Aurobindo Recalls Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA is recalling Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.
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, which corresponds to a 'Severe' rating under the rubric, particularly given the presence of a nitrosamine impurity (NDEA) which is a known carcinogen.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Valsartan Tablets USP 160 mg, 90 count bottles, NDC 65862-572-90. The recall was initiated after FDA analysis confirmed the presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA), in the active pharmaceutical ingredient (API) used to manufacture the product.
The affected product was distributed to major distribution chains throughout the United States. Specific lot numbers involved in this recall include 472180001A through 472180004A (exp. Jan 2020), 472180007A through 472180010A (exp. Mar 2020), and 472180013A and 472180014A (exp. Apr 2020).
Consumers and healthcare providers should check their inventory for these specific lot numbers. If the product is found, it should be returned to the pharmacy or distributor for replacement or refund. Patients should consult their healthcare provider for alternative treatment options if they are currently taking the recalled medication.
The recalled product
- Product
- VALSARTAN (VALSARTAN)
- Brand
- VALSARTAN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Medication
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 (13)
- Lot Numbers: 472180001A
- 472180002A
- 472180003A
- 472180004A
- exp. date Jan 2020
- 472180007A
- 472180008A
- 472180009A
- 472180010A
- exp. date Mar 2020
- 472180013A
- 472180014A
- exp. date Apr 2020
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 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 5 products in this recall →Related recalls
Same brand · VALSARTAN
- ModerateCardinal Health Recalls Valsartan Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAurobindo 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
- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-01-23
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 · nitrosamine impurity
See all →- HighEnovachem duloxetine capsules exceed the nitrosamine acceptable intake limit
FDA (Drugs) · 2026-06-10
- HighCipla cinacalcet 60 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCipla cinacalcet 30 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighCipla cinacalcet 90 mg tablets exceed the nitrosamine daily intake limit
FDA (Drugs) · 2026-04-22
- HighPrazosin hydrochloride 100-count bottles recalled over nitrosamine impurity
FDA (Drugs) · 2026-04-08