THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN

Recall Insight

This FDA Drug action (record #D-0140-2021) was formally reported on December 23, 2020, with the manufacturer initiating the action on November 30, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Advanced Nutriceuticals, LLC is listed as the recalling firm, operating out of Indianapolis, IN. Federal records indicate 3 vials units are affected.

The documented reason for this recall is: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile. Distribution data in the federal record shows the product reached: CA, CO, FL, IN, KY, OH, TX. 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 6 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.