Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Teva Pharmaceuticals USA is recalling specific lots of Amlodipine and Valsartan Tablets because FDA testing found the impurity N-nitrosodimethylamine (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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant health risks like nitrosamine impurities are categorized as Severe (Score 4), as they do not meet the Class I criteria for Critical but represent a serious potential health hazard.
Plain-English summary
Teva Pharmaceuticals USA is recalling 39,617 bottles of Amlodipine and Valsartan Tablets 10 mg/160 mg. The affected products are 30-count bottles (NDC 0093-7961-56) and 90-count bottles (NDC 0093-7691-98) manufactured in Israel by Teva Pharmaceutical Ind. Ltd. and distributed nationwide in the USA, including Puerto Rico.
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 product. The specific lots affected are # 24X012 and # 24X013.
Consumers with these specific NDCs and lot numbers should stop using the medication and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 39,617
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 (2)
- NDC 0093-7691-56 & NDC 0093-7691-98 Lot # 24X012
- 24X013
Distribution
Part of a larger recall action
This product is one of 8 recalled by Teva Pharmaceuticals USA 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.
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