PhotoLannett Company is recalling all lots of Ranitidine Syrup.

The product is contaminated with N-Nitrosodimethylamine (NDMA), a probable human carcinogen, above levels established by the FDA.

The recalled product is used as a short-term treatment for active duodenal ulcers, maintenance therapy for duodenal ulcer patients, treatment of pathological hypersecretory conditions, short-term treatment of active, benign gastric ulcers, maintenance therapy for gastric ulcers, treatment of GERD and treatment of endoscopically diagnosed erosive esophagitis.

The following lots of the product, packaged in bottles of 16 fluid ounces (one pint) (NDC 54838-550-80), are being recalled:

NDC CodeBatch   Expiration Date NDC Code Batch Expiration Date
54838-550-801503A10/201954838-550-801646A02/2020
54838-550-801504A10/201954838-550-801647A02/2020
54838-550-801505A10/201954838-550-801668A03/2020
54838-550-801523A10/201954838-550-801669A03/2020
54838-550-801524A10/201954838-550-801670A03/2020
54838-550-801525A11/201954838-550-801708A03/2020
54838-550-801561A12/201954838-550-801709A04/2020
54838-550-801562A12/201954838-550-801710A04/2020
54838-550-801563A12/201954838-550-801729A04/2020
54838-550-801589A12/201954838-550-801730A04/2020
54838-550-801590A12/201954838-550-801731A04/2020
54838-550-801591A12/201954838-550-801757A05/2020
54838-550-801614A01/202054838-550-801758A05/2020
54838-550-801615A01/202054838-550-801759A05/2020
54838-550-801617A01/202054838-550-801773A06/2020
54838-550-801644A02/202054838-550-801774A06/2020
54838-550-801775A06/202054838-550-801989A12/2020
54838-550-801794A06/202054838-550-801990A12/2020
54838-550-801795A06/202054838-550-801991A12/2020
54838-550-801796A06/202054838-550-801998A01/2021
54838-550-801817A06/202054838-550-801999A01/2021
54838-550-801818A07/202054838-550-802000A01/2021
54838-550-801819A07/202054838-550-802019A01/2021
54838-550-801840A08/202054838-550-802020A01/2021
54838-550-801840B08/202054838-550-802065A03/2021
54838-550-801841A08/202054838-550-802066A03/2021
54838-550-801842A08/202054838-550-802067A03/2021
54838-550-801863A08/202054838-550-802071A03/2021
54838-550-801864A09/202054838-550-802072A03/2021
54838-550-801865A09/202054838-550-802073A03/2021
54838-550-801899A10/202054838-550-802076A03/2021
54838-550-801900A10/202054838-550-802077A03/2021
54838-550-801901A10/202054838-550-802078A03/2021
54838-550-801910A10/202054838-550-802126A05/2021
54838-550-801911A10/202054838-550-802127A05/2021
54838-550-801912A10/202054838-550-802128A05/2021
54838-550-801918A10/202054838-550-802164A06/2021
54838-550-801919A10/202054838-550-802165A06/2021
54838-550-801920A10/202054838-550-802166A06/2021
54838-550-801925A10/202054838-550-802179A06/2021
54838-550-801926A10/202054838-550-802180A07/2021
54838-550-801927A10/202054838-550-802181A07/2021
54838-550-801977A12/202054838-550-802214A08/2021
54838-550-801978A12/202054838-550-802215A08/2021
54838-550-801979A12/202054838-550-802216A08/2021

The recalled product was distributed nationwide to wholesalers/distributors.

What to do

Patients should contact their physician or healthcare provider if they have any problems that may be related to taking or using the recalled product.

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