Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2

Recall Insight

This FDA Drug action (record #D-1059-2014) was formally reported on February 12, 2014, with the manufacturer initiating the action on November 4, 2013. It is classified under Low severity (Class III), with a current status of Terminated. Greenstone Llc is listed as the recalling firm, operating out of Peapack, NJ. Federal records indicate 22,529 bottles units are affected.

The documented reason for this recall is: Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval Distribution data in the federal record shows the product reached: US Nationwide (including PR). 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.