Famciclovir Tablets Recalled for Foreign Substance Contamination
Macleods Pharmaceuticals is recalling Famciclovir 500 mg tablets nationwide due to a black hair strand found in a sealed bottle. No illnesses have been reported.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving foreign substance contamination with no reported illnesses or injuries. Class III recalls are typically scored 1 or 2; physical contamination warrants a Moderate (2) rather than Low (1) score.
Plain-English summary
Macleods Pharmaceuticals Ltd is recalling Famciclovir Tablets, USP 500 mg in 30-count bottles distributed nationwide across the U.S. The recalled lot is #12250247B, expiring January 31, 2027, affecting approximately 9,888 bottles.
The recall is due to the presence of a foreign substance—a black hair strand found attached to a tablet in a sealed bottle. No illnesses or injuries have been reported in connection with this recall.
Consumers should verify the lot number (#12250247B) and expiration date on their bottles to determine if they have the affected product. Those with affected bottles should contact their healthcare provider or pharmacist.
The recalled product
- Product
- FAMCICLOVIR (FAMCICLOVIR)
- Brand
- FAMCICLOVIR
- Manufacturer
- Macleods Pharmaceuticals Ltd
- Category
- Drug — Prescription Antiviral
- Hazard
- foreign-object
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 12250247B
- Exp. 01/31/2027
UPCs (3)
- 0333342026071
- 0333342024077
- 0333342025074
Distribution
Distributed nationwide across the United States.
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