Pramipexole Dihydrochloride Tablets 0 — Class III drug recall D-1851-2019
Terminated recall by Macleods Pharma Usa Inc, reported 2019-09-18, distributed nationwide. Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.12
| Recall number | D-1851-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharma Usa Inc, Plainsboro, NJ, United States |
| Recall initiated | 2019-08-21 |
| Classified | 2019-09-11 |
| Reported by FDA | 2019-09-18 |
| Terminated | 2021-01-28 |
| Distributed | Nationwide (US) |
| Reason classes | potency, specification failure |
| 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 | BPA801A |
| Expiration dates | 2020-12 |
Product
Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10
Reason for recall
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
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-1851-2019. 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.