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Class II · ModerateActive recall

Levothyroxine Sodium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # D2300045, Exp 12/31/2025.
Where it was soldNationwide in the US
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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 to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byIntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India foreign manufacturer
Brand nameLEVOTHYROXINE SODIUM
Generic nameLEVOTHYROXINE SODIUM
Active ingredient(s)LEVOTHYROXINE SODIUM
Distributed by / forAccord Healthcare, Inc., Raleigh, NC 27617
NDC16729-450-15
Show the full FDA record
Full product labelLevothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.
Recalling firmACCORD HEALTHCARE, INC.
DistributionNationwide in the US
Quantity54,432 bottles
Recall initiated2025-09-16
Report date2025-10-15
Recall completed—
Recall numberD-0006-2026
ClassificationClass II
FDA statusOngoing
Origin on fileRaleigh NC United States

Related

Levothyroxine recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.