Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, N
Summary
The FDA issued a Class II for Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, by Pfizer. Reason: Subpotent drug.
Details
Source
Drug Recall
External ID
D-0575-2025
Action Date
2025-08-20
Status
Ongoing
Category
drug
Product Description
Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Austria, NDC 60793-851-01.
Lot/Code Info: Lot #: 24C11, Exp 2/28/2026.
Quantity Affected: 29, 004 bottles
Reason for Recall
Subpotent drug
Distribution
Within U.S
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-29
Company
Manhattan, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pfizer has 28 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pfizer) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pfizer have FDA actions?
Pfizer has 28 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0575-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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