CLASS II Drug recall · Reported 30 Jul 2025 · FDA Enforcement Report
clomiPRAMINE Hydrochloride Capsules USP 25 mg recalled
Lupin Pharmaceuticals is recalling clomiPRAMINE Hydrochloride Capsules USP 25 mg, 5801 Pelican Bay Boulevard, Suite 500, distributed nationwide in the US. The recall was initiated on 27 Jun 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0537-2025
- FDA event ID
- 97159
- Recalling firm
- Lupin Pharmaceuticals, Naples, FL
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2025
- FDA classified
- 21 Jul 2025
- Reported
- 30 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 27 Jun 2025 | Recall initiated by company | |
| 21 Jul 2025 | Classified by FDA | +24 days |
| 30 Jul 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Where it was distributed
Nationwide.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot # M300464, exp. date June, 2025
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Clomipramine recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg recalledClomipramine Hydrochloride | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg recalledClomipramine Hydrochloride | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg recalledClomipramine Hydrochloride | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | clomiPRAMINE hydrochloride Capsules USP, 25 mg recalledClomipramine Hydrochloride | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | ClomiPRAMINE Hydrochloride Capsules, USP 25mg recalled by Leading PharmaClomipramine Hydrochloride | Leading Pharma | Potency & Assay | Nationwide |