CLASS II Drug recall · Reported 11 Dec 2013 · FDA Enforcement Report

Valacyclovir HCl Tablets, 500 mg blister cards recalled

American Health Packaging is recalling Valacyclovir HCl Tablets, 500 mg blister cards, distributed nationwide in the US. The recall was initiated on 2 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesThe following product was affected: AHP Lot #: 130007 Expiration Date: 01/31/2014 Carton NDC #: 68084-633-01 Single Dose NDC #: 68084-633-11

Quantity recalled1536 cartons

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-323-2014
FDA event ID: 66451
Recalling firm: American Health Packaging, Columbus, OH
Classification: Class II
Status: Terminated
Recall initiated: 2 Aug 2013
FDA classified: 5 Dec 2013
Reported: 11 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

2 Aug 2013	Recall initiated by company
5 Dec 2013	Classified by FDA	+125 days
11 Dec 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subpotent

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only, Packaged and Distributed by: American Health Packaging, Columbus, OH NDC 68084-633-01

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Subpotent

Which lots are affected?

The following product was affected: AHP Lot #: 130007 Expiration Date: 01/31/2014 Carton NDC #: 68084-633-01 Single Dose NDC #: 68084-633-11

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Other Valacyclovir recalls

All 4

Reported	Class	Recall	Company	Reason	Where
8 May 2024Drug	CLASS III	Valacyclovir Tablets USP, 500 mg recalled by ViatrisValacyclovir Hydrochloride	Viatris	Other	Nationwide
21 Mar 2018Drug	CLASS II	Valacyclovir Tablets recalled by Hetero Labs Limited Unit VValacyclovir	Hetero Labs Limited Unit V	Temperature Abuse	Nationwide
12 Feb 2014Drug	CLASS II	Valacyclovir Hydrochloride Tablets recalled by Teva Pharmaceuticals USA	Teva Pharmaceuticals USA	Other	Nationwide