CLASS II Drug recall · Reported 29 Aug 2018 · FDA Enforcement Report
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg recalled
Hetero Labs Limited Unit V is recalling Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, distributed nationwide in the US. The recall was initiated on 8 Aug 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-1113-2018
- FDA event ID
- 80773
- Recalling firm
- Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar
- Brand
- Valsartan
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 8 Aug 2018
- FDA classified
- 23 Aug 2018
- Reported
- 29 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 8 Aug 2018 | Recall initiated by company | |
| 23 Aug 2018 | Classified by FDA | +15 days |
| 29 Aug 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
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets 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 31722-745-30 UPC 331722745307
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which lots are affected?
All Lots with expiration dates 7/2018 to 6/2020
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 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.
Other products in this recall event
3 other products · FDA event 80773This product is part of a recall event; the main page for the event is Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg recalledValsartan | Hetero Labs Limited Unit V | Potency & Assay | Nationwide | |
| CLASS II | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg recalledValsartan | Hetero Labs Limited Unit V | Potency & Assay | Nationwide | |
| CLASS II | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg recalledValsartan | Hetero Labs Limited Unit V | Potency & Assay | Nationwide |
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 Valsartan recalls
All 88| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Valsartan Tablets recalled by Cardinal HealthValsartan | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Valsartan Tablets 160 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets USP 80 mg recalled by Aurobindo Pharma USAValsartan | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets USP 320 mg recalled by Aurobindo Pharma USAValsartan | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |