Pramipexole Dihydrochloride Extended Release Tablets — Class III drug recall D-1038-2016
Terminated recall by Par Pharmaceutical, reported 2016-06-22, distributed nationwide. Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Exte
| Recall number | D-1038-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Par Pharmaceutical, Chestnut Ridge, NY, United States |
| Recall initiated | 2016-05-28 |
| Classified | 2016-06-16 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-03-03 |
| Distributed | Nationwide (US) |
| Quantity | 12,535 bottles |
| Reason classes | specification failure |
| NDC | 10370-0251-11 |
| Lot numbers | 27409201, 27409301, 27409401, 27662101 |
| Expiration dates | 2017-02, 2017-07 |
Product
Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11
Reason for recall
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
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-1038-2016. 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.