Macleods Pharma Usa Inc recalls Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc.
Macleods Pharma recalls 0.125mg pramipexole tablets due to stability study showing subpotent drug. Patients should contact their doctor for alternative treatment options.
Lower-risk recall
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Contact the company & request your remedy
What happened, in plain English
Macleods Pharma is recalling 0.125mg pramipexole tablets that may not contain the correct drug strength. This could lead to ineffective treatment for patients using these medications. Read more at govinfonow.com/recall/38083-macleods-pramipexole-tablets-0-125mg-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38083-macleods-pramipexole-tablets-0-125mg-recall-subpotent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1851-2019
Cite this page
“Macleods Pramipexole Tablets 0.125mg Recall: Subpotent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38083-macleods-pramipexole-tablets-0-125mg-recall-subpotent-drug-risk. Based on FDA recall #D-1851-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1851-2019%22&limit=1).
Why it’s dangerous
The stability study showed the tablets may not contain the full drug strength. This could result in the medication being less effective than intended, but does not cause immediate harm.
Who’s affected
Patients prescribed pramipexole tablets by a doctor are affected. Those with the specific NDC 33342-031-10 lot #BPA801A are at risk.
How to tell if you have this one
Check for the NDC code 33342-031-10 and lot number BPA801A on the product label. These tablets were manufactured in Plainsboro, NJ and sold with an expiration date of 12/2020.
- Brand
Macleods- Category
Drug
What to do — step by step
Contact Your Doctor
Talk to your healthcare provider about alternative treatment options since the medication may not be effective.
Questions people ask
Is this medication dangerous?
No, the recall is for potential reduced effectiveness, not immediate safety risks.
How can I tell if I have the recalled product?
Check for NDC 33342-031-10 and lot number BPA801A on the label.
What should I do if I have the recalled product?
Contact your doctor for alternative treatment options as the medication may not be effective.
Contact Macleods
We’ve drafted a message you can send Macleods to request your refund or repair — edit it as you like.
Subject: Recall D-1851-2019 — Macleods Macleods Hello, I own a Macleods that is covered by recall D-1851-2019 from Macleods. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1851-2019 (August 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1851-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.