Jolessa — Class III drug recall D-683-2013
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2013-07-17, distributed nationwide. Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was de
| Recall number | D-683-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., Sellersville, PA, United States |
| Recall initiated | 2013-03-15 |
| Classified | 2013-07-05 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2014-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 54,412 blister |
| Reason classes | chemical contamination, specification failure |
| NDC | 00555-9123-66 |
| Lot numbers | 33802986A, 33802991A, 33803270A |
| Expiration dates | 2013-07, 2013-09, 2013-10 |
Product
Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66
Reason for recall
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
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-683-2013. 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.