Zydus Pharmaceuticals recalls 75mg clomipramine capsules due to nitrosamine impurities exceeding FDA limits. Affected lots have specific NDC numbers and expiration dates.
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 75mg clomipramine hydrochloride capsules because they contain nitrosamine impurities above the FDA's safe limit. This could pose a health risk if taken regularly.
The capsules contain nitrosamine impurities (N-Nitroso Desmethyl-Clomipramine) that exceed the FDA's acceptable intake limit. This could potentially cause health issues if taken over time, though the risk is not immediately life-threatening.
People who have the recalled clomipramine capsules (75mg) with specific NDC numbers and expiration dates. Those taking the medication for depression or anxiety may be at risk if the impurities exceed safe levels.
Check for NDC numbers: 16714-851-01 (30-count), 16714-851-02 (90-count), or 16714-851-03 (100-count). Also look for specific lot numbers and expiration dates listed in the recall notice.
Look for the NDC numbers and expiration dates listed in the recall notice to confirm if your capsules are affected.
The recall states that the capsules contain nitrosamine impurities above the FDA's acceptable limit, so they are not safe to take as recalled.
The recall does not specify a remedy, so you should check with your healthcare provider for guidance on safe alternatives.
Check the NDC numbers and expiration dates on your capsules against the list provided in the recall notice.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0154-2026 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0154-2026 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.
