FDA Drugs recall ·
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles… recall
- Recall number
- D-0394-2025
- Date
- (initiated April 10, 2025)
- Company / brand
- Accord Healthcare, Inc.
8041 Arco Corporate Dr Ste 200, Raleigh, NC, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4,888 Bottles
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17
Why was it recalled?
Subpotent
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 # D2300323, Exp Date: 01/2026
Distribution
Nationwide US.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0394-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.