Zeosa — Class II drug recall D-1397-2012
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2012-07-04, distributed nationwide. Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impuri
| Recall number | D-1397-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., Sellersville, PA, United States |
| Recall initiated | 2012-05-02 |
| Classified | 2012-06-26 |
| Reported by FDA | 2012-07-04 |
| Terminated | 2013-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 100,761 cartons |
| Reason classes | specification failure |
| NDC | 00093-2090-28, 00093-2090-58 |
| Lot numbers | 33800226A, 33800333A, 33800870A, 33802533A, 33802720A |
| Expiration dates | 2012-07, 2012-10, 2013-04, 2013-08 |
Product
Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs
Reason for recall
Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
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-1397-2012. 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.