Levoxyl 50 microgram levothyroxine tablets recalled as a subpotent drug
Levoxyl (levothyroxine sodium tablets, USP) 50 mcg from Pfizer is being recalled because the product is subpotent. 29,004 bottles are affected.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: a subpotent thyroid hormone tablet may under-treat the condition it is prescribed for, with no injury reported in the source.
Plain-English summary
Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottles, prescription only, distributed by Pfizer Inc. of New York and made in Austria, NDC 60793-851-01, is being recalled. The action covers 29,004 bottles.
The stated reason is a subpotent drug. The FDA classified the action as Class II.
The affected lot is 24C11, expiring 2/28/2026. Distribution was within the US.
Patients holding the affected lot should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by Pfizer.
The recalled product
- Product
- LEVOXYL (LEVOTHYROXINE SODIUM)
- Brand
- LEVOXYL
- Manufacturer
- Pfizer
- Category
- Drug — Oral tablet
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 #: 24C11
- Exp 2/28/2026.
UPCs (11)
- 0360793856018
- 0360793850016
- 0360793852010
- 0360793851013
- 0360793857015
- 0360793853017
- 0360793854014
- 0360793858012
- 0360793855011
- 0360793859019
- 0360793860015
Distribution
Distribution scope not specified by the agency.
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