Sanofi recalls Zantac 75mg due to detected NDMA impurity. All lots affected. Consumers should stop using and contact Sanofi for details.
CGMP Deviations: Presence of NDMA impurity detected in product.
Sanofi is recalling all lots of Zantac 75mg tablets because they contain an impurity called NDMA. This impurity has been found in the product and may pose health risks. Consumers should stop using the medication and contact Sanofi for instructions.
The recall is due to the presence of NDMA, a chemical that has been linked to potential health risks when consumed in high amounts. While the exact risk level is not fully specified in the recall, the presence of this impurity is considered a safety concern.
All owners of Zantac 75mg tablets distributed by Sanofi. People taking this medication for heartburn or ulcers are most at risk.
Check for Zantac 75mg tablets with NDC code 68151-2584-0. All lots are affected, so no specific lot numbers are safe.
Immediately stop using Zantac 75mg tablets as they contain NDMA impurity.
Yes, all lots of Zantac 75mg tablets are affected by this recall.
The recall notice does not specify refund or replacement options.
NDMA is a chemical that has been linked to potential health risks when consumed in high amounts. The recall is due to its presence in the product.
We’ve drafted a message you can send Sanofi to request your refund or repair — edit it as you like.
Subject: Recall D-0543-2020 — Sanofi Sanofi Hello, I own a Sanofi that is covered by recall D-0543-2020 from Sanofi. 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.
