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 recalls 15 since 2013
Last 12 months 1 reported
Class I 2 13% of total
Ongoing 3 latest 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%
Why acyclovir is recalled
Ongoing acyclovir recalls 3 active
All acyclovir recalls, newest first 15 total
Reported Class Recall Company Reason Where 18 Feb 2026 Drug CLASS II acyclovir sodium, 200 mg, 200mg added recalled Fresenius Kabi Compounding Sterility Nationwide 7 Jun 2023 Drug CLASS II Acyclovir Oral Suspension, 200mg recalled by Akorn Akorn Potency & Assay Nationwide 11 Jan 2023 Drug CLASS II Acyclovir Sodium Injection 1,000 mg per* (50 mg/mL) recalled by Eugia US Acyclovir Sodium Eugia US Particulate Matter Nationwide 26 Oct 2022 Drug CLASS II Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalled Acyclovir Sodium AuroMedics Pharma Particulate Matter Nationwide 12 May 2021 Drug CLASS III Acyclovir Tablets, USP, 400 mg recalled by Heritage Pharmaceuticals Acyclovir Heritage Pharmaceuticals Packaging Defects OH 7 Apr 2021 Drug CLASS I Acyclovir Sodium Injection 500mg/ (50mg/mL) recalled Acyclovir Zydus Pharmaceuticals Packaging Defects Nationwide 7 Apr 2021 Drug CLASS I Acyclovir Sodium Injection 1000mg/ (50mg/mL) recalled Acyclovir Zydus Pharmaceuticals Packaging Defects Nationwide 15 May 2019 Drug CLASS II Acyclovir Tablets, USP, 400 mg recalled by Zydus Pharmaceuticals USA Acyclovir Zydus Pharmaceuticals USA Packaging Defects Nationwide 7 Mar 2018 Drug CLASS II Acyclovir Tablets, USP, 400 mg dose blisters [ recalled by Apace KY Acyclovir Apace KY Other Nationwide 21 Jun 2017 Drug CLASS II Acyclovir 400mg Tablet recalled by Safecor Health Safecor Health Manufacturing (CGMP) Deviations MA, NY 14 Jun 2017 Drug CLASS III Acyclovir Tablets, USP, 800 mg recalled by Hetero USA Acyclovir Hetero USA Other Nationwide 29 Jan 2014 Drug CLASS II Acyclovir, Tablet, 800 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 29 Jan 2014 Drug CLASS II Acyclovir, Capsule, 200 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 1 Jan 2014 Drug CLASS III Acyclovir Oral Suspension, USP 200 mg recalled by Hi-Tech Pharmacal Co Hi-Tech Pharmacal Potency & Assay Nationwide 4 Dec 2013 Drug CLASS II Acyclovir Tablets USP 800 mg recalled by Apotex Acyclovir Apotex Particulate Matter Nationwide
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.