Product: 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
Reason for recall: Failed Stability Specification and Failed Impurities/Degradation Specifications:  out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Recall initiated: 20230623
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated