Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.

Recall Insight

This FDA Drug action (record #D-1078-2015) was formally reported on May 20, 2015, with the manufacturer initiating the action on April 24, 2015. It is classified under Low severity (Class III), with a current status of Terminated. Cipla Limited is listed as the recalling firm, operating out of Pithampur, District Dhar, N/A. Federal records indicate 140,625 Vials units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. Distribution data in the federal record shows the product reached: U.S. Nationwide including 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, 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.