fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01

Recall Insight

This FDA Drug action (record #D-0225-2025) was formally reported on February 26, 2025, with the manufacturer initiating the action on January 31, 2025. It is classified under Moderate severity (Class II), with a current status of Completed. Fagron Compounding Services is listed as the recalling firm, operating out of Wichita, KS. Federal records indicate 1330 bags units are affected.

The documented reason for this recall is: Lack of Assurance of Sterility Distribution data in the federal record shows the product reached: Distributed in PA. 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 1 year 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.