Zydus Pharmaceuticals recalls 25mg clomipramine capsules due to nitrosamine impurities exceeding FDA limits. These capsules may pose health risks. Consumers should check product details and contact the manufacturer.
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Zydus Pharmaceuticals is recalling 25mg clomipramine hydrochloride capsules that contain nitrosamine impurities above the FDA's acceptable limit. This could pose health risks to users, especially those taking the medication regularly.
The capsules contain nitrosamine impurities (N-Nitroso Desmethyl-Clomipramine) that exceed the FDA's acceptable intake limit. This could potentially lead to health risks, though the exact impact is not specified in the recall notice.
People who have purchased or are using the recalled clomipramine capsules. Those with mental health conditions requiring this medication are at higher risk.
Check for 25mg clomipramine capsules with NDC numbers 16714-849-01 (30-count), 16714-849-02 (90-count), or 16714-849-03 (100-count). The capsules are prescription-only and manufactured by Zydus Lifesciences Ltd.
Identify the NDC number on the packaging to confirm if your capsules are part of the recall.
The recall states there is a risk of nitrosamine impurities exceeding FDA limits, but the exact health impact is not specified. Consult your healthcare provider for advice.
Look for NDC numbers 16714-849-01 (30-count), 16714-849-02 (90-count), or 16714-849-03 (100-count) on the packaging.
The recall does not specify a remedy, so contact Zydus Pharmaceuticals (USA) Inc for further instructions.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0152-2026 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0152-2026 from Zydus Pharmaceuticals. 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.
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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.
