Recalls / Class II
Class IID-0575-2025
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.
- Brand name
- Levoxyl
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 60793-850, 60793-851, 60793-852, 60793-853, 60793-854, 60793-855, 60793-856, 60793-857, 60793-858, 60793-859 +1 more
- FDA application
- NDA021301
- Affected lot / code info
- Lot #: 24C11, Exp 2/28/2026.
Why it was recalled
Subpotent drug
Recalling firm
- Firm
- Pfizer
- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 66 Hudson Blvd, N/A, Manhattan, New York 10001
Distribution
- Quantity
- 29, 004 bottles
- Distribution pattern
- Within U.S
Timeline
- Recall initiated
- 2025-07-29
- FDA classified
- 2025-08-08
- Posted by FDA
- 2025-08-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0575-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.