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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Acella Pharmaceuticals, LLC: NP Thyroid Tablets Recalled Due to Superpotency Risk

Agency Publication Date: June 2, 2020
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Summary

Acella Pharmaceuticals, LLC is recalling 190,572 bottles of NP Thyroid (thyroid tablets, USP) in 30 mg, 60 mg, and 90 mg dosages because testing found the tablets to be superpotent, meaning they contain more active ingredient than specified. Taking a higher dose of thyroid hormone than intended can lead to serious health complications. These prescription-only medications were distributed nationwide across the United States and Puerto Rico in 100-count bottles. Consumers should speak with their doctor or pharmacist immediately before making any changes to their medication regimen, as stopping thyroid treatment abruptly can also pose health risks.

Risk

The superpotent medication can cause symptoms of hyperthyroidism, including weight loss, heat intolerance, fatigue, muscle weakness, and heart palpitations. In elderly patients or individuals with underlying heart conditions, this excess thyroid hormone can lead to dangerous cardiac issues such as heart failure or irregular heartbeats.

What You Should Do

  1. Check your prescription bottle for NP Thyroid (thyroid tablets, USP) in the 30 mg, 60 mg, or 90 mg strengths to see if the lot number and expiration date match the affected products.
  2. For NP Thyroid 30 mg (1/2 grain), look for NDC 42192-329-01 and lot numbers M329H18-1 (Exp. JUL-2020); M329J18-1, M329J18-2, M329J18-3 (Exp. AUG-2020); M329M18-2 (Exp. NOV-2020); or M329A19-1 (Exp. DEC-2020).
  3. For NP Thyroid 60 mg (1 grain), look for NDC 42192-330-01 and lot numbers M330J18-2A or M330J18-3 (both Exp. AUG-2020).
  4. For NP Thyroid 90 mg (1 1/2 grain), look for NDC 42192-331-01 and lot numbers M331G18-1 (Exp. JUN-2020); M331J18-1, M331J18-2 (Exp. AUG-2020); or M331M18-1, M331M18-2 (Exp. NOV-2020).
  5. Do NOT stop taking your medication until you have spoken with your healthcare provider or pharmacist, as stopping thyroid treatment abruptly can cause serious health issues.
  6. Contact your healthcare provider or pharmacist for guidance on obtaining a safe replacement and return any unused recalled product to your pharmacy for a refund.
  7. Contact Acella Pharmaceuticals, LLC for further instructions or to report concerns at the address 1880 McFarland Pkwy Ste 110-B, Alpharetta, GA 30005.
  8. For additional questions, call the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund for unused medication

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 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottle
Model:
NDC 42192-329-01
Recall #: D-1298-2020
Lot Numbers:
M329H18-1 (Exp. JUL-2020)
M329J18-1 (Exp. AUG-2020)
M329J18-2 (Exp. AUG-2020)
M329J18-3 (Exp. AUG-2020)
M329M18-2 (Exp. NOV-2020)
M329A19-1 (Exp. DEC-2020)
Date Ranges: JUL-2020, AUG-2020, NOV-2020, DEC-2020
Product: NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottle
Model:
NDC 42192-330-01
Recall #: D-1299-2020
Lot Numbers:
M330J18-2A (Exp. AUG-2020)
M330J18-3 (Exp. AUG-2020)
Date Ranges: AUG-2020
Product: NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottle
Model:
NDC 42192-331-01
Recall #: D-1300-2020
Lot Numbers:
M331G18-1 (Exp. JUN-2020)
M331J18-1 (Exp. AUG-2020)
M331J18-2 (Exp. AUG-2020)
M331M18-1 (Exp. NOV-2020)
M331M18-2 (Exp. NOV-2020)
Date Ranges: JUN-2020, AUG-2020, NOV-2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85721
Status: Resolved
Manufacturer: Acella Pharmaceuticals, LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 3 products (112,140 bottles; 29,304 bottles; 49,128 bottles)
Distributed To: Nationwide
Agency Last Updated: June 8, 2020

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.

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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 ยท 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.