Acella Recalls NP Thyroid 15 Tablets Due to Subpotent Levothyroxine
Acella Pharmaceuticals is recalling NP Thyroid 15 tablets because FDA analysis found the levothyroxine content was less than the labeled claim.
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 agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors.
Plain-English summary
Acella Pharmaceuticals, LLC is recalling 19,296 bottles of NP Thyroid 15 (Levothyroxine, Liothyronine) Thyroid Tablets, USP 1/4 grain (15 mg). The affected product is identified by Lot # M327E19-1 with an expiration date of 10/2020. The product was distributed nationwide within the United States.
The recall was initiated because FDA analysis determined that the products were subpotent, meaning they contained less levothyroxine (T4) than stated on the label. This discrepancy means patients may not receive the intended therapeutic dose of the medication.
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 recalled product
- Product
- NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
- Brand
- NP THYROID 15
- Manufacturer
- Acella Pharmaceuticals, LLC
- Category
- Drug — Prescription Drug
- Affected units
- 19,296
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 #: M327E19-1 Exp. 10/2020
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 →Related recalls
Same brand · NP THYROID 15
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Similar recalls
- SevereAcella Recalls Subpotent NP Thyroid 15 Tablets Nationwide
FDA (Drugs) · 2021-06-02
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- CriticalAcella Recalls Superpotent NP Thyroid 15 Thyroid Tablets Nationwide
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