The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0339-2019·Announced 2018-12-26

Pfizer Recalls Levoxyl Levothyroxine Sodium Tablets Due to Superpotency

Pfizer is voluntarily recalling 1,996 bottles of Levoxyl 112 mcg tablets nationwide because the drug is superpotent.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant hazard (superpotency of a prescription drug) without explicit reports of hospitalization or death maps to a score of 4 (Severe), as it is not Class I (Critical) but represents a serious potential for harm.

Plain-English summary

Pfizer Inc. is voluntarily recalling 1,996 bottles of Levoxyl (levothyroxine sodium tablets, USP) 112 mcg, 100-count bottles. The affected product is identified by Lot #18A18 with an expiration date of 01/2020 and NDC 60793-855-01. The recall was initiated on December 6, 2018, and the product was distributed nationwide within the United States.

The reason for the recall is that the drug is classified as "Superpotent." This means the tablets contain more active ingredient than the labeled amount, which can lead to adverse health effects in patients taking the medication. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have this specific lot of Levoxyl should stop using it and contact their healthcare provider or pharmacist for guidance. The recall status is currently terminated, having been closed on October 8, 2020.

The recalled product

Product
LEVOXYL (LEVOTHYROXINE SODIUM)
Brand
LEVOXYL
Manufacturer
Pfizer Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
1,996

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 (2)

  • Lot #:18A18
  • Exp. 01/2020

UPCs (11)

  • 0360793856018
  • 0360793850016
  • 0360793852010
  • 0360793851013
  • 0360793857015
  • 0360793853017
  • 0360793854014
  • 0360793858012
  • 0360793855011
  • 0360793859019
  • 0360793860015

Distribution

Distributed nationwide across the United States.

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