CLASS III Drug recall · Reported 22 Jun 2016 · FDA Enforcement Report
Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg recalled
Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, distributed nationwide in the US. The recall was initiated on 28 May 2016 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-1038-2016
- FDA event ID
- 74270
- Recalling firm
- Par Pharmaceutical, Chestnut Ridge, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 May 2016
- FDA classified
- 16 Jun 2016
- Reported
- 22 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 28 May 2016 | Recall initiated by company | |
| 16 Jun 2016 | Classified by FDA | +19 days |
| 22 Jun 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
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
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
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #s: 27409201, 27409301, 27409401, Exp. 02/2017; 27662101, Exp. 07/2017
Where was it sold?
Nationwide and Puerto Rico.
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.
More recalls from Par Pharmaceutical
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | BusPIRone Hydrochloride Tablets, USP 7.5 mg recalled | Par Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate Tablets, USP 1 mg recalled by Par Pharmaceutical | Par Pharmaceutical | Potency & Assay | NY |
| Drug | CLASS III | PrediniSONE Tablets, USP 5 mg recalled by Par PharmaceuticalPrednisone | Par Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Frovatriptan Succinate Tablets, 2.5mg recalled by Par Pharmaceutical | Par Pharmaceutical | Labeling Errors | Nationwide |
| Drug | CLASS I | Mycophenolate Mofetil for Injection, USP 500 mg Dose Vials recalledMycophenolate Mofetil | Par Pharmaceutical | Particulate Matter | Nationwide |
Other Pramipexole Dihydrochloride recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pramipexole Dihydrochloride Tablets 0.125 mg recalledPramipexole Dihydrochloride | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.25 mg (10 recalled | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.5 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 1.0 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.125 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide |