Aurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan Tablets USP 320 mg because FDA analysis confirmed the presence of trace amounts of the impurity N-nitrosodiethylamine (NDEA).
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. Per the rubric, FDA Class II recalls involving significant health risks or potential carcinogens like NDEA are categorized as Severe (Score 4), especially when no immediate hospitalizations are reported but the hazard is significant.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Valsartan Tablets USP 320 mg, 90 count bottles (NDC 65862-573-90). The recall affects specific lot numbers with expiration dates ranging from October 2019 to May 2020. The product was distributed to major distribution chains throughout the United States.
The recall was initiated because 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. NDEA is a potential carcinogen.
Patients taking this medication should contact their healthcare provider for advice on alternative treatments. Consumers should check their medication bottles for the affected lot numbers and expiration dates listed in the recall notice.
The recalled product
- Product
- VALSARTAN (VALSARTAN)
- Brand
- VALSARTAN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Drug
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 (10)
- Lot Numbers: 473180004A
- 473180005A
- exp. date Feb 2020
- 473180006A
- exp. date Mar 2020
- 473180016A
- 473180017A
- exp. date May 2020
- 473170019A
- exp. date Oct 2019
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
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Same hazard · nde contamination
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Similar recalls
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