Class III
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.
Presence of a foreign substance: black hair found embedded in tablet.
- Recall number
- D-0470-2025
- Report date
- June 18, 2025
- Classification
- Class III
- Status in dataset
- Ongoing
- Recalling firm
- Macleods Pharmaceuticals Ltd
- Generic names
- LEVOTHYROXINE SODIUM
- Brand names
- LEVOTHYROXINE SODIUM
- Product NDCs
- 33342-393, 33342-394, 33342-395, 33342-396, 33342-397, 33342-398, 33342-399, 33342-400, 33342-401, 33342-402, 33342-403, 33342-404
Code and lot information
Lot #: MLF2401A, Exp 01/31/2026
Distribution
Nationwide in the USA
Do not stop or change a prescribed medication based only on this page.Contact your pharmacist or prescriber and compare the exact product, manufacturer, NDC, and lot information.
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.