Par Pharma Recalls Pramipexole ER Tablets Due to Impurities
Par Pharmaceutical recalls specific lots of Pramipexole Dihydrochloride Extended Release tablets due to failed impurity specifications. Check your bottle's lot number.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
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What happened, in plain English
Par Pharmaceutical is recalling certain bottles of Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, because they contain a known product impurity above approved specification levels. The recall affects 12,535 bottles distributed nationwide and in Puerto Rico. This issue relates to manufacturing quality control rather than an immediate physical hazard like choking or fire. Read more at govinfonow.com/recall/42599-par-pharma-recalls-pramipexole-er-tablets-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/42599-par-pharma-recalls-pramipexole-er-tablets-due-to-impurities · Updated October 9, 2026 · FDA enforcement record: FDA #D-1038-2016
Cite this page
“Par Pharma Recalls Pramipexole ER Tablets Due to Impurities.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42599-par-pharma-recalls-pramipexole-er-tablets-due-to-impurities. Based on FDA recall #D-1038-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1038-2016%22&limit=1).
Why it’s dangerous
The recalled tablets contain a known product impurity above currently approved specification levels. While the record does not specify the exact health effects of this impurity, taking medication that fails purity specifications may result in inconsistent dosing or exposure to unwanted substances, potentially affecting treatment efficacy or safety.
Who’s affected
Patients who have been prescribed Pramipexole Dihydrochloride Extended Release Tablets, specifically those with bottles from the affected lots manufactured by Par Pharmaceutical. Individuals who purchased these specific medications between the manufacturing dates and expiration dates listed below are at risk of receiving a product that does not meet quality standards.
How to tell if you have this one
Check your medication bottle for the following details: Product is Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles. Look for NDC 10370-251-11 and one of these Lot numbers: 27409201 (Exp. 02/2017), 27409301 (Exp. 02/2017), 27409401 (Exp. 02/2017), 27662101 (Exp. 07/2017). The manufacturer is Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY.
- Brand
Par Pharmaceutical- Category
Drug
What to do — step by step
Check Your Lot Number
Look at the label on your bottle of Pramipexole Dihydrochloride Extended Release Tablets to see if it matches one of the recalled lot numbers: 27409201, 27409301, 27409401, or 27662101.
Contact Your Pharmacist
If you have one of the recalled lots, contact your pharmacist or healthcare provider immediately to discuss how to replace the medication safely.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the NDC number for the recalled product?
The National Drug Code (NDC) for the affected bottles is 10370-251-11.
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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-1038-2016 (May 28, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1038-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.