Drug recall
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc…
FDA recall event 97058 · Class III · Macleods Pharmaceuticals Ltd
Key facts
| Event ID | 97058 |
|---|---|
| Recall numbers | D-0509-2025 |
| Recalling firm | Macleods Pharmaceuticals Ltd |
| Product type | Drugs |
| Products | Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07. |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. |
| Initiation date | Jun 11, 2025 |
| Report date | Jul 16, 2025 |
| City | Mumbai |
| Country | India |
| FEI number | 3007013286 |
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: