CLASS II Drug recall · Reported 26 Jun 2019 · FDA Enforcement Report
Pramipexole Dihydrochloride Tablets 25 mg recalled
Zydus Pharmaceuticals USA is recalling Pramipexole Dihydrochloride Tablets 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-1445-2019
- 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 Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Pramipexole Dihydrochloride Tablets 25 mg recalled?
Yes. Zydus Pharmaceuticals USA recalled Pramipexole Dihydrochloride Tablets 25 mg on 6 May 2019. The recall is Class II and its status is Terminated. Recall number D-1445-2019.
Why was it recalled?
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Which lots are affected?
Lots: M706803, EXP Jun-19; M713438, EXP Oct-19; M801704, EXP Jan-20; M808306, EXP Jun-20; M812484, EXP Aug-20; M820264, EXP Dec-20
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 21 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 Zydus Pharmaceuticals USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals (USA) | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals (USA) | Potency & Assay | Nationwide |
Other Pramipexole di recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pramipexole Dihydrochloride Tablets 125 mg recalledPramipexole Dihydrochloride | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 25 mg (10 x recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 5 mg per blister card) recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0 mg per blister card) recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 125 mg per blister card) recalled | American Health Packaging | Packaging Defects | Nationwide |