Class I Recall Issued for Subpotent Thyroid Medication

Dozens of lots of subpotent NP Thyroid tablets manufactured for Acella Pharmaceuticals are included in a Class I recall in the June 2, 2021, US Food and Drug Administration (FDA) Enforcement Report. The classification signals use of the affected tablets could cause serious adverse health consequences or death. 

“Patients being treated for hypothyroidism (underactive thyroid) who receive subpotent NP Thyroid may experience signs and symptoms of hypothyroidism (underactive thyroid)…” Acella Pharmaceuticals stated in an April 30, 2021, company announcement. “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 elderly patients and patients with underlying cardiac disease, toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations, or cardiac arrhythmia.” 

As of the April 30, 2021, announcement, the firm had received 43 reports of serious adverse events potentially linked with the affected tablets.  

The recall includes the following products, distributed throughout the United States and in Puerto Rico:

• NP Thyroid 15 mg, 100-count bottles (NDC 42192-327-01), from lots M327D20-1 and M327D20-3 (Exp. 3/31/22), M327H19-3A (Exp. 7/31/21), and M327L19-1 (Exp. 4/30/21);
• NP Thyroid 15 mg, 7-count bottles (NDC 42192-327-07), from lot M327D20-1 (Exp. 3/31/22);
• NP Thyroid 30 mg, 100-count bottles (NDC 42192-329-01), from lots M329D20-1, M329D20-2, and M329D20-3 (Exp. 3/31/22);
• NP Thyroid 30 mg, 7-count bottles (NDC 42192-329-07), from lot M329D20-2 (Exp. 03/31/22);
• NP Thyroid 60 mg, 100-count bottles (NDC 42192-330-01), from lots M330D20-1 and M330D20-2 (Exp. 3/31/22), M330J19-2A, M330J19-4A, M330J19-5A, M330J19-6A, M330J19-7A, and M330J19-9A (Exp. 8/31/21), and M330K19-10, M330K19-1A, and M330K19-9 (Exp. 9/30/21);
• NP Thyroid 90 mg, 100-count bottles (NDC 42192-331-01), from lots M331J19-10A, M331J19-11, M331J19-2A, and M331J19-6A (Exp. 8/31/21), and M331K19-1, M331K19-2, and M331K19-6 (Exp. 9/30/21);
• NP Thyroid 120 mg, 100-count bottles (NDC 42192-328-01), from lots M328H19-2B, M328J19-11, M328J19-2A, M328J19-3A, M328J19-4A, M328J19-5A, M328J19-6A, and M328J19-7A (Exp. 8/31/21), and M328K19-2 and M328K19-4A (Exp. 9/30/21); and
• NP Thyroid 120 mg, 7-count bottles (NDC 42192-328-07), from lots M328J19-9B (Exp. 8/31/21).

Acella Pharmaceuticals voluntarily initiated the recall April 29, 2021. The FDA designated the recall Class I on May 24, 2021.

Composed of levothyroxine and liothyronine, NP Thyroid is available with a prescription to treat hypothyroidism.