CLASS II Drug recall · Reported 7 Mar 2018 · FDA Enforcement Report
Acyclovir Tablets, USP, 400 mg dose blisters [ recalled by Apace KY
Apace KY is recalling Acyclovir Tablets, USP, 400 mg dose blisters [, distributed nationwide in the US. The recall was initiated on 9 Feb 2018 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-0544-2018
- FDA event ID
- 79194
- Recalling firm
- Apace KY, Fountain Run, KY
- Brand
- Acyclovir
- Manufacturer
- AvPAK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Feb 2018
- FDA classified
- 23 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 9 Feb 2018 | Recall initiated by company | |
| 23 Feb 2018 | Classified by FDA | +14 days |
| 7 Mar 2018 | 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 Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Product as listed by the FDA
Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478
Where it was distributed
Nationwide
Questions about this recall
Is Acyclovir Tablets, USP, 400 mg dose blisters [ recalled?
Yes. Apace KY recalled Acyclovir Tablets, USP, 400 mg dose blisters [ on 9 Feb 2018. The recall is Class II and its status is Terminated. Recall number D-0544-2018.
Why was it recalled?
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
Which lots are affected?
Lot: 19900, exp 05/2019
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 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Apace KY
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|---|---|---|---|---|---|
| Drug | CLASS II | Cyclobenzaprine HCl Tablets, USP, 5 mg Unit Dose recalled by Apace KY | Apace KY | Other | KY |
| Drug | CLASS II | Amantadine HCl Capsules, USP, 100 mg recalled by Apace KY | Apace KY | Other | KY |
| Drug | CLASS III | Minocycline Hydrochloride Capsules USP, 100 mg* Dose blisters recalled | Apace KY | Labeling Errors | Nationwide |
| Drug | CLASS III | Enalapril Maleate Tablet, USP 5mg, Rx, Apace Packaging LLC, Ft recalled | Apace KY | Packaging Defects | Nationwide |
Other Acyclovir recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS I | Acyclovir Sodium Injection 500mg/ (50mg/mL) vial recalledAcyclovir | Zydus Pharmaceuticals (USA) | Packaging Defects | Nationwide |