Pramipexole dihydrochloride extended release tablets — Class III drug recall D-1185-2018
Terminated recall by Par Pharmaceutical, Inc., reported 2018-09-19, distributed nationwide. Failed impurities/degradation specifications: Finished product contain a known product impurity about current
| Recall number | D-1185-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Par Pharmaceutical, Inc., Chestnut Ridge, NY, United States |
| Recall initiated | 2018-09-06 |
| Classified | 2018-09-10 |
| Reported by FDA | 2018-09-19 |
| Terminated | 2019-12-06 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 10370-0252-11 |
| Lot numbers | 12/18, 2/19, 29906202, 29993102, 3/20, 30366102, 30373103, 31940601, 4/19 |
Product
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
Reason for recall
Failed impurities/degradation specifications: Finished product contain a known product impurity about current 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-1185-2018. 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.