Jolessa — Class III drug recall D-246-2013
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2013-04-17, distributed nationwide. Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result f
| Recall number | D-246-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., Sellersville, PA, United States |
| Recall initiated | 2013-03-12 |
| Classified | 2013-04-10 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2014-01-15 |
| Distributed | Nationwide (US) |
| Quantity | 71,893 dispensers |
| Reason classes | specification failure |
| NDC | 00555-9123-66 |
| Lot numbers | 03/14, 11/13, 33803603A, 33803604A, 33803996A, 33803997A |
Product
Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.
Reason for recall
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
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-246-2013. 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.