Zydus Pharmaceuticals recalls 40mg esomeprazole suspension due to incorrect NDC number labeling. This affects prescription-only products sold in the US. No action is required as the product is safe but must be identified correctly.
Labeling: Not Elsewhere Classified - Wrong NDC number
Zydus Pharmaceuticals is recalling a specific prescription esomeprazole suspension product due to a labeling error with the NDC number. This means the product might be misidentified, but it does not pose a safety risk to users.
The product has a wrong NDC number on its label, which could lead to confusion about the product's identity. This might cause incorrect identification but does not affect the product's safety or effectiveness.
Prescription holders of the 40mg esomeprazole suspension (30 single-dose packets) manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India, distributed by Zydus Pharmaceuticals (USA) Inc. The risk is low as the product is safe but mislabeled.
Check for the NDC number 68382-849-94 on the label. The product is a 40mg esomeprazole suspension in 30 single-dose packets, sold by prescription in the US.
Look for the NDC number 68382-849-94 on the label to confirm it matches the recalled product.
No, the product is safe but has a wrong NDC number label, which could cause confusion about its identity.
No action is required as the product is safe; the issue is only a labeling error.
Check for the NDC number 68382-849-94 on the label. The product is a 40mg esomeprazole suspension in 30 single-dose packets.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0102-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0102-2025 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.
