Pramipexole Dihydrochoride Tablets 0 — Class II drug recall D-1444-2019
Terminated recall by Zydus Pharmaceuticals USA Inc, reported 2019-06-26, distributed nationwide. CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
| Recall number | D-1444-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals USA Inc, Pennington, NJ, United States |
| Recall initiated | 2019-05-06 |
| Classified | 2019-07-01 |
| Reported by FDA | 2019-06-26 |
| Terminated | 2021-09-16 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 68382-0197-16 |
| Lot numbers | DEC-19, JAN-21, JUL-20, M706802, M706804, M706907, M706909, M707028, M714180, M714181, M714923, M714924, M714925, M717063, M717064, M801705, M801706, M801707, M801708, M808307, M808308, M808309, M808310, M812479, M812481, M812482, M812483, M815787, M815788, M815789, M815790, M815791, M820265, M820266, M820267, M820268, M820269, M903040, M903041, M903042 and 5 more |
Product
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
Reason for recall
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
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-1444-2019. 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.