Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA

Recall Insight

This FDA Drug action (record #D-1081-2023) was formally reported on August 9, 2023, with the manufacturer initiating the action on June 23, 2023. It is classified under Critical severity (Class I), with a current status of Terminated. Lupin Pharmaceuticals Inc. is listed as the recalling firm, operating out of Baltimore, MD. Federal records indicate 4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test Distribution data in the federal record shows the product reached: USA nationwide.. 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 3 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.