J-TAN D PD Drops (bromphenirame maleate 1 mg and pseudoephedrine hcl 7.5 mg/ teaspoon), 1 fl oz (30 mL) Bottle, Over the Counter. Manufactured for JayMac Pharmaceuticals, LLC, Sunset, LA; Manufactured by Sonar Products Inc., Carlstadt, NJ, NDC: 64661-032-30.

Recall Insight

This FDA Drug action (record #D-0327-2015) was formally reported on January 7, 2015, with the manufacturer initiating the action on December 16, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Jaymac Pharmaceuticals L.L.C. is listed as the recalling firm, operating out of Sunset, LA. Federal records indicate 5572 Bottles units are affected.

The documented reason for this recall is: Labeling: Not Elsewhere Classified: Product is labeled "Dye Free" on front panel but contains Red Dye 40. Distribution data in the federal record shows the product reached: U.S. including: LA, AR, TX, MS. 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.