Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.

Recall Insight

This FDA Drug action (record #D-1039-2017) was formally reported on August 9, 2017, with the manufacturer initiating the action on July 25, 2017. It is classified under Low severity (Class III), with a current status of Terminated. Teva Pharmaceuticals USA is listed as the recalling firm, operating out of North Wales, PA. Federal records indicate 401,750 cartons units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Failed Impurities/Degradation Specifications: high out of specification results for related compound D. Distribution data in the federal record shows the product reached: Nationwide in the USA and Puerto Rico. 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. 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 9 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.