The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-1300-2020·Announced 2020-06-10

Acella Recalls Superpotent NP Thyroid 15 Thyroid Tablets Nationwide

Acella Pharmaceuticals is voluntarily recalling 49,128 bottles of NP Thyroid 15 tablets because they are superpotent. The FDA classified this as a Class I recall.

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 meets the rubric criteria for a Critical severity score (5).

Plain-English summary

Acella Pharmaceuticals, LLC is voluntarily recalling 49,128 bottles of NP Thyroid 15 (Levothyroxine, Liothyronine) tablets. The product is a prescription-only thyroid medication manufactured in Alpharetta, Georgia, and distributed nationwide in the United States and Puerto Rico. The specific lots affected are M331G18-1, M331J18-1, M331J18-2, M331M18-1, and M331M18-2, with expiration dates ranging from June 2020 to November 2020.

The reason for the recall is that the drug is superpotent, meaning it contains a higher concentration of the active ingredient than intended. The FDA has classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The recall was initiated by the firm on May 22, 2020, and was terminated on January 19, 2022.

Patients who have been prescribed this medication should contact their healthcare provider for guidance on alternative treatments or further instructions. Consumers should check their medication bottles for the specific lot numbers and expiration dates listed above to determine if they are affected.

The recalled product

Product
NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
Brand
NP THYROID 15
Manufacturer
Acella Pharmaceuticals, LLC
Category
Drug — Thyroid Medication
Hazard
Affected units
49,128

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 (6)

  • Lots: M331G18-1 Exp. JUN-2020
  • M331J18-1
  • M331J18-2
  • Exp. AUG-2020
  • M331M18-1
  • M331M18-2 Exp. NOV-2020

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 3 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 3 products in this recall →

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