Aurobindo Recalls Valsartan Tablets Due to NDEA Impurity
Aurobindo Pharma USA is recalling specific lots of Valsartan 80 mg tablets because FDA analysis confirmed trace amounts of the impurity N-nitrosodiethylamine (NDEA).
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. Per the rubric, FDA Class II recalls involving significant health risks (such as carcinogenic impurities) without reported hospitalizations or deaths typically align with a Severe (4) rating, as they are not Class I (Critical) but represent a serious potential hazard.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Valsartan Tablets USP 80 mg, 90 count bottles (NDC 65862-571-90). The recall involves specific lot numbers: 471170015A (exp. Sep 2019), 471180004A, and 471180005A (exp. Feb 2019). The product is a prescription-only medication 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 currently taking these specific lots of Valsartan should contact their healthcare provider for guidance on alternative treatment options. Consumers should check their medication bottles for the affected lot numbers and expiration dates listed above.
The recalled product
- Product
- VALSARTAN (VALSARTAN)
- Brand
- VALSARTAN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Medication
- Hazard
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 Numbers: 471170015A
- exp. date Sep 2019
- 471180004A
- 471180005A
- exp. date Feb 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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