Mirapex — Class III drug recall D-0991-2019
Terminated recall by Boehringer Ingelheim Pharmaceuticals, Inc., reported 2019-03-20, distributed nationwide. Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
| Recall number | D-0991-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States |
| Recall initiated | 2019-03-07 |
| Classified | 2019-03-11 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2019-09-11 |
| Distributed | Nationwide (US) |
| Quantity | 112 folding |
| Reason classes | specification failure |
| NDC | 00597-0190-61 |
| Lot numbers | AA3280A |
| Expiration dates | 2019-09-20 |
Product
Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.
Reason for recall
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine 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-0991-2019. 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.