Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

60 recalls, newest first

Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Ongoing Nitrosamine impurity Granules India Limited NDC 62207-773-32 D-0632-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Ongoing Nitrosamine impurity Amneal Pharmaceuticals, Inc. NDC 53746-254-02 D-0616-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Ongoing Nitrosamine impurity Amneal Pharmaceuticals, Inc. NDC 53746-253-10 D-0615-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Ongoing Nitrosamine impurity Amneal Pharmaceuticals, Inc. NDC 65162-254-30 D-0613-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Ongoing Nitrosamine impurity Amneal Pharmaceuticals, Inc. NDC 65162-253-06 D-0612-2020
Class II · Moderate risk

Ranitidine Syrup

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Ongoing Nitrosamine impurity AuroMedics Pharma LLC NDC 65862-431-74 D-0529-2020
Class II · Moderate risk

Zantac 75 mg

CGMP Deviations: Presence of NDMA impurity detected in product.

Ongoing Nitrosamine impurity Sanofi-Aventis U.S. LLC D-0545-2020
Class II · Moderate risk

Zantac 150 mg

CGMP Deviations: Presence of NDMA impurity detected in product.

Ongoing Nitrosamine impurity Sanofi-Aventis U.S. LLC D-0544-2020

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