Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Ranitidine recalled?

Yes — there is an active recall. 18 ongoing FDA recalls mention Ranitidine (100 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Ranitidine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Ranitidine recalls on record

none so far in 2026; 100 on record, newest first
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 Tablets

CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Terminated Nitrosamine impurity American Health Packaging D-1003-2020
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

Ranitidine Syrup

CGMP Deviations: Presence of NDMA impurity detected in product.

Terminated Nitrosamine impurity American Health Packaging NDC 60687-260-69 D-0631-2020