FDA Drug recall D-0509-2025
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmace…
- FDA Drug
- Class III
- ongoing
- Published 2025-07-16
On 2025-07-16 the FDA classified a Class III recall of Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmace… by Macleods Pharmaceuticals, citing presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0509-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-06-11 |
| Published | 2025-07-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Macleods Pharmaceuticals |
| Distribution | US |
Product
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.
Reason
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Identifiers
| ndc | 33342-024-07 |
|---|---|
| ndc | 33342-025-07 |
| ndc | 33342-026-07 |
| code_info | Lot # 12250247B, Exp. 01/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0509-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.