Drug FDA Class II Ongoing Sub/super-potent

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.

Pfizer Published Aug 20, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 50/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Pfizer or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Subpotent drug

Hazards

Subpotency · primary

Affected products (1)

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.

LEVOXYL · 29, 004 bottles

NDC: 60793-850, 60793-851, 60793-852, 60793-853, 60793-854, 60793-855, 60793-856, 60793-857, 60793-858, 60793-859, 60793-860, 60793-850-10, 60793-850-01, 60793-851-10, 60793-851-01, 60793-852-10, 60793-852-01, 60793-853-10, 60793-853-01, 60793-854-10, 60793-854-01, 60793-855-10, 60793-855-01, 60793-856-10, 60793-856-01, 60793-857-10, 60793-857-01, 60793-858-10, 60793-858-01, 60793-859-10, 60793-859-01, 60793-860-10, 60793-860-01

Code info: Lot #: 24C11, Exp 2/28/2026.

Affected areas

Within U.S

Timeline

Initiated

Jul 29, 2025
Published

Aug 20, 2025

Recall number: D-0575-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.