Famciclovir Tablets recall
FDA recall D-0509-2025 · initiated Jun 11, 2025
Macleods Pharmaceuticals Ltd recalled Famciclovir Tablets in Jun 2025 — an FDA Class III recall (D-0509-2025) because Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 9,888/ 30 count bottles
Details
- 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.
- Recalling company
- Macleods Pharms Ltd
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide.
- Initiated
- Jun 11, 2025
- FDA report date
- Jul 16, 2025
Frequently asked
- Was Famciclovir Tablets recalled?
- Macleods Pharmaceuticals Ltd recalled Famciclovir Tablets in Jun 2025 — an FDA Class III recall (D-0509-2025) because Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Famciclovir Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0509-2025 was: Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
- Is a recalled Famciclovir Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Famciclovir Tablets are affected?
- Distributed: U.S. Nationwide.. The recall covers these lots — Lot # 12250247B, Exp. 01/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0509-2025.