HIGH

Accord Healthcare Recalls Levothyroxine Sodium Tablets Over Potency Issues

Accord Healthcare recalled 54,432 bottles of Levothyroxine Sodium Tablets on September 16, 2025. The tablets were found to be subpotent during stability testing. Consumers should stop using the product immediately and seek guidance from healthcare providers.

Quick Facts at a Glance

Recall Date
September 16, 2025
Hazard Level
HIGH
Brands
Levothyroxine Sodium, Accord Healthcare
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact ACCORD HEALTHCARE, INC. or your healthcare provider for guidance. Notification method: Letter

Product Details

The recall involves Levothyroxine Sodium Tablets, USP, 88 mcg, packaged in bottles of 90 tablets. The affected lot number is D2300045, with an expiration date of December 31, 2025. These products were distributed nationwide.

The Hazard

The tablets were tested and found to have assay content below the approved specification range. This subpotency can lead to inadequate treatment for patients requiring thyroid hormone replacement.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. However, the risk of inadequate treatment remains a serious concern.

What to Do

Stop using the recalled Levothyroxine Sodium Tablets immediately. Contact Accord Healthcare or your healthcare provider for further guidance and potential arrangements for return and refund.

Contact Information

For more information, contact Accord Healthcare at 1-800-XXXX-XXXX or visit their website at www.accordhealthcare.com.

Key Facts

  • Recalled product: Levothyroxine Sodium Tablets, USP, 88 mcg
  • Total recalled: 54,432 bottles
  • Recall date: September 16, 2025
  • Hazard: Subpotent tablets
  • Action: Stop use immediately
View Original Recall on FDA - Drug Safety

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeLevothyroxine Sodium Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
Lot # D2300045
Exp 12/31/2025
UPC Codes
16729-447
16729-458
16729-448
+17 more
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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