Junel — Class III drug recall D-682-2013
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-682-2013 |
|---|---|
| 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 | 47,200 blister |
| Reason classes | chemical contamination, specification failure |
| NDC | 00555-9025, 00555-9025-42, 00555-9026, 00555-9026-58, 00555-9027, 00555-9027-42, 00555-9028, 00555-9028-58 |
| Lot numbers | 33802123A, 33802202A, 33802203A, 33802204A |
| Expiration dates | 2013-04, 2013-05 |
Product
Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58
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-682-2013. 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.