The Recall Desk
CriticalFDA (Drugs)·D-0395-2021·Announced 2021-06-02

Acella Recalls Subpotent NP Thyroid 15 Tablets Nationwide

Acella Pharmaceuticals is recalling NP Thyroid 15 tablets because they contain less active ingredient than labeled. The recall covers bottles distributed nationwide.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA classified this recall as Class I, which per the rubric mandates a severity score of 5 (Critical) regardless of other factors.

Plain-English summary

Acella Pharmaceuticals, LLC is voluntarily recalling NP Thyroid 15 Thyroid Tablets, USP. The recall was initiated on April 29, 2021, because the tablets were found to be subpotent, meaning they contain less of the active ingredients levothyroxine and liothyronine than stated on the label.

The affected product is packaged in 100-count bottles (NDC 42192-327-01) and 7-count bottles (NDC 42192-327-07). The recall includes specific lots with expiration dates ranging from April 30, 2021, to March 31, 2022. A total of 66,155 bottles of the 100-count size and 26,212 bottles of the 7-count size are involved.

The product was distributed nationwide within the United States, including Puerto Rico. The FDA classified this as a Class I recall, which is the most serious type, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death. Patients should stop using the recalled product and consult their healthcare provider for alternative treatment.

The recalled product

Product
NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
Brand
NP THYROID 15
Manufacturer
Acella Pharmaceuticals, LLC
Category
Drug — Thyroid Hormone
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lots: a) M327D20-1
  • M327D20-3 Exp. 03/31/2022
  • M327H19-3A Exp. 07/31/2021
  • M327L19-1 Exp. 04/30/2021
  • b) M327D20-1 Exp. 03/31/2022

UPCs (4)

  • 0342192329102
  • 0342192330108
  • 0342192327016
  • 0342192328013

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Acella Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same brand · NP THYROID 15

Same manufacturer · Acella Pharmaceuticals, LLC

See all →

Same hazard · subpotent drug

See all →