CLASS III Drug recall · Reported 12 May 2021 · FDA Enforcement Report
Acyclovir Tablets, USP, 400 mg recalled by Heritage Pharmaceuticals
Heritage Pharmaceuticals is recalling Acyclovir Tablets, USP, 400 mg, distributed in Ohio. The recall was initiated on 21 Apr 2021 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-0367-2021
- FDA event ID
- 87762
- Recalling firm
- Heritage Pharmaceuticals, East Brunswick, NJ
- Brand
- Acyclovir
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Apr 2021
- FDA classified
- 6 May 2021
- Reported
- 12 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 21 Apr 2021 | Recall initiated by company | |
| 6 May 2021 | Classified by FDA | +15 days |
| 12 May 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Lot and/or Exp Date
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-01. Packaged in 150 cc white HDPE bottle
Where it was distributed
OH
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date
Which lots are affected?
Lot A120036, Exp DEC 2023
Where was it sold?
OH
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.
More recalls from Heritage Pharmaceuticals
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin Palmitate Hydrochloride For Oral Solution, USP, 75 mg recalledClindamycin Palmitate Hydrochloride | Heritage Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 75 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 100 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 50 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Desipramine Hydrochloride Tablets, USP, 10 mg bottle recalledDesipramine Hydrochloride | Heritage Pharmaceuticals | Nitrosamine Impurity | 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 I | Acyclovir Sodium Injection 500mg/ (50mg/mL) recalledAcyclovir | Zydus Pharmaceuticals | Packaging Defects | Nationwide |