Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Famciclovir recalled?

Yes — there is an active recall. 1 ongoing FDA recall mention Famciclovir (5 total). Check the affected lots below.

Most common reason: Cross-contamination (1 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Famciclovir. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Famciclovir recalls on record

none so far in 2026; 5 on record, newest first
Class III · Low risk

Famciclovir Tablets

Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.

Ongoing Particulate / foreign matter Macleods Pharmaceuticals Ltd NDC 33342-026-07 D-0509-2025
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.

Terminated Temperature excursion Hetero Labs Limited Unit V NDC 31722-708-30 D-0415-2018
Class II · Moderate risk

Famciclovir tablets

Failed impurities/ degradation specifications: Product was above specification for unknown impurities.

Terminated Impurity / degradation AVKARE Inc. NDC 50268-307-13 D-0610-2017
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.

Terminated Cross-contamination Attix Pharmaceuticals D-671-2015
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.

Terminated Labeling / mix-up Aidapak Services, LLC D-851-2014