Drug Safety Alerts

NP Thyroid Tablets Consumer-Level Recall

5/28/2020

On May 28, 2020, we received a consumer-level recall notice from Acella Pharmaceuticals regarding NP Thyroid® 30 mg, 60 mg and 90 mg tablets. This recall was issued because testing has found products from the affected lots to be superpotent. The product may have up to 115.0% of the labeled amount of Liothyronine (T3).

A complete list of the affected products is provided here.

Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances. Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development. Patients should talk to their healthcare professional before they stop taking their NP Thyroid medicine. To date, Acella has received two reports of adverse events known to be related to this recall.

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

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 30 mg, 60 mg and 90 mg tablets to contact their prescriber.

For more information about this recall, contact Acella Customer Service at 1-800-541-4802, Monday through Thursday, 9:00 am to 5:00 pm (ET) and Friday, 9:00 am to 12:30 pm (ET). You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.