FDA Recall D-0575-2025
Pfizer · Manhattan, NY
Class II Ongoing 289 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
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.
Reason for recall
Subpotent drug
Recall record
- Recall number
D-0575-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Within U.S
- Recall initiated
- 2025-07-29
- Classified by FDA Center
- 2025-08-08
- FDA published
- 2025-08-20
- Recalling firm
- Pfizer
- Firm location
- Manhattan, NY
Drug identification
- Brand name(s)
- LEVOXYL
- Generic name(s)
- LEVOTHYROXINE SODIUM
- Manufacturer(s)
- Pfizer Laboratories Div Pfizer Inc
- NDC(s)
60793-850, 60793-851, 60793-852, 60793-853, 60793-854, 60793-855, 60793-856, 60793-857, 60793-858, 60793-859, 60793-860- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.