Sandoz Recalls 13 Lots of the Muscle Relaxer Orphenadrine

The recall of orphenadrine was due to the presence of the cancer-causing nitrosomine.

Sandoz is recalling 13 lots of oral orphenadrine citrate 100 mg extended-release tablets to the consumer level. The presence of a nitrosamine above acceptable limits was detected in the lots during recent testing, which can lead to cancer. Sandoz has not received any reports of adverse events.

These 13 lots were shipped from August 2019 to April 2021. A list of the lots that are part of the recall can be found here. The product is packaged in 100-count and 1000-count bottles and was distributed nationwide in the USA to wholesalers and distributors.

Orphenadrine is used to relieve pain and discomfort caused by strains, sprains, and other muscle injuries. Orphenadrine is in a class of medications called skeletal muscle relaxants. It works by changing the way the body senses muscle pain.