CLASS III Drug recall · Reported 14 Jun 2017 · FDA Enforcement Report
Acyclovir Tablets, USP, 800 mg recalled by Hetero USA
Hetero USA is recalling Acyclovir Tablets, USP, 800 mg, distributed nationwide in the US. The recall was initiated on 27 Apr 2017 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-0897-2017
- FDA event ID
- 77122
- Recalling firm
- Hetero USA, Piscataway, NJ
- Brand
- Acyclovir
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Apr 2017
- FDA classified
- 7 Jun 2017
- Reported
- 14 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 27 Apr 2017 | Recall initiated by company | |
| 7 Jun 2017 | Classified by FDA | +41 days |
| 14 Jun 2017 | Published in enforcement report | +7 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 Substance: human hair melded into tablet.
Product as listed by the FDA
Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: human hair melded into tablet.
Which lots are affected?
Lot # ACY16075 Exp. 09/2018
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.
More recalls from Hetero USA
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pantoprazole Sodium Delayed Release Tablets USP 40mg recalledPantoprazole Sodium | Hetero USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Entecavir Tablets 0.5 mg per container recalled by Hetero USAEntecavir | Hetero USA | Potency & Assay | NJ |
| Drug | CLASS III | Montelukast sodium tablets, 10 mg recalled by Hetero USAMontelukast Sodium | Hetero USA | Packaging Defects | 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 |