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Class II · ModerateRecall completed

Levothyroxine Sodium

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

Does this affect you?
Check your lot numberLot # HE02221, Exp. 05/2023
Where it was soldNationwide and Puerto Rico.
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

Sub-Potent Drug: Out of specification for assay at the 24 month interval.

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 byLloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058
Brand nameLEVOTHYROXINE SODIUM
Generic nameLEVOTHYROXINE SODIUM
Active ingredient(s)LEVOTHYROXINE SODIUM
Distributed by / forAlvogen Inc, Pine Brook, NJ 07058
NDC47781-654-90
Show the full FDA record
Full product labelLevothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.
Recalling firmAlvogen, Inc
DistributionNationwide and Puerto Rico.
Quantity21,276 bottles
Recall initiated2023-02-06
Report date2023-03-08
Recall completed2024-03-18
Recall numberD-0353-2023
ClassificationClass II
FDA statusTerminated
Origin on fileMorristown NJ United States

Related

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.