Estarylla — Class II drug recall D-805-2013
Terminated recall by Sandoz Incorporated, reported 2013-07-24, distributed in IN. Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
| Recall number | D-805-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Incorporated, Broomfield, CO, United States |
| Recall initiated | 2013-06-21 |
| Classified | 2013-07-17 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2014-01-29 |
| Distributed | IN |
| Quantity | 10,848 cartons |
| NDC | 00781-4058-15 |
| Lot numbers | 02/14, LF01213A |
Product
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
Reason for recall
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
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-805-2013. 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.