Medications & Supplements/Prescription Drugs

Acella Pharmaceuticals, LLC: NP Thyroid Tablets Recalled Due to Potential Subpotency

Agency Publication Date: May 24, 2021

Summary

Acella Pharmaceuticals is recalling 482,533 bottles of NP Thyroid (thyroid tablets, USP) because routine testing found some lots to be subpotent, meaning they contain less than 90% of the labeled amount of Liothyronine (T3). The recall affects multiple strengths of the medication, including 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg tablets sold in 7-count and 100-count bottles. These prescription medications were distributed nationwide across the United States and Puerto Rico.

Risk

Patients who take subpotent thyroid medication may experience symptoms of hypothyroidism, such as fatigue, weight gain, hair loss, and depression. This risk is especially critical for pregnant women or infants, as low thyroid levels can negatively impact fetal development or growth.

What You Should Do

Check your prescription bottle for the product name 'NP Thyroid' and the National Drug Code (NDC) and lot numbers listed below to see if your medication is affected.
For NP Thyroid 15 (15 mg), look for NDC 42192-327-01 (100-count) with lots M327D20-1, M327D20-3 (Exp. 03/31/2022), M327H19-3A (Exp. 07/31/2021), or M327L19-1 (Exp. 04/30/2021), and NDC 42192-327-07 (7-count) with lot M327D20-1 (Exp. 03/31/2022).
For NP Thyroid 30 (30 mg), look for NDC 42192-329-01 (100-count) with lots M329D20-1, M329D20-2, M329D20-3 (Exp. 03/31/2022), and NDC 42192-329-07 (7-count) with lot M329D20-2 (Exp. 03/31/2022).
For NP Thyroid 60 (60 mg), look for NDC 42192-330-01 with lots M330D20-1, M330D20-2 (Exp. 03/31/2022), M330J19-2A, M330J19-4A, M330J19-5A, M330J19-6A, M330J19-7A, M330J19-9A (Exp. 08/31/2021), M330K19-10, M330K19-1A, or M330K19-9 (Exp. 09/30/2021).
For NP Thyroid 90 (90 mg), look for NDC 42192-331-01 with lots M331J19-10A, M331J19-11, M331J19-2A, M331J19-6A (Exp. 08/31/2021), M331K19-1, M331K19-2, or M331K19-6 (Exp. 09/30/2021).
For NP Thyroid 120 (120 mg), look for NDC 42192-328-01 with lots M328H19-2B, M328J19-11, M328J19-2A, M328J19-3A, M328J19-4A, M328J19-5A, M328J19-6A, M328J19-7A (Exp. 08/31/2021), M328K19-2, or M328K19-4A (Exp. 09/30/2021), and NDC 42192-328-07 with lot M328J19-9B (Exp. 08/31/2021).
Contact your healthcare provider or pharmacist immediately for guidance if you are using an affected lot; do not stop taking the medication without a replacement, as thyroid management is essential.
Return any unused tablets from affected lots to your pharmacy for a refund and contact Acella Pharmaceuticals at 1-888-723-3332 if you have further questions.
For additional questions or to report a side effect, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls

Your Remedy Options

Full Refund

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

M327D20-1

M327D20-3 (Exp. 03/31/2022)

M327H19-3A (Exp. 07/31/2021)

M327L19-1 (Exp. 04/30/2021)

Date Ranges: Exp. 03/31/2022, Exp. 07/31/2021, Exp. 04/30/2021

Product: NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), 7-count bottles

Model:

NDC 42192-327-07

Lot Numbers:

M327D20-1 (Exp. 03/31/2022)

Date Ranges: Exp. 03/31/2022

Product: NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), 100-count bottles

Model:

NDC 42192-329-01

Lot Numbers:

M329D20-1

M329D20-2

M329D20-3 (Exp. 03/31/2022)

Date Ranges: Exp. 03/31/2022

Product: NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), 7-count bottles

Model:

NDC 42192-329-07

Lot Numbers:

M329D20-2 (Exp. 03/31/2022)

Date Ranges: Exp. 03/31/2022

Product: NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg), 100-count bottles

Model:

NDC 42192-330-01

Lot Numbers:

M330D20-1

M330D20-2 (Exp. 03/31/2022)

M330J19-2A (Exp. 08/31/2021)

M330J19-4A (Exp. 08/31/2021)

M330J19-5A (Exp. 08/31/2021)

M330J19-6A (Exp. 08/31/2021)

