Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0602-2018·Announced 2018-03-21

Hetero Labs Recalls Valacyclovir Tablets Due to Temperature Exposure

Hetero Labs Limited is recalling Valacyclovir Tablets USP 1 gram because they were exposed to higher temperatures during transport. The recall covers 48,132 bottles distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is temperature exposure, which is a quality control issue rather than a direct contamination or structural defect, and no illnesses or injuries are reported in the source text.

Plain-English summary

Hetero Labs Limited Unit V is recalling Valacyclovir Tablets USP 1 gram, 30-count bottles, manufactured for Camber Pharmaceuticals, Inc. The recall involves 48,132 bottles of the prescription medication, identified by Lot # VLC17027 with an expiration date of 07-2019. The product was distributed in New Jersey and then nationwide in the United States.

The recall was initiated because the Valacyclovir Tablets, along with Valganciclovir Tablets USP 450 mg and Famciclovir complaint batches, were exposed to higher temperatures at an airport or in cargo. This temperature abuse occurred within the same consignment as the previously recalled Famciclovir batch (D-0415-2018).

Consumers and healthcare providers should check their inventory for Valacyclovir Tablets USP 1 gram with Lot # VLC17027 and NDC # 31722-705-30. If found, these products should be discontinued and returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this specific lot.

The recalled product

Product: VALACYCLOVIR (VALACYCLOVIR)
Brand: VALACYCLOVIR
Manufacturer: Hetero Labs Limited Unit V
Category: Drug — Prescription Medication
Hazard: temperature-abuse
quality-control

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 (1)

Lot # VLC17027 Exp 07-2019

UPCs (2)

0331722704304
0331722705301

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Hetero Labs Limited Unit V under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Hetero Labs Limited Unit V

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Same hazard · temperature abuse