Mylan Recalls Valsartan Tablets Due to NDEA Impurity
Mylan is recalling Valsartan 320 mg tablets because FDA analysis found 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 FDA classified this recall as Class II. Per the rubric, an FDA Class II recall involving a significant health hazard (NDEA impurity) corresponds to a severity score of 4 (Severe).
Plain-English summary
Mylan Laboratories Limited is recalling Valsartan Tablets, USP 320 mg, 90-count bottles. The recall involves 129,754 HDPE bottles distributed throughout the United States, including Puerto Rico.
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. The agency has classified this recall as Class II.
Consumers should check their medication for the specific lot numbers listed in the recall notice. If the medication matches the recalled lots, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- VALSARTAN (VALSARTAN)
- Brand
- VALSARTAN
- Manufacturer
- Mylan Laboratories Limited, (Nashik FDF)
- Category
- Drug — Prescription Medication
- Affected units
- 129,754
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (4)
- 0303785815778
- 0303785813774
- 0303785807933
- 0303785814771
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 13 recalled by Mylan Laboratories Limited, (Nashik FDF) 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 13 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 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
Same manufacturer · Mylan Laboratories Limited, (Nashik FDF)
See all →- SevereMylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2018-12-19
- HighMylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2018-12-19
- SevereMylan Recalls Valsartan and Hydrochlorothiazide Tablets Due to NDEA Impurity
FDA (Drugs) · 2018-12-19
- SevereMylan Recalls Valsartan Tablets Due to Trace NDEA Impurity
FDA (Drugs) · 2018-12-19
- SevereMylan Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2018-12-19
Same hazard · impurity
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FDA (Drugs) · 2026-09-02
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- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
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- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17