Drospirenone and Ethinyl Estradiol Tablets — Class I drug recall D-1837-2019
Terminated recall by Jubilant Cadista Pharmaceuticals, Inc., reported 2019-08-07, distributed nationwide. Failed dissolution specifications : failed results at the 3-month stability time point.
| Recall number | D-1837-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, United States |
| Recall initiated | 2019-07-09 |
| Classified | 2019-08-19 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2021-05-07 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 59746-0763-43 |
| Lot numbers | 183222 |
| Expiration dates | 2020-11 |
Product
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43
Reason for recall
Failed dissolution specifications : failed results at the 3-month stability time point.
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-1837-2019. 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.