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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Levothyroxine Sodium, Accord Healthcare
- Product type
- Levothyroxine Sodium Tablets, 88 mcg
- Model numbers
- Lot # D2300045, Exp 12/31/2025
- UPC codes
- 16729-447, 16729-458, 16729-448, 16729-449, 16729-451, 16729-450, 16729-452, 16729-453 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 16, 2025
Reported by FDA DRUG
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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.
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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
- Hazard: Subpotent potency detected during stability testing
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Safety Guide
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