M330J19-7A (Exp. 08/31/2021)

M330J19-9A (Exp. 08/31/2021)

M330K19-10 (Exp. 09/30/2021)

M330K19-1A (Exp. 09/30/2021)

M330K19-9 (Exp. 09/30/2021)

Date Ranges: Exp. 03/31/2022, Exp. 08/31/2021, Exp. 09/30/2021

Product: NP Thyroid 90 Thyroid Tablets, USP 1 1/2 grain (90 mg), 100-count bottles

Model:

NDC 42192-331-01

Lot Numbers:

M331J19-10A (Exp. 08/31/2021)

M331J19-11 (Exp. 08/31/2021)

M331J19-2A (Exp. 08/31/2021)

M331J19-6A (Exp. 08/31/2021)

M331K19-1 (Exp. 09/30/2021)

M331K19-2 (Exp. 09/30/2021)

M331K19-6 (Exp. 09/30/2021)

Date Ranges: Exp. 08/31/2021, Exp. 09/30/2021

Product: NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), 100-count bottles

Model:

NDC 42192-328-01

Lot Numbers:

M328H19-2B (Exp. 08/31/2021)

M328J19-11 (Exp. 08/31/2021)

M328J19-2A (Exp. 08/31/2021)

M328J19-3A (Exp. 08/31/2021)

M328J19-4A (Exp. 08/31/2021)

M328J19-5A (Exp. 08/31/2021)

M328J19-6A (Exp. 08/31/2021)

M328J19-7A (Exp. 08/31/2021)

M328K19-2 (Exp. 09/30/2021)

M328K19-4A (Exp. 09/30/2021)

Date Ranges: Exp. 08/31/2021, Exp. 09/30/2021

Product: NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), 7-count bottles

Model:

NDC 42192-328-07

Lot Numbers:

M328J19-9B (Exp. 08/31/2021)

Date Ranges: Exp. 08/31/2021

Product Images

Image 2 - Labeling, NP Thyroid 15

Labeling, NP Thyroid 30

Labeling, NP Thyroid 60

Labeling, NP Thyroid 90

Labeling, NP Thyroid 120

Labeling, NP Thyroid 15, professional sample

Labeling, NP Thyroid 30, professional sample

Labeling, NP Thyroid 120, professional sample

Photo, NP Thyroid 15mg

Photo, NP Thyroid 30 mg

Photo, NP Thyroid 60 mg

Photo, NP Thyroid 90 mg

Photo, NP Thyroid 120 mg

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87843

Status: Resolved

Manufacturer: Acella Pharmaceuticals, LLC

Sold By: pharmacies

Manufactured In: United States

Units Affected: 5 products (a) 66,155 bottles; b) 26,212 bottles; a) 113,019 bottles; b) 44,900 bottles; 154,726 bottles; 79,344 bottles; a) 69,289 bottles; b) 9,076 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.

Summary

What You Should Do

Check your prescription bottle for the product name 'NP Thyroid' and the National Drug Code (NDC) and lot numbers listed below to see if your medication is affected.

For NP Thyroid 15 (15 mg), look for NDC 42192-327-01 (100-count) with lots M327D20-1, M327D20-3 (Exp. 03/31/2022), M327H19-3A (Exp. 07/31/2021), or M327L19-1 (Exp. 04/30/2021), and NDC 42192-327-07 (7-count) with lot M327D20-1 (Exp. 03/31/2022).

For NP Thyroid 30 (30 mg), look for NDC 42192-329-01 (100-count) with lots M329D20-1, M329D20-2, M329D20-3 (Exp. 03/31/2022), and NDC 42192-329-07 (7-count) with lot M329D20-2 (Exp. 03/31/2022).

For NP Thyroid 60 (60 mg), look for NDC 42192-330-01 with lots M330D20-1, M330D20-2 (Exp. 03/31/2022), M330J19-2A, M330J19-4A, M330J19-5A, M330J19-6A, M330J19-7A, M330J19-9A (Exp. 08/31/2021), M330K19-10, M330K19-1A, or M330K19-9 (Exp. 09/30/2021).

For NP Thyroid 90 (90 mg), look for NDC 42192-331-01 with lots M331J19-10A, M331J19-11, M331J19-2A, M331J19-6A (Exp. 08/31/2021), M331K19-1, M331K19-2, or M331K19-6 (Exp. 09/30/2021).

