The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0036-2021·Announced 2020-10-28

Acella Recalls NP Thyroid 15 Tablets Due to Subpotent Levothyroxine Levels

Acella Pharmaceuticals is recalling NP Thyroid 15 tablets because FDA analysis found the levothyroxine content was less 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a minimum score of 4 (Severe).

Plain-English summary

Acella Pharmaceuticals, LLC is recalling 9,816 bottles of NP Thyroid 15 (Levothyroxine, Liothyronine) tablets. The affected product is identified by Lot # M328F19-3 with an expiration date of 11/2020. The product was distributed nationwide within the United States.

The recall was initiated because FDA analysis determined that the levothyroxine (T4) portion of the product was subpotent, meaning it contained less of the active ingredient than stated on the label. This discrepancy may result in patients not receiving the intended therapeutic effect of the medication.

Patients and consumers who have this specific lot of NP Thyroid 15 should stop using the product and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The recall is limited to the specific lot number and expiration date listed above.

The recalled product

Product
NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
Brand
NP THYROID 15
Manufacturer
Acella Pharmaceuticals, LLC
Category
Drug — Prescription Medication
Hazard
Affected units
9,816

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 (1)

  • Lot #: M328F19-3 Exp. 11/2020

UPCs (4)

  • 0342192329102
  • 0342192330108
  • 0342192327016
  • 0342192328013

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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