Aurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA is recalling Amlodipine and Valsartan tablets because FDA testing found NDEA impurity levels above the acceptable daily intake.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of NDEA, a probable human carcinogen, above the acceptable daily intake level constitutes a significant health risk warranting a Severe rating.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles. The recall involves 18,408 bottles from four specific lots: VESA17013-A, VESA17014-A, VESA18001-A, and VESA18002-A, all with expiration dates in October or December 2019.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient (API) used to manufacture the product. The detected levels of NDEA were above the interim acceptable daily intake level of 0.083 parts per million.
The product was distributed to 25 distributors and retail chains, which may have further distributed the medication throughout the United States. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for disposal or replacement.
The recalled product
- Product
- AMLODIPINE AND VALSARTAN (AMLODIPINE AND VALSARTAN)
- Brand
- AMLODIPINE AND VALSARTAN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 18,408
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot # VESA17013-A
- exp. 10/2019 Lot # VESA17014-A
- exp. 10/2019 Lot # VESA18001-A
- exp. 12/2019 Lot # VESA18002-A
- exp. 12/2019
UPCs (2)
- 0365862739308
- 0365862737304
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 10 recalled by Aurobindo Pharma USA Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same brand · AMLODIPINE AND VALSARTAN
- SevereAurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23
- SevereAurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23
- SevereAurobindo Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23
- HighMylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2018-12-19
Same manufacturer · Aurobindo Pharma USA Inc.
See all →- ModerateDicyclomine Hydrochloride Capsules Recalled for Empty Capsules
FDA (Drugs) · 2026-08-12
- ModerateAmazon Basic Care Acetaminophen 325 mg Tablets Recalled Due to Discoloration
FDA (Drugs) · 2025-06-25
- HighPrescription drug recall: Aurobindo Nebivolol tablets contain excess nitrosamine impurity
FDA (Drugs) · 2024-12-25
- HighPrescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2024-12-11
- HighFDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
FDA (Drugs) · 2024-12-11
Same hazard · nde contamination
See all →- SevereRising Pharmaceuticals Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SeverePrinston Recalls Irbesartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- SeverePrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06
- SeverePrinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-02-06