Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05

Recall Insight

This FDA Drug action (record #D-1301-2014) was formally reported on May 14, 2014, with the manufacturer initiating the action on March 13, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Blu Pharmaceuticals Inc is listed as the recalling firm, operating out of Franklin, KY. Federal records indicate 14,000 tablets units are affected.

The documented reason for this recall is: Defective container: Product distributed without inner seal on bottles. Distribution data in the federal record shows the product reached: NJ, UT, IL 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, 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 12 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.