Heartburn Medication Recall 2020: More Acid Reflux Medications Recalled Over Cancer Concerns

After a string of heartburn medications were recalled over the last few months at the urgency of the Food & Drug Administration (FDA), Amneal Pharmaceuticals, LLC (AMRX) has recalled three lots of it Nizatidine Oral Solution, a heartburn and ulcer medicine, because it may cause cancer.

The affected Nizatidine Oral Solution was recalled because it may contain N-Nitrosodimethylamine (NDMA) in levels that exceed the acceptable limits set by the FDA. NDMA is classified as a probable human carcinogen that could cause cancer.

The recall affects 15mg/mL (75 mg/5mL) Nizatidine Oral Solutions packaged in 480 mL bottles. The NDC number for the recalled medication is 60846-301-15 with lot numbers that include 06598004A, 06599001A, and 06599002A. Expiration dates are 04/2020, 12/2020, and 12/2020, respectively.

The affected medication was distributed directly to wholesalers by Gemini Laboratories, LLC, which is a wholly owned subsidiary of Amneal Pharmaceuticals, and sold to retail pharmacies and consumers nationwide. Labels of the recalled medication can be viewed here.

Consumers that have the affected Nizatidine Oral Solution should stop using the medication. They should call Inmar at 1-855-319-4807, Monday through Friday from 8 a.m. to 6 p.m. EST or by email at DrugSafety@amneal.com.

Adverse reactions from the medication can be reported to Amneal Drug Safety at 1-877-835-5472, Monday through Friday from 8 a.m. to 6 p.n EST or by email at DrugSafety@amneal.com.

Consumers should contact their physician or healthcare provider if they experience any problems related to taking the recalled medication. The company has not received any reports of adverse reactions due to the recall of the heartburn medication.

Shares of Amneal Pharmaceuticals stock were down 3.5714% as of 11:06 a.m. EDT on Thursday.