Drug Recall Enforcement Report Class III voluntary initiated by Macleods Pharmaceuticals Ltd, originally initiated on 06-11-2025 for the 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. The product was recalled due to presence of foreign substance- black hair strand found attached to a tablet in a sealed bottle.. The product was distributed nationwide and the recall is currently ongoing.
| Field Name |
Field Value |
| Event ID |
97058 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number |
D-0509-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification |
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern |
U.S. Nationwide. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| Product Description |
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 For Recall |
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. What is the Reason for Recall?
Information describing how the product is defective. |
| Product Quantity |
9,888/ 30 count bottles Product Quantity
The amount of product subject to recall. |
| Voluntary Mandated |
Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date |
07-16-2025 |
| Recall Initiation Date |
06-11-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. |
| Initial Firm Notification |
Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type |
Drugs |
| Recalling Firm |
Macleods Pharmaceuticals Ltd |
| Code Info |
Lot # 12250247B, Exp. 01/31/2027 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages |
33342-024-07; 33342-025-07; 33342-026-07 |
| Status |
Ongoing |
Recalled Products
