FDA Drugs recall ·
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg)… recall
- Recall number
- D-0006-2026
- Date
- (initiated September 16, 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
- 54,432 bottles
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.
Why was it recalled?
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
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 # D2300045, Exp 12/31/2025.
Distribution
Nationwide in the 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-0006-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.