The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0398-2021·Announced 2021-06-02

Acella Pharmaceuticals Recalls Subpotent NP Thyroid 15 Prescription Tablets

Acella Pharmaceuticals is recalling 79,344 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 recall is classified as FDA 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 79,344 bottles of NP Thyroid 15 (Levothyroxine, Liothyronine) 90 mg tablets. The recall was initiated because the product is subpotent, meaning it contains less of the active drug ingredients than stated on the label.

The affected product is distributed nationwide within the United States, including Puerto Rico. The specific lots involved are M331J19-10A, M331J19-11, M331J19-2A, M331J19-6A (expiring 08/31/2021), and M331K19-1, M331K19-2, M331K19-6 (expiring 09/30/2021). The recall was initiated on April 29, 2021, and was classified as Class I by the FDA.

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 distributor for disposal or credit. Patients should consult their healthcare provider regarding alternative treatment options if they have been using the recalled product.

The recalled product

Product
NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
Brand
NP THYROID 15
Manufacturer
Acella Pharmaceuticals, LLC
Category
Drug — Prescription Medication
Hazard
Affected units
79,344

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 (9)

  • Lots: M331J19-10A
  • M331J19-11
  • M331J19-2A
  • M331J19-6A
  • Exp. 08/31/2021
  • M331K19-1
  • M331K19-2
  • M331K19-6
  • 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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