clomiPRAMINE hydrochloride Capsules USP recall
FDA recall D-0377-2025 · initiated Apr 10, 2025
Lupin Pharmaceuticals Inc. recalled clomiPRAMINE hydrochloride Capsules USP in Apr 2025 — an FDA Class II recall (D-0377-2025) because Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
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 18-month long term stability study.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 2724 bottles
Details
- Product
- clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide
- Initiated
- Apr 10, 2025
- FDA report date
- Apr 30, 2025
Frequently asked
- Was clomiPRAMINE hydrochloride Capsules USP recalled?
- Lupin Pharmaceuticals Inc. recalled clomiPRAMINE hydrochloride Capsules USP in Apr 2025 — an FDA Class II recall (D-0377-2025) because Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was clomiPRAMINE hydrochloride Capsules USP recalled?
- Per the FDA enforcement record, the reason for recall D-0377-2025 was: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
- Is a recalled clomiPRAMINE hydrochloride Capsules USP 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 are affected?
- Distributed: USA nationwide. The recall covers these lots — Lot #: M300442, Exp Date: 6/30/2025. 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-0377-2025.