Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03

Recall Insight

This FDA Drug action (record #D-0505-2024) was formally reported on May 29, 2024, with the manufacturer initiating the action on May 10, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Preferred Pharmaceuticals, Inc. is listed as the recalling firm, operating out of Anaheim, CA. Federal records indicate 66 bottles of 30 tablets units are affected.

The documented reason for this recall is: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Distribution data in the federal record shows the product reached: Product distributed to CA, FL, OK, KS and CT. 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 2 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.