Drug recall
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord…
FDA recall event 97613 · Class II · ACCORD HEALTHCARE, INC.
Key facts
| Event ID | 97613 |
|---|---|
| Recall numbers | D-0006-2026 |
| Recalling firm | ACCORD HEALTHCARE, INC. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range. |
| Initiation date | Sep 16, 2025 |
| Report date | Oct 15, 2025 |
| City | Raleigh |
| State | NC |
| Country | United States |
| FEI number | 3029363826 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: