Recalls / Class II
Class IID-0119-2025
Product
Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Brand name
- Levothyroxine Sodium
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 0378-1800, 0378-1803, 0378-1805, 0378-1807, 0378-1809, 0378-1811, 0378-1813, 0378-1823, 0378-1815, 0378-1817 +2 more
- FDA application
- ANDA076187
- Affected lot / code info
- Lot #: a) 8165919, Exp. Date Dec 2024; 8172050, Exp. Date Mar 2025; 8183251, Exp. Date Sept 2025 b) 3185542, Exp. date Dec 2024; 3192838, Exp. Date Mar 2025; 3208172, Exp. Date Sept 2025
Why it was recalled
Superpotent Drug and Subpotent Drug: potency failures obtained
Recalling firm
- Firm
- Viatris Inc
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1000 Mylan Blvd, Canonsburg, Pennsylvania 15317-5853
Distribution
- Quantity
- 118,324 bottles
- Distribution pattern
- Nationwide within the United States and Puerto Rico
Timeline
- Recall initiated
- 2024-11-18
- FDA classified
- 2024-12-12
- Posted by FDA
- 2024-12-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0119-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.