Recalls / Class III
Class IIID-0470-2025
Product
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.
- Brand name
- Levothyroxine Sodium
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 33342-393, 33342-394, 33342-395, 33342-396, 33342-397, 33342-398, 33342-399, 33342-400, 33342-401, 33342-402 +2 more
- FDA application
- ANDA211417
- Affected lot / code info
- Lot #: MLF2401A, Exp 01/31/2026
Why it was recalled
Presence of a foreign substance: black hair found embedded in tablet.
Recalling firm
- Firm
- Macleods Pharmaceuticals Ltd
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 304 Atlanta Arcade, Church Road, Mumbai, N/A, India
Distribution
- Quantity
- 1,344- 1000 count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-05-29
- FDA classified
- 2025-06-12
- Posted by FDA
- 2025-06-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0470-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.