CLASS II Drug recall · Reported 24 Jul 2013 · FDA Enforcement Report
Estarylla (Norgestimate and Ethinyl Estradiol) Tablets recalled
Sandoz is recalling Estarylla (Norgestimate and Ethinyl Estradiol) Tablets, distributed in Indiana, Virginia. The recall was initiated on 21 Jun 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-805-2013
- FDA event ID
- 65511
- Recalling firm
- Sandoz, Broomfield, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2013
- FDA classified
- 17 Jul 2013
- Reported
- 24 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Hormones & Birth Control
Timeline
| 21 Jun 2013 | Recall initiated by company | |
| 17 Jul 2013 | Classified by FDA | +26 days |
| 24 Jul 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Product as listed by the FDA
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
Where it was distributed
Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
Questions about this recall
Why was it recalled?
Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
Which lots are affected?
Lot: LF01213A, Exp. 02/14
Where was it sold?
Distributed to one consignee in Indiana. No foreign, government, VA, or military consignees.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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