CLASS II Drug recall · Reported 4 Dec 2013 · FDA Enforcement Report
Acyclovir Tablets USP 800 mg recalled by Apotex
Apotex is recalling Acyclovir Tablets USP 800 mg ,(, distributed nationwide in the US. The recall was initiated on 17 Jul 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-017-2014
- FDA event ID
- 66807
- Recalling firm
- Apotex, Toronto, N/A
- Brand
- Acyclovir
- Manufacturer
- Apotex Corp.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2013
- FDA classified
- 22 Nov 2013
- Reported
- 4 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 17 Jul 2013 | Recall initiated by company | |
| 22 Nov 2013 | Classified by FDA | +128 days |
| 4 Dec 2013 | Published in enforcement report | +12 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 Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Product as listed by the FDA
Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp.,Weston, Florida 33326.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.
Which lots are affected?
Lot # KF2199 Exp 07/15
Where was it sold?
Nationwide and Puerto Rico
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 Acyclovir recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | acyclovir sodium, 200 mg, 200mg added recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | Acyclovir Oral Suspension, 200mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Acyclovir Sodium Injection 1,000 mg per* (50 mg/mL) recalled by Eugia USAcyclovir Sodium | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS II | Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalledAcyclovir Sodium | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Acyclovir Tablets, USP, 400 mg recalled by Heritage PharmaceuticalsAcyclovir | Heritage Pharmaceuticals | Packaging Defects | OH |