FDA Drug recall D-1081-2023
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg),…
- FDA Drug
- Class I
- terminated
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class I recall of Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg),… by Lupin Pharmaceuticals, citing failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1081-2023 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2023-06-23 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Identifiers
| ndc | 68180-904-73 |
|---|---|
| ndc | 68180-905-74 |
| ndc | 68180-910-74 |
| ndc | 68180-904-71 |
| code_info | Lot #: L200183, Exp 1/2024; L201560, Exp 9/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1081-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.