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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Acella Pharmaceuticals, LLC: NP Thyroid Tablets Recalled for Low Levothyroxine (T4) Levels

Agency Publication Date: October 19, 2020
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Summary

Acella Pharmaceuticals is recalling approximately 29,112 bottles of NP Thyroid (levothyroxine/liothyronine) tablets because they are subpotent. Testing found that these tablets contain less than the required amount of levothyroxine (T4), which is the active hormone intended to treat thyroid conditions. The recall affects 100-count bottles of both NP Thyroid 15 and NP Thyroid 120 that were distributed nationwide. If you have this medication, you should consult your healthcare provider or pharmacist before you stop taking it, as an untreated underactive thyroid can lead to serious health complications.

Risk

Because these tablets contain less active medication than labeled, patients may not receive enough thyroid hormone. This can lead to symptoms of hypothyroidism, such as extreme fatigue, weight gain, hair loss, depression, and increased sensitivity to cold.

What You Should Do

  1. Check your medication bottle to see if you have NP Thyroid 15 (15 mg tablets) with NDC 42192-327-01, Lot M327E19-1, and an expiration date of 10/2020.
  2. Check your medication bottle to see if you have NP Thyroid 120 (120 mg tablets) with NDC 42192-328-01, Lot M328F19-3, and an expiration date of 11/2020.
  3. Do not stop taking your medication immediately; contact your doctor or healthcare provider right away to discuss a replacement prescription or alternative treatment.
  4. Return any unused tablets from these specific lots to your pharmacy to receive a refund.
  5. Contact Acella Pharmaceuticals for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: NP Thyroid 15, Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles
Model:
NDC 42192-327-01
Lot Numbers:
M327E19-1 (Exp. 10/2020)
Date Ranges: Expiration date 10/2020
Product: NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles
Model:
NDC 42192-328-01
Lot Numbers:
M328F19-3 (Exp. 11/2020)
Date Ranges: Expiration date 11/2020

Product Images

15 mg tablet picture

15 mg tablet picture

120 mg tablet picture

120 mg tablet picture

NPThyroid15, Thyroid Tablets, USP, ¼ grain (15 mg), 100 tablets, front label

NPThyroid15, Thyroid Tablets, USP, ¼ grain (15 mg), 100 tablets, front label

NPThyroid120, Thyroid Tablets, USP, 2 grain (120 mg), 100 tablets, front label

NPThyroid120, Thyroid Tablets, USP, 2 grain (120 mg), 100 tablets, front label

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86467
Status: Resolved
Manufacturer: Acella Pharmaceuticals, LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (19,296 bottles; 9816 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.