KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.

Recall Insight

This FDA Drug action (record #D-0148-2017) was formally reported on November 30, 2016, with the manufacturer initiating the action on October 28, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Sun Pharmaceutical Industries, Inc. is listed as the recalling firm, operating out of Cranbury, NJ. Federal records indicate 326,103 bottles units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Failed Stability Specifications: Low Out of Specification results for alcohol content. Distribution data in the federal record shows the product reached: NJ and further distributed Nationwide in the USA.. 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 10 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.