June 2023 FDA Recall Tydemy by Lupin Pharmaceuticals Inc.
D-1081-2023 - Failed Stability Specification and Failed Impurities/Degradation Specifications

This Class I drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on June 23, 2023 for the product Tydemy. The FDA reported the reason for recall as failed stability specification and failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1081-2023

Reason for Recall
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Initiated
06-23-2023
Reported
08-09-2023
Quantity
4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92588
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-28-2025
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : L200183, Exp 1/2024; L201560, Exp 9/2024

Affected Packages Involved in this Recall

68180-904-73 Tydemy
68180-904-71 Tydemy