Amlodipine and Valsartan Tablets — Class II drug recall D-0318-2019
Ongoing recall by Mylan Pharmaceuticals Inc., reported 2018-12-19, distributed nationwide. CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API use
| Recall number | D-0318-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc., Morgantown, WV, United States |
| Recall initiated | 2018-11-20 |
| Classified | 2018-12-14 |
| Reported by FDA | 2018-12-19 |
| Distributed | Nationwide (US) |
| Quantity | 48,302 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 00378-1721, 00378-1721-93, 00378-1722, 00378-1722-93, 00378-1723, 00378-1723-93, 00378-1724, 00378-1724-93 |
| Lot numbers | 3061986, 3077618, 3079708, 3079709 |
| Expiration dates | 2018-11, 2019-11, 2020-01 |
Product
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.
Reason for recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0318-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.