Leading Pharma recalls 25mg Clomipramine hydrochloride capsules (NDC 69315-167-01) due to higher-than-stated drug content. This may cause overdose risk if taken as prescribed.
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
Leading Pharma is recalling 25mg Clomipramine hydrochloride capsules because they contain 110.6% of the labeled drug amount. This could lead to overdose if taken as directed, especially since these are prescription-only medications.
The capsules contain 110.6% of the labeled drug amount, meaning each capsule has more active ingredient than specified. This could lead to an overdose if taken as directed, though the risk is low since these are prescription-only medications.
Prescription patients who have the specific 25mg capsules with NDC 69315-167-01. Those most at risk are individuals who might take more than intended due to the higher drug content.
Check for the product name 'Clomipramine Hydrochloride Capsules, USP 25mg', 100-count bottles, manufactured by Leading Pharma, LLC, with NDC 69315-167-01 and lot number B14221.
Verify the product label includes NDC 69315-167-01 and lot number B14221.
The product contains higher-than-stated drug content, which could lead to overdose if taken as directed. However, it is prescription-only and the risk is considered low.
The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to stop using it.
Look for the product name 'Clomipramine Hydrochloride Capsules, USP 25mg', 100-count bottles, manufactured by Leading Pharma, LLC, with NDC 69315-167-01 and lot number B14221.
We’ve drafted a message you can send Leading Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-1546-2022 — Leading Pharma Leading Pharma Hello, I own a Leading Pharma that is covered by recall D-1546-2022 from Leading Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
