HIGH

Accord Healthcare Recalls 54,432 Levothyroxine 88 mcg Tablets for Subpotent Potency (2025)

Accord Healthcare recalled 54,432 bottles of Levothyroxine Sodium Tablets, USP, 88 mcg, distributed nationwide in the United States. The recall is due to subpotent assay content observed during long-term stability testing. Patients should stop using the product immediately and contact Accord Healthcare or their healthcare provider for guidance.

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

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About This Product

Levothyroxine is a prescription thyroid hormone replacement. It is used to treat hypothyroidism and certain thyroid conditions. This recall covers a specific 88 mcg dose bottle sold nationwide in the U.S.

Why This Is Dangerous

Subpotent potency means the tablet contains less active ingredient than labeled, which may fail to adequately treat hypothyroidism over time.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients could experience persistent hypothyroid symptoms if under-dosed. Providers may need to adjust therapy and monitor thyroid function after replacement.

Practical Guidance

How to identify if yours is affected

  1. Check bottle label for NDC 16729-450-15.
  2. Verify Lot # D2300045 and Exp 12/31/2025.
  3. Confirm bottle contains 90 tablets per bottle and 88 mcg dosage.

Where to find product info

Drug packaging and bottle label show NDC, Lot, and Exp dates.

What timeline to expect

Refund or replacement typically takes 4-8 weeks after receipt of notice and return materials.

If the manufacturer is unresponsive

  • Document all communications with the manufacturer.
  • File a complaint with the FDA if you encounter delays.

How to prevent similar issues

  • When replacing, verify the lot and expiration on the new bottle.
  • Ask your pharmacist to confirm drug potency and source before filling a prescription.
  • Maintain ongoing medical supervision for thyroid therapy adjustments.

Documentation advice

Keep copies of recall notices, bottle labels, lot numbers, expiration dates, and all correspondence with the manufacturer and healthcare providers.

Product Details

Model numbers: Lot # D2300045; Exp 12/31/2025. NDC 16729-450-15. Sold nationwide in the U.S. through pharmacies and healthcare providers. Sold since: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 54,432 bottles recalled nationwide in the U.S.
  • Product: Levothyroxine Sodium Tablets, USP, 88 mcg, 90 tablets per bottle
  • Lot: D2300045; Exp: 12/31/2025; NDC: 16729-450-15
  • Hazard: Subpotent potency detected during stability testing

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

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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