CLASS III Drug recall · Reported 1 Jan 2014 · FDA Enforcement Report
Acyclovir Oral Suspension, USP 200 mg recalled by Hi-Tech Pharmacal Co
Hi-Tech Pharmacal is recalling Acyclovir Oral Suspension, USP 200 mg, distributed nationwide in the US. The recall was initiated on 28 Oct 2013 and the FDA has classified it as Class III.
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-389-2014
- FDA event ID
- 66675
- Recalling firm
- Hi-Tech Pharmacal, Amityville, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Oct 2013
- FDA classified
- 24 Dec 2013
- Reported
- 1 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 28 Oct 2013 | Recall initiated by company | |
| 24 Dec 2013 | Classified by FDA | +57 days |
| 1 Jan 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
Failed Stability Specification; product viscosity and or pH are below specification.
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
Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701. NDC 50383-810-16.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Stability Specification; product viscosity and or pH are below specification.
Which lots are affected?
Batch no: 1) 614463 (exp. 03/2014), 2) 612905 (exp. 12/2013), 3) 614923 (exp. 03/2014), 4) 615852 (exp. 05/2014), 5) 615855 (exp. 05/2014), 6) 616689 (exp. 07/2014), 7) 616692 (exp. 07/2014).
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 |