Sanofi recalls Zantac 75mg tablets with NDMA impurity detected. Affected lots include NDCs 0597-0122-01 to 0597-0122-96. Consumers should contact Sanofi for details.
CGMP Deviations: Presence of NDMA impurity detected in product.
Sanofi is recalling Zantac 75mg tablets due to a detected NDMA impurity. This chemical has been linked to potential health risks, so affected consumers should stop using the medication and contact Sanofi for guidance.
The recall is for a chemical called NDMA that was found in the medication. While the exact health risks are not fully specified, NDMA has been associated with potential health concerns in some cases. The presence of this impurity is a regulatory issue that requires action.
People who have Zantac 75mg tablets with the listed NDC numbers (0597-0122-01 to 0597-0122-96) are affected. Those taking this medication for conditions like heartburn or ulcers are most at risk.
Check the NDC numbers on the packaging: 0597-0122-01 through 0597-0122-96. The product was distributed by Sanofi through Chattem, Inc. in Chattanooga, Tennessee.
Look for the NDC numbers 0597-0122-01 to 0597-0122-96 on the packaging.
The recall record mentions NDMA as a chemical detected in the product, but does not provide details about what it is.
Check the NDC numbers on the packaging: 0597-0122-01 through 0597-0122-96.
The recall record does not specify a remedy, so consumers should contact Sanofi directly for guidance.
We’ve drafted a message you can send Sanofi to request your refund or repair — edit it as you like.
Subject: Recall D-0545-2020 — Sanofi Sanofi Hello, I own a Sanofi that is covered by recall D-0545-2020 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.
