall Insight

This FDA Drug action (record #D-1138-2015) was formally reported on June 24, 2015, with the manufacturer initiating the action on May 22, 2015. It is classified under Low severity (Class III), with a current status of Terminated. Novartis Pharmaceuticals Corp. is listed as the recalling firm, operating out of Suffern, NY. Federal records indicate 55,442 packs units are affected.

The documented reason for this recall is: Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. Distribution data in the federal record shows the product reached: NJ via 1 distributor. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.