Since late September, 10 recalls have been issued by manufacturers of generic ranitidine tablets, capsules, and syrups because of contamination by N-nitrosodimethylamine (NDMA). Three recalls have occurred so far in November.
The FDA detected NDMA, considered a probable carcinogen, in ranitidine products in September, following identification of widespread NDMA contamination in generic angiotensin II receptor blockers (ARBs) over the last year.
The agency began testing additional medications for NDMA in August, with a particular focus on those that used manufacturing processes similar to ARBs. The agency posted results of initial testing at the beginning of November and encouraged companies to conduct their own testing and voluntarily recall products that exceeded the acceptable daily intake limit for NDMA of 96 nanograms per day or 0.32 parts per million for ranitidine.
The FDA announced recalls by two companies on November 12. American Health Packaging voluntarily recalled eight lots of ranitidine syrup liquid-dose cups repackaged under its name. The cups are made by Lannett Company. Amneal issued an extensive recall for its prescription ranitidine hydrochloride tables, both 150-mg and 300-mg dosages, and its 15-mg/dL syrup. Affected lots have expiration dates between March 31, 2020 and April 30, 2021.
Earlier in the month, Aurobindo Pharma recalled its generic 150-mg OTC ranitidine tablets as well as both strengths (150 mg and 300 mg) of its prescription ranitidine capsules and its 15-mg/mL ranitidine syrup. The Amneal and Aurobindo recalls noted that the products contained unacceptable levels of NDMA.
In October, Perrigo Company halted distribution of its generic tables and issued a voluntary, worldwide product recall at the retail-customer level. Novitium Pharma also voluntarily recalled all quantities and lots of its 150-mg and 300-mg ranitidine capsules to the consumer level. Lannett recalled all unexpired lots of prescription ranitidine syrup after confirming the presence of NDMA. Dr. Reddy’s Laboratories recalled both prescription and OTC versions of its tablets and capsules, and Sanofi recalled its OTC ranitidine products.
In late September, Apotex recalled its OTC 75-mg and 150-mg tablets and Sandoz recalled its prescription ranitidine capsules.
FDA testing found the highest levels of NDMA contamination in products made by Novitium, Sanofi, Amneal, and Aurobindo, which all had lots that exceeded the recommended levels by at least six-fold. The agency has not posted results for all manufacturers.
Ranitidine is a histamine-2 blocker that reduces production of stomach acid. Prescription versions of the drug treat and prevent gastrointestinal ulcers and gastroesophageal reflux disease. OTC versions are marketed for relief and prevention of heartburn resulting from acid ingestion and “sour stomach.”
For consumers concerned about continuing to take ranitidine, pharmacists may recommend substituting a number of other products, include famotidine, cimetidine, esomeprazole, lansoprazole, and omeprazole. The FDA has found no NDMA in these products.
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