FDA Drug recall D-1039-2019
Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
- FDA Drug
- Class II
- ongoing
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90 by Aurobindo Pharma Usa, citing GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1039-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-12-31 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
Product
Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90
Reason
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Identifiers
| ndc | 65862-570-30 |
|---|---|
| ndc | 65862-570-99 |
| ndc | 65862-570-10 |
| ndc | 65862-571-90 |
| ndc | 65862-571-99 |
| ndc | 65862-571-10 |
| ndc | 65862-572-90 |
| ndc | 65862-572-99 |
| ndc | 65862-572-10 |
| ndc | 65862-573-90 |
| ndc | 65862-573-05 |
| code_info | Lot Numbers: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A,…Lot Numbers: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 472180010A, exp. date Mar 2020; 472180013A, 472180014A, exp. date Apr 2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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All Aurobindo Pharma Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1039-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.