Skip to content
Get alerts
GovInfoNow
Lower risk Drug recall · FDA · Published April 10, 2025

Accord Healthcare recalls Levothyroxine tablets with subpotent risk

Accord Healthcare recalls 1000-bottle supply of Levothyroxine Sodium Tablets (88 mcg) due to subpotent levels. This may not provide adequate thyroid hormone. No remedy specified in recall notice.

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

🇺🇸 FDA recall #D-0396-2025DrugAccord Healthcare ›
Take action

Contact the company

Recalling firmACCORD HEALTHCARE, INC.8041 Arco Corporate Dr Ste 200 · Raleigh, NC 27617-2010
✎ GovInfoNow plain-language explainer

Accord Healthcare is recalling 1000 bottles of Levothyroxine Sodium Tablets (88 mc: 0.088 mg) because they may not contain enough active ingredient. This could lead to inadequate thyroid hormone levels in patients who need the medication. Read more at govinfonow.com/recall/32150-accord-healthcare-recalls-levothyroxine-tablets-with-subpotent-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32150-accord-healthcare-recalls-levothyroxine-tablets-with-subpotent-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0396-2025

Cite this page

“Accord Healthcare recalls Levothyroxine tablets with subpotent risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32150-accord-healthcare-recalls-levothyroxine-tablets-with-subpotent-risk. Based on FDA recall #D-0396-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0396-2025%22&limit=1).

The FDA announced on April 10, 2025, that Accord Healthcare is recalling Levothyroxine Sodium Tablets, USP, 88 mcg due to subpotency risks. The agency issued recall number D-0396-2025 for the voluntary Class II action affecting 4,885 bottles distributed nationwide.

How to tell if you have it

  • Brand: Accord Healthcare
  • Product: Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg)
  • NDC: 16729-450-17
  • Lot #: D2300044
  • Expiration Date: 12/2025
  • Quantity: 1,000 bottles per unit (4,885 total bottles affected)
  • Distribution: Nationwide US

The hazard

The recall is due to the product being subpotent. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Accord Healthcare has 16 other recalls on record since December 20, 2016. Other recent recalls of similar products include Major Pharmaceuticals Levothyroxine Tablets Recall (July 13, 2026), Macleods Levothyroxine Tablets Recall (February 26, 2026), and Specialty Process Labs Thyroid Product Recall (January 16, 2026).

How to tell if you have this one

Check for the product name 'Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg)' on the label. The recall covers 1000 bottles manufactured with lot number D2300044 and expiration date 12/2025.

  • Brand
    Accord Healthcare
  • Category
    Drug
FDA recall event · 4 products

All 4 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 II
  • Status
    Ongoing
  • Distribution
    Nationwide US.
  • NDC
    16729-458-15, 16729-458-17, 16729-447-15, 16729-447-17, 16729-448-15, 16729-448-17, 16729-449-15, 16729-449-17, 16729-451-15, 16729-451-17, 16729-450-15, 16729-450-17, 16729-452-15, 16729-452-17, 16729-453-15, 16729-453-17, 16729-454-15, 16729-454-17, 16729-455-15, 16729-455-17, 16729-456-15, 16729-456-17, 16729-457-15, 16729-457-17
Recall numberProduct, codes & lotsQuantity
D-0394-2025Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17; Lot # D2300323, Exp Date: 01/20264,888 Bottles
D-0395-2025Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17.; Lot # D2400547, Exp Date: 02/20264,872 Bottles
D-0396-2025Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17; Lot # D2300044, Exp Date: 12/20254,885 Bottles
D-0397-2025Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15; Lot # D2400725, Exp Date: 03/202618,984 Bottles
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the product name 'Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg)' and the lot number D2300044.

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 US.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 27 days after the firm started it.

1. Firm started the recall: Apr 10, 202512. FDA classified it Class II: Apr 30, 202523. Published in FDA’s Enforcement Report: May 7, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

Similar recalls

Accord Healthcare recalls Levothyroxine tablets with subpotent drug risk
Accord HealthcareAccord Healthcare Levothyroxine Tablets Recall: Subpotent Drug Risk
Accord HealthcareMacleods Levothyroxine Tablets Recall: Subpotent Drug Risk
Macleods PharmaMajor Pharmaceuticals Levothyroxine Tablets Recall: Subpotent Drug Risk
Major PharmaceuticalsAmerican Health Packaging Recalls Metoclopramide Tablets Due to Foreign Drug Presence
American Health Packaging

Latest drug recalls

Teva Pharmaceuticals USA, Inc recalls Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals,
Teva Pharmaceuticals · September 29, 2026Preferred Pharmaceuticals, Inc. recalls Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A.,
Preferred Pharmaceuticals · September 28, 2026SUN PHARMACEUTICAL INDUSTRIES INC recalls Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro
Northstar Rx · September 25, 2026Apothecary Pharma LLC recalls Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary,
Apothecary Pharma · September 24, 2026Apotex Corp. recalls Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario,
Apotex · September 23, 2026Cipla USA, Inc. recalls Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx
Cipla USA · September 18, 2026

Keep exploring

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-0396-2025 (April 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0396-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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