For NP Thyroid 120 (120 mg), look for NDC 42192-328-01 with lots M328H19-2B, M328J19-11, M328J19-2A, M328J19-3A, M328J19-4A, M328J19-5A, M328J19-6A, M328J19-7A (Exp. 08/31/2021), M328K19-2, or M328K19-4A (Exp. 09/30/2021), and NDC 42192-328-07 with lot M328J19-9B (Exp. 08/31/2021).

Contact your healthcare provider or pharmacist immediately for guidance if you are using an affected lot; do not stop taking the medication without a replacement, as thyroid management is essential.

Return any unused tablets from affected lots to your pharmacy for a refund and contact Acella Pharmaceuticals at 1-888-723-3332 if you have further questions.

For additional questions or to report a side effect, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls

Affected Products

Product: NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), 100-count bottles

Model:

NDC 42192-327-01

Lot Numbers:

M327D20-1

M327D20-3 (Exp. 03/31/2022)

M327H19-3A (Exp. 07/31/2021)

M327L19-1 (Exp. 04/30/2021)

Date Ranges: Exp. 03/31/2022, Exp. 07/31/2021, Exp. 04/30/2021

Product: NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), 7-count bottles

Model:

NDC 42192-327-07

Lot Numbers:

M327D20-1 (Exp. 03/31/2022)

Date Ranges: Exp. 03/31/2022

Product: NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), 100-count bottles

Model:

NDC 42192-329-01

Lot Numbers:

M329D20-1

M329D20-2

M329D20-3 (Exp. 03/31/2022)

Date Ranges: Exp. 03/31/2022

Product: NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), 7-count bottles

Model:

NDC 42192-329-07

Lot Numbers:

M329D20-2 (Exp. 03/31/2022)

Date Ranges: Exp. 03/31/2022

Product: NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg), 100-count bottles

Model:

NDC 42192-330-01

Lot Numbers:

M330D20-1

M330D20-2 (Exp. 03/31/2022)

M330J19-2A (Exp. 08/31/2021)

M330J19-4A (Exp. 08/31/2021)

M330J19-5A (Exp. 08/31/2021)

M330J19-6A (Exp. 08/31/2021)

M330J19-7A (Exp. 08/31/2021)

M330J19-9A (Exp. 08/31/2021)

M330K19-10 (Exp. 09/30/2021)

M330K19-1A (Exp. 09/30/2021)

M330K19-9 (Exp. 09/30/2021)

Date Ranges: Exp. 03/31/2022, Exp. 08/31/2021, Exp. 09/30/2021

Product: NP Thyroid 90 Thyroid Tablets, USP 1 1/2 grain (90 mg), 100-count bottles

Model:

NDC 42192-331-01

Lot Numbers:

M331J19-10A (Exp. 08/31/2021)

M331J19-11 (Exp. 08/31/2021)

M331J19-2A (Exp. 08/31/2021)

M331J19-6A (Exp. 08/31/2021)

M331K19-1 (Exp. 09/30/2021)

M331K19-2 (Exp. 09/30/2021)

M331K19-6 (Exp. 09/30/2021)

Date Ranges: Exp. 08/31/2021, Exp. 09/30/2021

Product: NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), 100-count bottles

Model:

NDC 42192-328-01

Lot Numbers:

M328H19-2B (Exp. 08/31/2021)

M328J19-11 (Exp. 08/31/2021)

M328J19-2A (Exp. 08/31/2021)

M328J19-3A (Exp. 08/31/2021)

M328J19-4A (Exp. 08/31/2021)

M328J19-5A (Exp. 08/31/2021)

M328J19-6A (Exp. 08/31/2021)

M328J19-7A (Exp. 08/31/2021)

M328K19-2 (Exp. 09/30/2021)

M328K19-4A (Exp. 09/30/2021)

Date Ranges: Exp. 08/31/2021, Exp. 09/30/2021

Product: NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), 7-count bottles

Model:

NDC 42192-328-07

Lot Numbers:

M328J19-9B (Exp. 08/31/2021)

Date Ranges: Exp. 08/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87843

Status: Resolved

Manufacturer: Acella Pharmaceuticals, LLC

Sold By: pharmacies

Manufactured In: United States

Units Affected: 5 products (a) 66,155 bottles; b) 26,212 bottles; a) 113,019 bottles; b) 44,900 bottles; 154,726 bottles; 79,344 bottles; a) 69,289 bottles; b) 9,076 bottles)

Distributed To: Nationwide