FDA Drug recall D-805-2013
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets
- FDA Drug
- Class II
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class II recall of Estarylla (Norgestimate and Ethinyl Estradiol) Tablets by Sandoz, citing contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-805-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-21 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | IN, VA |
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
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Identifiers
| code_info | Lot: LF01213A, Exp. 02/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-805-2013%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.