FlaggedRx← Medication recall checkHome
Class III · Lower riskRecall completed

Tydemy (drospirenone

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: L000784 and L000785, Exp. Date May 2022
Where it was soldnationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Subpotent Drug

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet foreign manufacturer
Distributed by / forLupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated
NDC68180-904-11
Show the full FDA record
Full product labelTydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated, Manufactured by: Lupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13.
Recalling firmLupin Pharmaceuticals Inc.
Distributionnationwide within the United States
Quantity4113 cartons
Recall initiated2021-11-19
Report date2021-12-08
Recall completed2022-11-15
Recall numberD-0264-2022
ClassificationClass III
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.