Acella LLC is recalling specific lots of 15 mg and 120 mg levothyroxine (T4) and liothyronine (T3) thyroid tablets, USP (NP Thyroid) due to sub potency identified during testing. The product may have as low as 87% of the labeled amount of levothyroxine (T4). The affected lots include one NP Thyroid® 15 mg (Lot #M327E19-1; Exp. Date – October 2020) and one NP Thyroid® 120 mg (Lot #M328F19-1; Exp. Date – November 2020).
Patients who received sub potent levothyroxine (t4) and liothyronine (t3) thyroid tablets, USP may experience signs and symptoms of hypothyroidism (underactive thyroid). Signs and symptoms of hypothyroidism include constipation, puffy face, slow heart rate, hair loss, increased sensitivity to cold, fatigue, dry skin, swelling of the thyroid gland, depression and/or difficulty losing weight or unexplained weight gain.
There is reasonable risk of serious injury in special populations with hypothyroidism. Risk in pregnant women include early miscarriage. Newborn infants may develop fetal hyperthyroidism and/or impairments to fetal neural and skeletal developments. Elderly patients may experience cardiac pain, palpitations, or cardiac arrhythmia.
Patients who are currently taking levothyroxine (T4) and liothyronine (T3) thyroid tablets, USP from the lots being recalled should not abruptly stop the medication. Patients should contact their healthcare provider for further guidance and/or a replacement prescription.
Patients and healthcare providers can report any adverse reaction related to subpotent NP Thyroid® products to the FDA’s MedWatch program in 1 of 2 ways.
- Submit a report online at www.fda.gov/medwatch/report.htm
- Complete a paper form and fax to 1-800-FDA-0178
Additional information is available at the following links: