Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.

Recall Insight

This FDA Drug action (record #D-0649-2020) was formally reported on January 15, 2020, with the manufacturer initiating the action on January 7, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Appco Pharma LLC is listed as the recalling firm, operating out of Piscataway, NJ. Federal records indicate 624 bottes units are affected.

The documented reason for this recall is: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Distribution data in the federal record shows the product reached: Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.. 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.