clomiPRAMINE Hydrochloride Capsules USP 25 mg recall
FDA recall D-0537-2025 · initiated Jun 27, 2025
Lupin Pharmaceuticals Inc. recalled clomiPRAMINE Hydrochloride Capsules USP 25 mg in Jun 2025 — an FDA Class II recall (D-0537-2025) because Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,724 bottles
Details
- Product
- clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide.
- Initiated
- Jun 27, 2025
- FDA report date
- Jul 30, 2025
Frequently asked
- Was clomiPRAMINE Hydrochloride Capsules USP 25 mg recalled?
- Lupin Pharmaceuticals Inc. recalled clomiPRAMINE Hydrochloride Capsules USP 25 mg in Jun 2025 — an FDA Class II recall (D-0537-2025) because Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was clomiPRAMINE Hydrochloride Capsules USP 25 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0537-2025 was: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
- Is a recalled clomiPRAMINE Hydrochloride Capsules USP 25 mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of clomiPRAMINE Hydrochloride Capsules USP 25 mg are affected?
- Distributed: Nationwide.. The recall covers these lots — Lot # M300464, exp. date June, 2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0537-2025.