Bulk 9730 BIOSANLABS GLUTENEZYME capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103).

Recall Insight

This FDA Food action (record #F-0767-2014) was formally reported on December 25, 2013, with the manufacturer initiating the action on October 30, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. National Enzyme Co is listed as the recalling firm, operating out of Forsyth, MO. Federal records indicate 835,013 bulk capsules units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol Distribution data in the federal record shows the product reached: Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Nor…. 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 13 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.