The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0397-2021·Announced 2021-06-02

Acella Recalls Subpotent NP Thyroid 15 Tablets Nationwide

Acella Pharmaceuticals is recalling 154,726 bottles of NP Thyroid 15 tablets because they contain less active ingredient than labeled.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA classified this recall as Class I, which is the highest severity level indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

Plain-English summary

Acella Pharmaceuticals, LLC is voluntarily recalling 154,726 bottles of NP Thyroid 15 (Levothyroxine, Liothyronine) tablets. The recall was initiated on April 29, 2021, and is classified as Class I by the FDA. The product is a prescription-only medication manufactured in Alpharetta, Georgia.

The reason for the recall is that the tablets are subpotent, meaning they contain less of the active thyroid hormone ingredients than stated on the label. The affected lots include M330D20-1, M330D20-2, M330J19-2A, M330J19-4A, M330J19-5A, M330J19-6A, M330J19-7A, M330J19-9A, M330K19-10, M330K19-1A, and M330K19-9. These lots have expiration dates ranging from August 31, 2021, to March 31, 2022.

The recalled product was distributed nationwide within the United States, including Puerto Rico. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the pharmacy or healthcare provider for disposal or replacement. The recall status is currently terminated.

The recalled product

Product
NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
Brand
NP THYROID 15
Manufacturer
Acella Pharmaceuticals, LLC
Category
Drug — Thyroid Hormone
Hazard
Affected units
154,726

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 (11)

  • Lots: M330D20-1
  • M330D20-2 Exp. 03/31/2022
  • M330J19-2A
  • M330J19-4A
  • M330J19-5A
  • M330J19-6A
  • M330J19-7A
  • M330J19-9A Exp. 08/31/2021
  • M330K19-10
  • M330K19-1A
  • M330K19-9 Exp. 09/30/2021

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 →

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