Acyclovir recalls

The FDA has published 15 recalls involving Acyclovir since 2013. The latest was reported on 18 Feb 2026. Most were for packaging defects. Zydus Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls15since 2013
Last 12 months1reported
Class I213% of total
Ongoing3latest 18 Feb 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 2 13%Class II 10 67%Class III 3 20%

By year

Ongoing acyclovir recalls

3 active

All acyclovir recalls, newest first

15 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIacyclovir sodium, 200 mg, 200mg added recalledFresenius Kabi CompoundingSterilityNationwide
DrugCLASS IIAcyclovir Oral Suspension, 200mg recalled by AkornAkornPotency & AssayNationwide
DrugCLASS IIAcyclovir Sodium Injection 1,000 mg per* (50 mg/mL) recalled by Eugia USAcyclovir SodiumEugia USParticulate MatterNationwide
DrugCLASS IIAcyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalledAcyclovir SodiumAuroMedics PharmaParticulate MatterNationwide
DrugCLASS IIIAcyclovir Tablets, USP, 400 mg recalled by Heritage PharmaceuticalsAcyclovirHeritage PharmaceuticalsPackaging DefectsOH
DrugCLASS IAcyclovir Sodium Injection 500mg/ (50mg/mL) recalledAcyclovirZydus PharmaceuticalsPackaging DefectsNationwide
DrugCLASS IAcyclovir Sodium Injection 1000mg/ (50mg/mL) recalledAcyclovirZydus PharmaceuticalsPackaging DefectsNationwide
DrugCLASS IIAcyclovir Tablets, USP, 400 mg recalled by Zydus Pharmaceuticals USAAcyclovirZydus Pharmaceuticals USAPackaging DefectsNationwide
DrugCLASS IIAcyclovir Tablets, USP, 400 mg dose blisters [ recalled by Apace KYAcyclovirApace KYOtherNationwide
DrugCLASS IIAcyclovir 400mg Tablet recalled by Safecor HealthSafecor HealthManufacturing (CGMP) DeviationsMA, NY
DrugCLASS IIIAcyclovir Tablets, USP, 800 mg recalled by Hetero USAAcyclovirHetero USAOtherNationwide
DrugCLASS IIAcyclovir, Tablet, 800 mg recalled by Aidapak ServicesAidapak ServicesLabeling Errors4 states
DrugCLASS IIAcyclovir, Capsule, 200 mg recalled by Aidapak ServicesAidapak ServicesLabeling Errors4 states
DrugCLASS IIIAcyclovir Oral Suspension, USP 200 mg recalled by Hi-Tech Pharmacal CoHi-Tech PharmacalPotency & AssayNationwide
DrugCLASS IIAcyclovir Tablets USP 800 mg recalled by ApotexAcyclovirApotexParticulate MatterNationwide

Should you stop taking Acyclovir?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.