minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI Health, LLC 134 Columbus St. Charleston, SC 29403 USA. NDC 71403-102-05.

Recall Insight

This FDA Drug action (record #D-0120-2020) was formally reported on October 2, 2019, with the manufacturer initiating the action on August 26, 2019. It is classified under Low severity (Class III), with a current status of Terminated. EPI Health, LLC is listed as the recalling firm, operating out of Charleston, SC. Federal records indicate 1,626 5-count bottles units are affected.

The documented reason for this recall is: Failed Dissolution Specifications: Distribution data in the federal record shows the product reached: Firm recalling only from EPI Field Representatives.. 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 7 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.