Valsartan and Hydrochlorothiazide Tablets — Class II drug recall D-0328-2019
Ongoing recall by Mylan Laboratories Limited, (Nashik FDF), reported 2018-12-19, distributed nationwide. GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA)
| Recall number | D-0328-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Laboratories Limited, (Nashik FDF), Sinnar, Nashik District, N/A, India |
| Recall initiated | 2018-12-04 |
| Classified | 2018-12-14 |
| Reported by FDA | 2018-12-19 |
| Distributed | Nationwide (US) |
| Quantity | 32,696 hdpe |
| Reason classes | chemical contamination, specification failure |
| NDC | 00378-6321, 00378-6321-05, 00378-6321-77, 00378-6322, 00378-6322-05, 00378-6322-77, 00378-6323, 00378-6323-05, 00378-6323-77, 00378-6324, 00378-6324-05, 00378-6324-77, 00378-6325, 00378-6325-05, 00378-6325-77 |
| Lot numbers | 3084363, 3084364, 3093800 |
Product
Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
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.
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-0328-2019. 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.