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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Oral Contraceptive
- Affected units
- 4,113
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.
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