The Recall Desk
SevereFDA (Drugs)·D-0399-2021·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

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 (Severe) or higher.

Plain-English summary

Acella Pharmaceuticals, LLC is voluntarily recalling NP Thyroid 15 (levothyroxine, liothyronine) 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 consists of NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in 100-count bottles (NDC 42192-328-01) and 7-count bottles (NDC 42192-328-07). A total of 69,289 100-count bottles and 9,076 7-count bottles were distributed nationwide within the United States, including Puerto Rico. Specific lot numbers and expiration dates are listed in the official recall notice.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall was initiated by the firm and is currently terminated.

The recalled product

Product
NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
Brand
NP THYROID 15
Manufacturer
Acella Pharmaceuticals, LLC
Category
Drug — Prescription Drug
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 (12)

  • Lot #: a) M328H19-2B
  • M328J19-11
  • M328J19-2A
  • M328J19-3A
  • M328J19-4A M328J19-5A
  • M328J19-6A
  • M328J19-7A
  • Exp. 08/31/2021
  • M328K19-2
  • M328K19-4A
  • Exp. 09/30/2021
  • b) M328J19-9B Exp. 08/31/2021

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 →

Related recalls

Same brand · NP THYROID 15

Same manufacturer · Acella Pharmaceuticals, LLC

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Same hazard · subpotent drug

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