Jolessa — Class III drug recall D-1384-2012
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2012-06-27, distributed nationwide. Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen p
| Recall number | D-1384-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., Sellersville, PA, United States |
| Recall initiated | 2012-04-23 |
| Classified | 2012-06-19 |
| Reported by FDA | 2012-06-27 |
| Terminated | 2013-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 40,750 dispensers |
| NDC | 00555-9123-66 |
| Lot numbers | 33801826A, 33802144A, 33802323A, 33802519A |
| Expiration dates | 2013-01, 2013-03, 2013-06 |
Product
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.
Reason for recall
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo 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-1384-2012. 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.