Medications & Supplements/Prescription Drugs

Famciclovir Tablets Recalled for Foreign Substance Contamination

Agency Publication Date: July 7, 2025

Summary

Macleods Pharmaceuticals Ltd is recalling 9,888 bottles of Famciclovir (500 mg) tablets. This recall was initiated after a consumer discovered a black hair strand attached to a tablet inside a sealed bottle. Famciclovir is a prescription antiviral medication used to treat viral infections like shingles and herpes.

Risk

The presence of a foreign substance such as a hair strand in a medication bottle poses a risk of contamination and could potentially cause a choking hazard or irritation if ingested.

What You Should Do

This recall affects 30-count bottles of Famciclovir Tablets, USP 500 mg, with NDC number 33342-026-07.
Identify the affected product by looking for lot number 12250247B with an expiration date of 01/31/2027 printed on the label.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Macleods Pharmaceuticals Ltd for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Famciclovir Tablets, USP 500 mg (30-count)

Variants: 500 mg, Tablet

Lot Numbers:

12250247B (Exp. 01/31/2027)

NDC:

33342-026-07

Manufactured for Macleods Pharma USA, Inc. by Macleods Pharmaceuticals Ltd.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97058

Status: Active

Manufacturer: Macleods Pharmaceuticals Ltd

Sold By: pharmacies

Manufactured In: India

Units Affected: 9,888/ 30 count bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 30-count bottles of Famciclovir Tablets, USP 500 mg, with NDC number 33342-026-07.

Identify the affected product by looking for lot number 12250247B with an expiration date of 01/31/2027 printed on the label.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Macleods Pharmaceuticals Ltd for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.