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Lower risk Drug recall · FDA · Published September 17, 2020

Acella NP Thyroid 15 Tablets Recall: Subpotent Levothyroxine Risk

Acella Pharmaceuticals recalls 100-count NP Thyroid 15 tablets (15 mg) due to subpotent levothyroxine content. FDA analysis shows these products contain less active ingredient than labeled, potentially causing inadequate thyroid hormone levels.

🇺🇸 FDA recall #D-0035-2021DrugAcella ›
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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 100-count NP Thyroid 15 tablets (15 mg) because FDA testing found they contain less levothyroxine than labeled. This could lead to insufficient thyroid hormone levels in patients taking the medication. Read more at govinfonow.com/recall/36769-acella-np-thyroid-15-tablets-recall-subpotent-levothyroxine-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36769-acella-np-thyroid-15-tablets-recall-subpotent-levothyroxine-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0035-2021

Cite this page

“Acella NP Thyroid 15 Tablets Recall: Subpotent Levothyroxine Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36769-acella-np-thyroid-15-tablets-recall-subpotent-levothyroxine-risk. Based on FDA recall #D-0035-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0035-2021%22&limit=1).

The FDA announced on September 17, 2020, that Acella Pharmaceuticals voluntarily recalled NP Thyroid 15 tablets due to subpotent drug risks. The agency found the levothyroxine content was less than labeled claims.

How to tell if you have it

  • Brand: Acella
  • Product: NP Thyroid 15, Thyroid Tablets, USP 1/4 grain (15 mg)
  • Packaging: 100-count bottles
  • NDC: 42192-327-01
  • Lot #: M327E19-1
  • Expiration Date: 10/2020

The hazard

FDA analysis found the products to be less than the labeled claim for the levothyroxine (T4) portion of the product. The recall is classified as Class I.

Context

GovInfoNow's records show Acella Pharmaceuticals has had seven other recalls since May 22, 2020. Recent brand recalls include a lead and lithium contamination risk in Naproxen Suspension on April 20, 2026, and failed dissolution testing in Doxycycline Tablets on September 29, 2025. Other recent recalls of similar products include Major Pharmaceuticals Levothyroxine Tablets Recall (July 13, 2026), Accord Healthcare Levothyroxine Tablets Recall (August 6, 2026), and Macleods Levothyroxine Tablets Recall (February 26, 2026).

How to tell if you have this one

Check for 100-count NP Thyroid 15 tablets (15 mg) with NDC 42192-327-01, manufactured in Alpharetta, GA, lot M327E19-1, expiring 10/2020. The product is prescription-only.

  • Brand
    Acella
  • Category
    Drug
FDA recall event · 2 products

All 2 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
  • NDC
    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
Recall numberProduct, codes & lotsQuantity
D-0035-2021NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01; Lot #: M327E19-1 Exp. 10/202019,296 bottles
D-0036-2021NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01; Lot #: M328F19-3 Exp. 11/20209816 bottles
Based on the official FDA remedy

What to do — step by step

  1. Check Medication Details

    Verify if your medication matches the recalled product description: 100-count NP Thyroid 15 tablets (15 mg), NDC 42192-327-01, lot M327E19-1, expiring 10/2020.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

1. Firm started the recall: Sep 17, 202012. FDA classified it Class I: Oct 19, 202023. Published in FDA’s Enforcement Report: Oct 28, 202034. FDA terminated the recall: Dec 8, 2022420202022
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall record indicates the product may not provide enough thyroid hormone, so it's not recommended for use as intended without consulting a healthcare provider.

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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-0035-2021 (September 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0035-2021 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA