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.

Most common reason: Nitrosamine impurity (90 of these recalls)

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 300 mg

CGMP Deviations: Presence of NDMA impurity detected in product.

Terminated Nitrosamine impurity Direct Rx NDC 61919-455-30 D-0017-2021
Class II · Moderate risk

Ranitidine 150 mg

CGMP Deviations: Presence of NDMA impurity detected in product.

Terminated Nitrosamine impurity Direct Rx NDC 61919-339-60 D-0016-2021
Class II · Moderate risk

ranitidine hydrochloride

CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

Terminated Nitrosamine impurity PD-Rx Pharmaceuticals, Inc. NDC 43063-844-14 D-0826-2020
Class II · Moderate risk

Ranitidine

CGMP Deviations: Presence of NDMA impurity detected in product.

Terminated Nitrosamine impurity H J Harkins Company Inc dba Pharma Pac D-0793-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Presence of NDMA impurity detected in product.

Terminated Nitrosamine impurity Denton Pharma, Inc. NDC 70934-287-15 D-0795-2020
Class II · Moderate risk

Ranitidine Tablets

CGMP Deviations: Presence of NDMA impurity detected in product.

Terminated Nitrosamine impurity Denton Pharma, Inc. NDC 70934-017-04 D-0794-2020
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: Presence of NDMA impurity detected in product.

Terminated Nitrosamine impurity Preferred Pharmaceuticals, Inc NDC 68788-7078-03 D-0617-2020
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