Macleods Pharma Recalls Pramipexole Tablets Due to Foreign Drug Presence
Macleods Pharma USA recalls specific lots of Pramipexole Dihydrochloride 0.125 mg tablets due to the presence of a comingled Carbimazole tablet.
Use caution until it’s fixed
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Contact the company
What happened, in plain English
Macleods Pharma USA, Inc. is recalling bottles of Pramipexole Dihydrochloride Tablets 0.125 mg because they may contain an unwanted foreign tablet. Specifically, the recall addresses the presence of a comingled Carbimazole 5 mg tablet within the bottles. This issue affects products distributed nationwide in the United States. Read more at govinfonow.com/recall/43306-macleods-pharma-recalls-pramipexole-tablets-due-to-foreign-drug-presence.
Source Summary by GovInfoNow · govinfonow.com/recall/43306-macleods-pharma-recalls-pramipexole-tablets-due-to-foreign-drug-presence · Updated October 11, 2026 · FDA enforcement record: FDA #D-0653-2016
Cite this page
“Macleods Pharma Recalls Pramipexole Tablets Due to Foreign Drug Presence.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43306-macleods-pharma-recalls-pramipexole-tablets-due-to-foreign-drug-presence. Based on FDA recall #D-0653-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0653-2016%22&limit=1).
Why it’s dangerous
The presence of a Carbimazole tablet poses a risk because it is a different drug than prescribed, potentially leading to incorrect treatment or adverse reactions. Ingesting an unlisted foreign substance can interfere with the intended therapeutic effect of the Pramipexole.
Who’s affected
Patients prescribed Pramipexole Dihydrochloride for conditions such as Parkinson's disease or Restless Legs Syndrome who purchased the affected bottles are at risk of ingesting an unintended medication. The specific lot involved was distributed nationwide.
How to tell if you have this one
Check your bottle for the NDC number 33342-031-10 and Lot number BPA512A. The product is labeled as 'Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only' and was manufactured for Macleods Pharma USA, Inc. in Plainsboro, NJ.
- Brand
Macleods Pharma USA- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0653-2016 (December 24, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0653-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.