Tydemy — Class I drug recall D-1081-2023
Terminated recall by Lupin Pharmaceuticals Inc., reported 2023-08-09, distributed nationwide. Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inac
| Recall number | D-1081-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2023-06-23 |
| Classified | 2023-08-04 |
| Reported by FDA | 2023-08-09 |
| Terminated | 2025-01-28 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 68180-0904, 68180-0904-71, 68180-0904-73, 68180-0905-74, 68180-0910-74 |
| Lot numbers | L200183, L201560 |
| Expiration dates | 2024-01, 2024-09 |
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
Reason for recall
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
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-1081-2023. 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.