Why it was recalled
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
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.
Lot numbers, UPCs & expiration codes
Lot # 12250247B, Exp. 01/31/2027
Where it was sold
U.S. Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0509-2025
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 11, 2025
- FDA report date
- Jul 16, 2025
- Quantity
- 9,888/ 30 count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharmaceuticals Ltd
Original FDA data
Every field from FDA enforcement report D-0509-2025, exactly as published.
Show all FDA fields
- City
- Mumbai
- Status
- Ongoing
- Country
- India
- Event ID
- 97058
- Address
- 304 Atlanta Arcade
- Address (line 2)
- Church Road
- Code information
- Lot # 12250247B, Exp. 01/31/2027
- Report date
- Jul 16, 2025
- Product type
- Drugs
- Recall number
- D-0509-2025
- Classification
- Class III
- Recalling firm
- Macleods Pharmaceuticals Ltd
- Product quantity
- 9,888/ 30 count bottles
- Reason for recall
- Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- U.S. Nationwide.
- Recall initiation date
- Jun 11, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 7, 2025