CLASS III Drug recall · Reported 20 Mar 2019 · FDA Enforcement Report
Mirapex (pramipexole dihydrochloride) Tablets recalled
Boehringer Ingelheim Pharmaceuticals is recalling Mirapex (pramipexole dihydrochloride) Tablets, 1 mg unit-dose tablets per folding, distributed nationwide in the US. The recall was initiated on 7 Mar 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0991-2019
- FDA event ID
- 82310
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Mar 2019
- FDA classified
- 11 Mar 2019
- Reported
- 20 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 7 Mar 2019 | Recall initiated by company | |
| 11 Mar 2019 | Classified by FDA | +4 days |
| 20 Mar 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Which lots are affected?
Lot # AA3280A, Exp SEP 2019
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.