Could cause temporary or reversible harm; serious harm is unlikely.
Subpotent Drug: confirmed out-of-specification (OOS) assay during stability testing.
| Brand name | LEVOXYL |
| Generic name | LEVOTHYROXINE SODIUM |
| Active ingredient(s) | LEVOTHYROXINE SODIUM |
| Distributed by / for | Pfizer Inc., New York, NY 10017 |
| NDC | 60793-859-01 |
| Full product label | Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg, 100 tablet bottle, Rx only, Distributed by Pfizer Inc., New York, NY 10017, Made in Austria. NDC 60793-859-01. |
| Recalling firm | Pfizer |
| Distribution | US Nationwide and Puerto Rico |
| Quantity | 15,815 100-count bottles |
| Recall initiated | 2026-09-29 |
| Report date | 2026-10-28 |
| Recall completed | — |
| Recall number | D-0052-2027 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Manhattan NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