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.
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
- Check bottle label for NDC 16729-450-15.
- Verify Lot # D2300045 and Exp 12/31/2025.
- 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.