Class II · Moderate risk
Famciclovir Tablets
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
Famciclovir Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
33342-0026-07
Compare with the code on your package — it is the most precise check available.
Drug: Famciclovir
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Famciclovir NDC 33342-0026 |
500 mg/1 | Tablet, Film Coated Oral |
Macleods Pharmaceuticals Limited | Rx |
- Recalling firm
- Macleods Pharmaceuticals Ltd
- NDC code
- 33342-026-07
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0509-2025 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Famciclovir recalls
See all
Class II · Moderate risk
Famciclovir tablets
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
Class II · Moderate risk
Famciclovir active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Famciclovir
Labeling: Label Mixup: FAMCICLOVIR, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: TOLTERODINE TARTRATE ER, Capsule, 4 mg, NDC 00009519101, Pedigree: AD49448_1, EXP: 5/17/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD54559_1, EXP: 5/20/2014.
Other recalls by Macleods Pharmaceuticals Ltd
All 2025 recalls
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Class III · Low risk
Levothyroxine Sodium Tablets
Presence of a foreign substance: black hair found embedded in tablet.
Class II · Moderate risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications
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