The Recall Desk
ModerateFDA (Drugs)·D-107-2013·Announced 2013-01-09

Abbott Recalls Synthroid Tablets Due to Incorrect Strength Labeling

Abbott Laboratories is recalling specific lots of Synthroid (levothyroxine sodium) tablets because bottles labeled as 150 mcg actually contained 75 mcg tablets.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves situations where use may cause temporary or medically reversible health consequences. The hazard is a labeling error resulting in incorrect dosage, which fits the criteria for moderate severity without reported injuries or fatalities.

Plain-English summary

Abbott Laboratories is voluntarily recalling 28,524 bottles of Synthroid (levothyroxine sodium) tablets. The recall involves 150 mcg (0.15 mg) tablets, 90 tablets per bottle, with NDC 0074-7069-90. The specific lot number is 18262A8, and the expiration date is 09/13.

The recall was initiated due to a labeling error regarding the declared strength. The product was labeled to contain 150 mcg tablets, but the bottles actually contained 75 mcg tablets. This discrepancy means patients may have received a lower dose of medication than prescribed.

The affected product was distributed nationwide in the United States and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recall description, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

Product
SYNTHROID (LEVOTHYROXINE SODIUM)
Brand
SYNTHROID

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • LOT # 18262A8 Exp. 09/13

UPCs (10)

  • 0300747149902
  • 0300747068197
  • 0300744341194
  • 0300745182192
  • 0300747070190
  • 0300747069903
  • 0300749296192
  • 0300743727906
  • 0300747148905
  • 0300746624905

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: