FDA Drugs recall ·
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets… recall
- Recall number
- D-0470-2025
- Date
- (initiated May 29, 2025)
- Company / brand
- Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Mumbai, India - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 1,344- 1000 count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Presence of a foreign substance: black hair found embedded in tablet.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: MLF2401A, Exp 01/31/2026
Distribution
Nationwide in the USA
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0470-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.