CLASS II ONGOING Drug recall · Reported 19 Dec 2018 · FDA Enforcement Report
Valsartan Tablets, USP 80 mg recalled by Mylan Laboratories Limited
Mylan Laboratories Limited, (Nashik FDF) is recalling Valsartan Tablets, USP 80 mg, distributed nationwide in the US. The recall was initiated on 4 Dec 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-0325-2019
- FDA event ID
- 81707
- Recalling firm
- Mylan Laboratories Limited, (Nashik FDF), Sinnar, Nashik District, N/A
- Brand
- Valsartan
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Dec 2018
- FDA classified
- 14 Dec 2018
- Reported
- 19 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 4 Dec 2018 | Recall initiated by company | |
| 14 Dec 2018 | Classified by FDA | +10 days |
| 19 Dec 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
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5813-77.
Where it was distributed
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Questions about this recall
Is Valsartan Tablets, USP 80 mg recalled?
Yes. Mylan Laboratories Limited, (Nashik FDF) recalled Valsartan Tablets, USP 80 mg on 4 Dec 2018. The recall is Class II and its status is Ongoing. Recall number D-0325-2019.
Why was it recalled?
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Which lots are affected?
Lot Numbers: 3065445, 3074880, 3074883, 3086688, 3086689, 3086710
Where was it sold?
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
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 Mylan Laboratories Limited, (Nashik FDF)
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amlodipine and Valsartan Tablets, USP 10/320 mg recalledAmlodipine And Valsartan | Mylan Laboratories Limited, (Nashik FDF) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets, USP 40 mg recalled by Mylan Laboratories LimitedValsartan | Mylan Laboratories Limited, (Nashik FDF) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg recalledValsartan And Hydrochlorothiazide | Mylan Laboratories Limited, (Nashik FDF) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Amlodipine and Valsartan Tablets, USP 5/320 mg recalledAmlodipine And Valsartan | Mylan Laboratories Limited, (Nashik FDF) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Amlodipine and Valsartan Tablets, USP 5/160 mg recalledAmlodipine And Valsartan | Mylan Laboratories Limited, (Nashik FDF) | Nitrosamine Impurity | Nationwide |
Other Valsartan recalls
All 66| 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 |