Class II
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-15
Subpotent Drug: Assay below the approved specification
- Recall number
- D-0518-2025
- Report date
- July 23, 2025
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Generic names
- LEVOTHYROXINE SODIUM
- Brand names
- LEVOTHYROXINE SODIUM
- Product NDCs
- 16729-447, 16729-458, 16729-448, 16729-449, 16729-451, 16729-450, 16729-452, 16729-453, 16729-454, 16729-455, 16729-456, 16729-457
Code and lot information
Lot #D2300325, Exp Date: 01/31/2026; Lot #D2400536, Exp Date: 02/28/2026
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.