Drug Safety Alerts

NP Thyroid® 15 mg and 120 mg Tablets Consumer-Level Recall

9/18/2020

On September 18, 2020, Acella Pharmaceuticals issued a consumer-level recall of NP Thyroid® 15 mg and 120 mg tablets. This recall was issued because testing has found products from the affected lots to be sub potent. The product may have as low as 87% of the labeled amount of Levothyroxine (T4).

Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) such as fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In both elderly and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. Acella advises that as of the date of the recall, it has received four reports of adverse events for these lot numbers possibly related to this recall.

NP Thyroid (thyroid tablets, USP) is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid).

A complete list of the affected products can be found here.

Acella Pharmaceuticals, LLC advises that patients should not stop taking their NP Thyroid® 15 mg and 120 mg tablets without first contacting their healthcare provider for further guidance and/or a replacement prescription.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking NP Thyroid® 15 mg and 120 mg tablets to contact their prescriber.

For more information about this recall, please call Acella Pharmaceuticals, LLC toll-free at 1-888-280-2044, Monday through Friday, 8:00 am to 5:00 pm (ET). You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.