Leading Pharma ClomiPRAMINE Hydrochloride Capsules Recall

Why it was recalled

Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

Product description

ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01

Lot numbers, UPCs & expiration codes

Lot#: B14221, Exp. Date 02/2023

Where it was sold

Nationwide within the United States

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1546-2022
Classification: Class III
Status: Terminated
Recall initiated: Aug 23, 2022
FDA report date: Oct 5, 2022
Quantity: 960 bottles (100 capsules)
Recall type: Voluntary: Firm initiated
Recalling firm: Leading Pharma, LLC

Original FDA data

Every field from FDA enforcement report D-1546-2022, exactly as published.

Show all FDA fields

City: Fairfield
State: NJ
Status: Terminated
Country: United States
Event ID: 90853
Address: 3 Oak Rd
Code information: Lot#: B14221, Exp. Date 02/2023
Postal code: 07004-2903
Report date: Oct 5, 2022
Product type: Drugs
Recall number: D-1546-2022
Classification: Class III
Recalling firm: Leading Pharma, LLC
Product quantity: 960 bottles (100 capsules)
Termination date: Sep 28, 2023
Reason for recall: Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Voluntary / mandated: Voluntary: Firm initiated
Product description: ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
Distribution pattern: Nationwide within the United States
Recall initiation date: Aug 23, 2022
Initial firm notification: Letter
Center classification date: Sep 28, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1546-2022, published Oct 5, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.