FDA recall, , Moderate risk
Accord Healthcare Levothyroxine Sodium Tablets
Levothyroxine Sodium Tablets are subpotent.
Summary by Recall Canary from the FDA notice
What happened
Accord Healthcare, Inc. of Raleigh, North Carolina is recalling Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, because the drug is subpotent. The product was manufactured by lntas Pharmaceuticals Limited in India and distributed nationwide. The recall began June 8, 2026, and was added to the FDA's Enforcement Report on June 30, 2026.
Accord Healthcare initiated the recall of 6432 bottles after the FDA classified it on June 30, 2026. The recall was included in the FDA's weekly enforcement report on July 8, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles
- NDC
- 16729-458-15
- Lot code
- 2026
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- ACCORD HEALTHCARE, INC.Raleigh, North Carolina
- Hazard
- Wrong drug strength
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99194
- Recall number
- D-0656-2026
- Quantity recalled
- 6432 bottles
All recalls from ACCORD HEALTHCARE, INC.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
