FDA Drug recall D-854-2013
Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons…
- FDA Drug
- Class III
- terminated
- Published 2013-08-14
On 2013-08-14 the FDA classified a Class III recall of Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons… by Sandoz, citing contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recal….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-854-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-08-07 |
| Published | 2013-08-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | US |
Product
Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36
Reason
Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due to inactive placebo tablets incorrectly placed in Week 9, and active tablets placed in Week 13 on the blister card
Identifiers
| code_info | Lots: LF01643C, LF01644C, Exp 7/14 |
|---|
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-854-2013%22
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