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

Not under an active recall. Valacyclovir was recalled 5 times in the past — all now closed. Most recent: Apr 25, 2024.

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 Valacyclovir. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Valacyclovir recalls on record

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

Valacyclovir Tablets USP

Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.

Completed Failed specification Viatris Inc NDC 0378-4275-77 D-0481-2024
Class II · Moderate risk

Valacyclovir Tablets USP 1 gram

Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).

Terminated Temperature excursion Hetero Labs Limited Unit V NDC 31722-705-30 D-0602-2018
Class II · Moderate risk

Valacyclovir HCl active pharmaceutical ingredient packaged in…

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-948-2015