FDA Drug recall D-1035-2019
Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90
- FDA Drug
- Class II
- ongoing
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90 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-1035-2019 |
| 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 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90
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: 473180004A, 473180005A, exp. date Feb 2020; 473180006A, exp. date Mar 2020; 473180016A, 473180017A, e…Lot Numbers: 473180004A, 473180005A, exp. date Feb 2020; 473180006A, exp. date Mar 2020; 473180016A, 473180017A, exp. date May 2020; 473170019A, exp. date Oct 2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1035-2019%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.