Copaxone — Class II drug recall D-1442-2012
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2012-08-15, distributed nationwide. Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified
| Recall number | D-1442-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., Sellersville, PA, United States |
| Recall initiated | 2012-05-18 |
| Classified | 2012-08-03 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2013-04-11 |
| Distributed | Nationwide (US) |
| Quantity | 6,647 cartons |
| NDC | 68546-0317, 68546-0317-00, 68546-0317-30, 68546-0325, 68546-0325-06, 68546-0325-12 |
| Lot numbers | 08/13, X05011 |
Product
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30
Reason for recall
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
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-1442-2012. 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.