Amneal recalls Ranitidine Syrup Oral Solution 15 mg/mL 6 fl oz due to N-nitrosodimethylamine (NDMA) impurity found in the active pharmaceutical ingredient.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Amneal is recalling a specific ranitidine syrup product because it contains an impurity called NDMA, which has been linked to potential health risks. This recall affects people who have this particular syrup bottle with the NDC number 65162-664-90.
The product contains N-nitrosodimethylamine (NDMA), an impurity that has been found in the active pharmaceutical ingredient. This impurity has been linked to potential health risks, including liver damage, though the exact risk level is not fully established.
People who have the recalled ranitidine syrup product (NDC 65162-664-90) are affected. Children and adults who use this medication for heartburn or ulcers are at risk if they have the product.
Check for the product label that says 'Ranitidine Syrup Oral Solution 15 mg/mL 6 fl oz (473 mL)' with NDC number 65162-664-90. The product was sold from November 2019 to January 2021.
Look for the NDC number 65162-664-90 on the bottle label.
The recall states that the product contains an impurity (NDMA) that has been linked to potential health risks, but the exact risk level is not fully established.
Check for the product label that says 'Ranitidine Syrup Oral Solution 15 mg/mL 6 fl oz (473 mL)' with NDC number 65162-664-90. The product was sold from November 2019 to January 2021.
The recall does not specify a remedy, so you should check with your healthcare provider or contact Amneal Pharmaceuticals for guidance.
We’ve drafted a message you can send Amneal to request your refund or repair — edit it as you like.
Subject: Recall D-0614-2020 — Amneal Amneal Hello, I own a Amneal that is covered by recall D-0614-2020 from Amneal. 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.
