CLASS III Drug recall · Reported 5 Oct 2022 · FDA Enforcement Report
ClomiPRAMINE Hydrochloride Capsules, USP 25mg recalled by Leading Pharma
Leading Pharma is recalling ClomiPRAMINE Hydrochloride Capsules, USP 25mg, distributed nationwide in the US. The recall was initiated on 23 Aug 2022 and the FDA has classified it as Class III.
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-1546-2022
- FDA event ID
- 90853
- Recalling firm
- Leading Pharma, Fairfield, NJ
- Manufacturer
- Leading Pharma, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Aug 2022
- FDA classified
- 28 Sep 2022
- Reported
- 5 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 23 Aug 2022 | Recall initiated by company | |
| 28 Sep 2022 | Classified by FDA | +36 days |
| 5 Oct 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
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 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Which lots are affected?
Lot#: B14221, Exp. Date 02/2023
Where was it sold?
Nationwide within the United States
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Leading Pharma
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Furosemide Tablets, USP, 80 mg recalled by Leading PharmaFurosemide | Leading Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Lorazepam Tablets, USP CIV, 0.5 mg recalled by Leading PharmaLorazepam | Leading Pharma | Other | Nationwide |
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 II | clomiPRAMINE hydrochloride Capsules USP, 25 mg recalledClomipramine Hydrochloride | Lupin Pharmaceuticals | Potency & Assay | Nationwide |