Pramipexole Dihydrochloride Tablets — Class III drug recall D-1677-2012
Terminated recall by Sandoz Incorporated, reported 2012-09-26, distributed nationwide. Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred d
| Recall number | D-1677-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Incorporated, Broomfield, CO, United States |
| Recall initiated | 2012-09-12 |
| Classified | 2012-09-19 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2013-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 43,060 x |
| Reason classes | specification failure |
| Lot numbers | 12/12, 3340, BJ3338, BJ3339, BJ3341, BJ3342, BJ6282, BJ7192, BJ7202, BJ7203, BM8498 |
Product
Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,
Reason for recall
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability 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-1677-2012. 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.