Lupin Paroxetine Tablets Recall: Failed Dissolution Testing Risk
Lupin Pharmaceuticals recalls 12.5mg Paroxetine Extended-Release Tablets due to failed dissolution testing. Affected lots manufactured between Nov 2018 and March 2019. No specific remedy stated in recall notice.
Recall notice
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Contact the company
What happened, in plain English
Lupin Pharmaceuticals is recalling 12.5mg Paroxetine Extended-Release Tablets that failed dissolution testing. This means the medication may not release properly in the body, potentially affecting treatment effectiveness. The recall affects specific lots manufactured between November 2018 and March 2019. Read more at govinfonow.com/recall/41546-lupin-paroxetine-tablets-recall-failed-dissolution-testing-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41546-lupin-paroxetine-tablets-recall-failed-dissolution-testing-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0974-2017
Cite this page
“Lupin Paroxetine Tablets Recall: Failed Dissolution Testing Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41546-lupin-paroxetine-tablets-recall-failed-dissolution-testing-risk. Based on FDA recall #D-0974-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0974-2017%22&limit=1).
Why it’s dangerous
The medication failed dissolution testing, meaning it may not release properly in the body. This could lead to inconsistent drug levels and potentially affect treatment effectiveness. However, the recall does not specify serious injury risks.
Who’s affected
Prescription patients who received the recalled lots of Paroxetine Extended-Release Tablets. Those with mental health conditions requiring this medication are most at risk.
How to tell if you have this one
Check for the product name 'Paroxetine Extended-Release Tablets USP', 12.5 mg, 30 count bottle, prescription only. Look for lot numbers H605712, H605711, H605710 (expiring Nov 2018) or H702255, H702202 (expiring March 2019).
- Brand
Lupin Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the product name, dosage, and lot numbers listed in the recall notice to confirm if your medication is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 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.
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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-0974-2017 (June 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0974-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.