CLASS II Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
Valacyclovir Hydrochloride Tablets recalled by Teva Pharmaceuticals USA
Teva Pharmaceuticals USA is recalling Valacyclovir Hydrochloride Tablets, distributed nationwide in the US. The recall was initiated on 8 Nov 2013 and the FDA has classified it as Class II.
Check your package
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-1061-2014
- FDA event ID
- 66872
- Recalling firm
- Teva Pharmaceuticals USA, Sellersville, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Nov 2013
- FDA classified
- 4 Feb 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 8 Nov 2013 | Recall initiated by company | |
| 4 Feb 2014 | Classified by FDA | +88 days |
| 12 Feb 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
Product as listed by the FDA
Valacyclovir Hydrochloride Tablets, 1 g, 30 count bottle, Rx only manufactured in Israel by Teva Pharmaceuticals Ind., LTD, Jerusalem, Israel, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA. NDC #0093-7259-56
Where it was distributed
Nationwide
Questions about this recall
Is Valacyclovir Hydrochloride Tablets recalled?
Yes. Teva Pharmaceuticals USA recalled Valacyclovir Hydrochloride Tablets on 8 Nov 2013. The recall is Class II and its status is Terminated. Recall number D-1061-2014.
Why was it recalled?
Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
Which lots are affected?
Lot W22042
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Teva Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
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| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
| Drug | CLASS II | Isotretinoin Capsules, USP, 40 mg Prescription Pacs recalledIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Valacyclovir recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Valacyclovir Tablets USP, 500 mg recalled by ViatrisValacyclovir Hydrochloride | Viatris | Other | Nationwide |
| Drug | CLASS II | Valacyclovir Tablets recalled by Hetero Labs Limited Unit VValacyclovir | Hetero Labs Limited Unit V | Temperature Abuse | Nationwide |
| Drug | CLASS II | Valacyclovir HCl Tablets, 500 mg blister cards recalled | American Health Packaging | Potency & Assay | Nationwide |