Pramipexole Dihydrochloride Tablets 0 — Class II drug recall D-0653-2016
Terminated recall by Macleods Pharma Usa Inc, reported 2016-02-17, distributed nationwide. Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
| Recall number | D-0653-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharma Usa Inc, Plainsboro, NJ, United States |
| Recall initiated | 2015-12-24 |
| Classified | 2016-02-05 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2020-08-31 |
| Distributed | Nationwide (US) |
| NDC | 33342-0031, 33342-0031-06, 33342-0031-10, 33342-0031-12, 33342-0031-15, 33342-0032, 33342-0032-06, 33342-0032-10, 33342-0032-12, 33342-0032-15, 33342-0033, 33342-0033-06, 33342-0033-10, 33342-0033-12, 33342-0033-15, 33342-0034, 33342-0034-06, 33342-0034-10, 33342-0034-12, 33342-0034-15, 33342-0035, 33342-0035-06, 33342-0035-10, 33342-0035-12, 33342-0035-15 |
| Lot numbers | BPA512A |
| Expiration dates | 2017-06 |
Product
Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.
Reason for recall
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
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-0653-2016. 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.