Lupin Imipramine Capsules 125mg Recall: Dissolution Test Issue
Lupin Pharmaceuticals recalls 125mg Imipramine Pamoate Capsules due to dissolution test failure at 9 months. This may affect drug stability. Check NDC# 68180-316-06 and lot H002205.
Lower-risk recall
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Contact the company
What happened, in plain English
Lupin Pharmaceuticals is recalling 125mg Imipramine Pamoate Capsules (30-count) because a dissolution test showed instability after 9 months. This could mean the medication doesn't work properly over time, but the recall doesn't specify immediate safety risks. Read more at govinfonow.com/recall/35798-lupin-imipramine-capsules-125mg-recall-dissolution-test-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/35798-lupin-imipramine-capsules-125mg-recall-dissolution-test-issue · Updated August 18, 2026 · FDA enforcement record: FDA #D-0027-2022
Cite this page
“Lupin Imipramine Capsules 125mg Recall: Dissolution Test Issue.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35798-lupin-imipramine-capsules-125mg-recall-dissolution-test-issue. Based on FDA recall #D-0027-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0027-2022%22&limit=1).
Why it’s dangerous
The dissolution test showed the medication didn't dissolve properly after 9 months of storage. This could mean the drug becomes less effective over time, but the recall doesn't indicate immediate safety hazards like injury or death.
Who’s affected
Prescription patients who have the 125mg Imipramine Pamoate Capsules 30-count bottle with NDC# 68180-316-06 and lot H002205. Those with the medication are most at risk if they need long-term treatment.
How to tell if you have this one
Check for the NDC code 68180-316-06 and lot number H002205 on the bottle. The product is a prescription-only 125mg Imipramine Pamoate Capsules 30-count bottle manufactured in Baltimore, Maryland.
- Brand
Lupin Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for NDC# 68180-316-06 and lot H002205 on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed 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 17 months 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.
Questions people ask
Is this product dangerous?
The recall is due to potential reduced effectiveness after 9 months, not immediate safety risks. The product is not considered dangerous in normal use.
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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-0027-2022 (October 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0027-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.