CLASS II ONGOING Drug recall · Reported 19 Dec 2018 · FDA Enforcement Report
Amlodipine and Valsartan Tablets, USP 5/320 mg recalled
Mylan Laboratories Limited, (Nashik FDF) is recalling Amlodipine and Valsartan Tablets, USP 5/320 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-0322-2019
- FDA event ID
- 81707
- Recalling firm
- Mylan Laboratories Limited, (Nashik FDF), Sinnar, Nashik District, N/A
- 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
Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93.
Where it was distributed
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Questions about this recall
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: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432
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 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
12 other products · FDA event 81707This product is part of a recall event; the main page for the event is Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg recalled.
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 5/160 mg recalledAmlodipine And Valsartan | Mylan Laboratories Limited, (Nashik FDF) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg recalledValsartan And Hydrochlorothiazide | Mylan Laboratories Limited, (Nashik FDF) | Nitrosamine Impurity | Nationwide |
Other Amlodipine recalls
All 81| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg recalledAmlodipine Besylate And Benazepril Hydrochloride | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Amlodipine Besylate Tablets, USP 10 mg recalled by Lupin PharmaceuticalsAmlodipine Besylate | Lupin Pharmaceuticals | Potency & Assay | Nationwide |