The Recall Desk
LowFDA (Drugs)·D-0264-2022·Announced 2021-12-08

Tydemy Oral Contraceptive Recalled Due to Subpotent Drug

Lupin Pharmaceuticals has recalled Tydemy oral contraceptive tablets nationwide due to subpotency. The recall affects 4,113 cartons distributed throughout the United States.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall initiated voluntarily by the firm with no reported illnesses or injuries. The hazard is subpotency, a manufacturing defect with theoretical impact rather than demonstrated harm, meeting the criteria for Low severity.

Plain-English summary

Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg) has been recalled nationwide within the United States. The product is packaged in cartons containing 3 wallets of 28 tablets each and is a prescription-only medication.

The recall was initiated on November 19, 2021, due to the drug being subpotent—meaning the tablets contain less active ingredient than the labeled amount. Lupin Pharmaceuticals initiated this recall voluntarily. The affected lot numbers are L000784 and L000785, with an expiration date of May 2022.

Approximately 4,113 cartons have been distributed nationwide. The product was distributed by Lupin Pharmaceuticals, Inc. in Baltimore, Maryland and manufactured by Lupin Limited in Pithampur, India. The recall was terminated on November 15, 2022.

The recalled product

Product
Tydemy (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,
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Oral Contraceptive
Hazard
  • subpotent-drug
  • under-potency

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: L000784 and L000785
  • Exp. Date May 2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category