CLASS II Drug recall · Reported 21 Jun 2017 · FDA Enforcement Report
Acyclovir 400mg Tablet recalled by Safecor Health
Safecor Health is recalling Acyclovir 400mg Tablet, distributed in Massachusetts, New York. The recall was initiated on 7 Jul 2016 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-0903-2017
- FDA event ID
- 74822
- Recalling firm
- Safecor Health, Woburn, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jul 2016
- FDA classified
- 12 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 7 Jul 2016 | Recall initiated by company | |
| 12 Jun 2017 | Classified by FDA | +340 days |
| 21 Jun 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305
Where it was distributed
MA and NY
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot # A25591, Exp. 02/22/2017
Where was it sold?
MA and NY
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.
Other products in this recall event
5 other products · FDA event 74822This product is part of a recall event; the main page for the event is Calcium Carbonate 600mg/Vitamin D recalled by Safecor Health.
More recalls from Safecor Health
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 2.5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 10 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 20 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
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 |