CLASS II Drug recall · Reported 21 Mar 2018 · FDA Enforcement Report
Valganciclovir Tablets, USP, 450 mg recalled
Hetero Labs Limited Unit V is recalling Valganciclovir Tablets, USP, 450 mg, distributed nationwide in the US. The recall was initiated on 13 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-0601-2018
- FDA event ID
- 79142
- Recalling firm
- Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar
- Brand
- Valganciclovir
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Feb 2018
- FDA classified
- 16 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
Timeline
| 13 Feb 2018 | Recall initiated by company | |
| 16 Mar 2018 | Classified by FDA | +31 days |
| 21 Mar 2018 | Published in enforcement report | +5 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: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
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
Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60
Where it was distributed
NJ and then distributed Nationwide in the USA
Questions about this recall
Is Valganciclovir Tablets, USP, 450 mg recalled?
Yes. Hetero Labs Limited Unit V recalled Valganciclovir Tablets, USP, 450 mg on 13 Feb 2018. The recall is Class II and its status is Terminated. Recall number D-0601-2018.
Why was it recalled?
Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Which lots are affected?
Lot #s VGC17040 & VGC17041, EXP 07/2019
Where was it sold?
NJ and then distributed 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 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 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 Valganciclovir recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL recalledValganciclovir Hydrochloride For Oral | Teva Pharmaceuticals USA | Particulate Matter | Nationwide |