CLASS II Drug recall · Reported 26 Jun 2019 · FDA Enforcement Report
Pramipexole Dihydrochoride Tablets 0.25 mg recalled
Zydus Pharmaceuticals USA is recalling Pramipexole Dihydrochoride Tablets 0.25 mg, distributed nationwide in the US. The recall was initiated on 6 May 2019 and the FDA has classified it as Class II.
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-1444-2019
- FDA event ID
- 82827
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 May 2019
- FDA classified
- 1 Jul 2019
- Reported
- 26 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 6 May 2019 | Recall initiated by company | |
| 26 Jun 2019 | Published in enforcement report | +51 days |
| 1 Jul 2019 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Product as listed by the FDA
Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Which lots are affected?
Lots: M706802, M706804, M706907, M706909, M707028, EXP May-19; M714180, M714181, EXP Oct-19; M717063, M717064, M801705, M801706, M801707, M801708, M714923, M714924, M714925 EXP Dec-19; M808307, M808308, M808309, M808310, EXP May-20; M812479, M812481, M812482, M812483, EXP Jul-20; M815787 M815789, M815790, M815791, M815788, EXP Sep-20; M820266, M820267, M820268, M820269, M820265 EXP Nov-20; M903040, M903041, M903042 EXP Jan-21.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
13 other products · FDA event 82827This product is part of a recall event; the main page for the event is MethylPREDNISolone Tablets, USP, 4 mg recalled.
More recalls from Zydus Pharmaceuticals USA
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 1 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Tablets, USP 32 mg recalledMethylprednisolone | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.25 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.125 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |