Data Foundry

Drug recalls 2021

Tydemy — Class III drug recall D-0264-2022

Terminated recall by Lupin Pharmaceuticals Inc., reported 2021-12-08, distributed nationwide. Subpotent Drug

Recall numberD-0264-2022
Product typeDrug
ClassificationClass III
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmLupin Pharmaceuticals Inc., Baltimore, MD, United States
Recall initiated2021-11-19
Classified2021-12-01
Reported by FDA2021-12-08
Terminated2022-11-15
DistributedNationwide (US)
Quantity4,113 cartons
Reason classespotency
NDC68180-0904-11, 68180-0904-13
Lot numbersL000784, L000785
Expiration dates2022-05-20

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, 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.

Reason for recall

Subpotent Drug

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0264-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.