Histamine-2 receptor antagonists recalled due to detection of probable carcinogen

Batches of ranitidine and nizatidine have been recalled in the past month due to the potential presence of N-nitrosodimethylamine.


Drug manufacturers recently recalled multiple batches of ranitidine and nizatidine due to concerns that the histamine-2 receptor antagonists were contaminated with N-nitrosodimethylamine (NDMA), a probable carcinogen. None of the recalls have been associated with reports of directly related adverse events.

Appco Pharma LLC recalled all quantities and lots of unexpired ranitidine hydrochloride capsules (150 mg and 300 mg) due to the potential presence of NDMA, the FDA announced on Jan. 7. Recalled products were distributed nationwide.

The FDA announced on Jan. 8 that Mylan Pharmaceuticals recalled three lots of nizatidine capsules USP (150 mg and 300 mg). Trace amounts of NDMA were detected in the active pharmaceutical ingredient, which was manufactured by Solara Active Pharma Sciences Limited, headquartered in India. Recalled batches were distributed nationwide between June 2017 and August 2018.

Finally, the FDA announced on Jan. 8 that there was a recall of all unexpired lots of ranitidine tablets (150 mg and 300 mg) repackaged by Denton Pharma Inc. (doing business as Northwind Pharmaceuticals LLC) in response to the manufacturer's recall. Affected products were distributed directly to Northwind and Crosswind Pharmacy.