CLASS II Drug recall · Reported 21 Feb 2018 · FDA Enforcement Report
Famciclovir Tablets, 500 mg recalled by Hetero Labs Limited Unit V
Hetero Labs Limited Unit V is recalling Famciclovir Tablets, 500 mg, distributed nationwide in the US. The recall was initiated on 22 Dec 2017 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-0415-2018
- FDA event ID
- 78811
- Recalling firm
- Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar
- Brand
- Famciclovir
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Dec 2017
- FDA classified
- 15 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
Timeline
| 22 Dec 2017 | Recall initiated by company | |
| 15 Feb 2018 | Classified by FDA | +55 days |
| 21 Feb 2018 | 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
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.
Which lots are affected?
Lot # FMC17039, Exp 07/2019.
Where was it sold?
Nationwide in the USA.
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.
More recalls from Hetero Labs Limited Unit V
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recalledPantoprazole Sodium | Hetero Labs Limited (Unit V) | Other | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets USP, 50 mg recalled | Hetero Labs Limited (Unit V) | Other | Nationwide |
| Drug | CLASS I | Montelukast Sodium Tablets 10 mg recalled by Hetero Labs Limited Unit VMontelukast Sodium | Hetero Labs Limited Unit V | Packaging Defects | Nationwide |
| Drug | CLASS II | Montelukast Sodium Tablets, 10 mg* recalledMontelukast Sodium | Hetero Labs Limited Unit V | Other | Nationwide |
| Drug | CLASS II | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg recalledValsartan | Hetero Labs Limited Unit V | Potency & Assay | Nationwide |
Other Famciclovir recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Famciclovir Tablets, USP 500 mg recalled by Macleods PharmaceuticalsFamciclovir | Macleods Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Famciclovir tablets, 500 mg recalled by AVKARE | Avkare | Potency & Assay | Nationwide |
| Drug | CLASS II | Famciclovir, Tablet, 500 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |