Estradiol Micronized Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-001-01) (44132-001-06)

Recall Insight

This FDA Drug action (record #D-0654-2017) was formally reported on April 19, 2017, with the manufacturer initiating the action on March 24, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Qinhuangdao Zizhu Pharmaceutical, Co. is listed as the recalling firm, operating out of Qinhuangdao, N/A. Federal records indicate N/A units are affected.

The documented reason for this recall is: cGMP Deviations; lack of quality assurance. Distribution data in the federal record shows the product reached: Product distributed to NY, TX, SC, CO, MN and NJ. 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 9 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.