Lower risk Drug recall · FDA · Published April 29, 2021

Acella NP Thyroid 120 Tablets Recall: Subpotent Drug Risk

Acella Pharmaceuticals recalls NP Thyroid 120 tablets (120 mg) due to subpotent drug content. These tablets may not provide the intended thyroid hormone levels. Affected lots expired by August 2021.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0399-2021Drug Acella Pharmaceuticals ›

Lower-risk recall

Subpotent Drug

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Contact the company

Recalling firmAcella Pharmaceuticals, LLC1880 Mcfarland Pkwy Ste 110-B · Alpharetta, GA 30005

✎ GovInfoNow plain-language explainer

Acella Pharmaceuticals is recalling NP Thyroid 120 thyroid tablets (120 mg) because they contain less active drug than labeled. This could lead to inadequate thyroid hormone levels in users. The recall covers specific bottle sizes and production lots. Read more at govinfonow.com/recall/36162-acella-np-thyroid-120-tablets-recall-subpotent-drug-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36162-acella-np-thyroid-120-tablets-recall-subpotent-drug-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0399-2021

Cite this page

“Acella NP Thyroid 120 Tablets Recall: Subpotent Drug Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36162-acella-np-thyroid-120-tablets-recall-subpotent-drug-risk. Based on FDA recall #D-0399-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0399-2021%22&limit=1).

Acella Pharmaceuticals, LLC voluntarily recalled NP Thyroid 120 Thyroid Tablets on April 29, 2021, due to subpotent drug risks, the Food and Drug Administration said. The Class I recall affects specific lots distributed nationwide.

How to tell if you have it

Brand: Acella Pharmaceuticals
Product: NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg)
Packaging: 100-count bottles (NDC 42192-328-01) and 7-count bottles (NDC 42192-328-07)
Lot Codes: a) M328H19-2B, M328J19-11, M328J19-2A, M328J19-3A, M328J19-4A, M328J19-5A, M328J19-6A, M328J19-7A (Exp. 08/31/2021); b) M328K19-2, M328K19-4A (Exp. 09/30/2021); c) M328J19-9B (Exp. 08/31/2021)
Distribution: Nationwide within the United States including Puerto Rico

The hazard

The FDA classified the recall as Class I because the NP Thyroid tablets are subpotent, meaning they may not contain the labeled amount of active ingredient. The agency reported no specific incidents or injuries associated with this recall in the provided record.

Context

GovInfoNow's records show Acella Pharmaceuticals, LLC has 7 other recalls on record since May 22, 2020. Other recent recalls of similar products include Acella Naproxen Suspension Recall (April 20, 2026), Acella Doxycycline Tablets Recall (Sept. 29, 2025), and Acella Pharmaceuticals recalls Sodium Sulfacetamide Cleanser due to subpotent drug (April 24, 2024). Other recent recalls of similar products include Major Pharmaceuticals Levothyroxine Tablets Recall (July 13, 2026) and Accord Healthcare Levothyroxine Tablets Recall (Aug. 6, 2026).

How to tell if you have this one

Check for 100-count bottles (NDC 42192-328-01) or 7-count bottles (NDC 42192-328-07) with specific lot numbers listed in the recall. The tablets expire by August 2021 for most lots.

Brand
Acella Pharmaceuticals
Category
Drug

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
Distribution
Nationwide within the United States including Puerto Rico

Recall number	Product, codes & lots	Quantity	NDC
D-0395-2021	NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005; Lots: a) M327D20-1, M327D20-3 Exp. 03/31/2022, M327H19-3A Exp. 07/31/2021, M327L19-1 Exp. 04/30/2021; b) M327D20-1 Exp. 03/31/2022	a) 66,155 bottles; b) 26,212 bottles	42192-327-01, 42192-327-30, 42192-327-90, 42192-329-01, 42192-329-30, 42192-329-10, 42192-329-90, 42192-330-01, 42192-330-30, 42192-330-10, 42192-330-90, 42192-331-01, 42192-331-30, 42192-331-10, 42192-331-90, 42192-328-01, 42192-328-30, 42192-328-90, 42192-327-07
D-0396-2021	NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count bottles (NDC 42192-329-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005; Lots: a) M329D20-1, M329D20-2, M329D20-3 Exp. 03/31/2022, ; b) M329D20-2 Exp. 03/31/2022	a) 113,019 bottles; b) 44,900 bottles	42192-327-01, 42192-327-30, 42192-327-90, 42192-329-01, 42192-329-30, 42192-329-10, 42192-329-90, 42192-330-01, 42192-330-30, 42192-330-10, 42192-330-90, 42192-331-01, 42192-331-30, 42192-331-10, 42192-331-90, 42192-328-01, 42192-328-30, 42192-328-90, 42192-329-07
D-0397-2021	NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-330-01; 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, M330K19-9 Exp. 09/30/2021	154,726 bottles	42192-327-01, 42192-327-30, 42192-327-90, 42192-329-01, 42192-329-30, 42192-329-10, 42192-329-90, 42192-330-01, 42192-330-30, 42192-330-10, 42192-330-90, 42192-331-01, 42192-331-30, 42192-331-10, 42192-331-90, 42192-328-01, 42192-328-30, 42192-328-90
D-0398-2021	NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-331-01; Lots: M331J19-10A, M331J19-11, M331J19-2A, M331J19-6A, Exp. 08/31/2021, M331K19-1, M331K19-2, M331K19-6, Exp. 09/30/2021	79,344 bottles	42192-327-01, 42192-327-30, 42192-327-90, 42192-329-01, 42192-329-30, 42192-329-10, 42192-329-90, 42192-330-01, 42192-330-30, 42192-330-10, 42192-330-90, 42192-331-01, 42192-331-30, 42192-331-10, 42192-331-90, 42192-328-01, 42192-328-30, 42192-328-90
D-0399-2021	NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192-328-07) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005; Lot #: a) M328H19-2B, M328J19-11, M328J19-2A, M328J19-3A, M328J19-4A M328J19-5A, M328J19-6A, M328J19-7A, Exp. 08/31/2021, M328K19-2, M328K19-4A, Exp. 09/30/2021; b) M328J19-9B Exp. 08/31/2021	a) 69,289 bottles; b) 9,076 bottles	42192-327-01, 42192-327-30, 42192-327-90, 42192-329-01, 42192-329-30, 42192-329-10, 42192-329-90, 42192-330-01, 42192-330-30, 42192-330-10, 42192-330-90, 42192-331-01, 42192-331-30, 42192-331-10, 42192-331-90, 42192-328-01, 42192-328-30, 42192-328-90, 42192-328-07

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify your bottle's NDC code and lot number to confirm if it's in the recalled list.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States including Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

Apr 29, 2021Firm started the recall
May 24, 2021FDA classified it Class I
Jun 2, 2021Published in FDA’s Enforcement Report
Mar 13, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/36162-acella-np-thyroid-120-tablets-recall-subpotent-drug-risk">Acella NP Thyroid 120 Tablets Recall: Subpotent Drug Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0399-2021 (April 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0399-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.