Zydus Pharmaceuticals recalls 50mg clomipramine capsules due to nitrosamine impurities exceeding FDA limits. This may pose health risks. Check NDC numbers and lot dates for affected products.
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 50mg clomipramine hydrochloride capsules because they contain nitrosamine impurities above the FDA's safe limit. This could pose health risks to users, especially those taking the medication regularly.
The capsules contain nitrosamine impurities, specifically N-Nitroso Desmethyl-Clomipramine, which exceed the FDA's acceptable intake limit. This could potentially lead to health risks, though the exact impact isn't specified in the recall notice.
People who have the recalled clomipramine capsules (50mg, USP) from Zydus Pharmaceuticals, typically prescribed for depression or anxiety. Those with higher medication intake or sensitive health conditions may be at greater risk.
Check for 50mg clomipramine hydrochloride capsules with NDC numbers 16714-850-01 (30-count), 16714-850-02 (90-count), or 16714-850-03 (100-count). Also look for specific lot numbers and expiration dates listed in the recall notice.
Identify the NDC number and lot number on your capsule packaging to determine if it's part of the recall.
The recall states the product contains nitrosamine impurities above FDA limits, but does not specify if it's safe to use. The official notice does not provide details on safe usage.
Check the NDC numbers 16714-850-01, 16714-850-02, or 16714-850-03 and the specific lot numbers listed in the recall notice.
The recall notice does not specify a remedy or action for affected products. You should contact Zydus Pharmaceuticals for further guidance.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0153-2026 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0153-2026 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.
