Class II · Moderate risk
Nizatidine Oral Solution
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Is Nizatidine recalled?
Not under an active recall.
Nizatidine was recalled 3 times in the past — all now closed. Most recent: Apr 15, 2020.
Most common reason: Nitrosamine impurity (3 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Nizatidine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Nizatidine recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
Nizatidine Capsules
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class II · Moderate risk
Nizatidine Capsules
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
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