Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Teva Pharmaceuticals USA is recalling Amlodipine, Valsartan, and Hydrochlorothiazide 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Teva Pharmaceuticals USA is recalling Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg. The recall includes 30-count bottles (NDC 0093-7809-56) and 90-count bottles (NDC 0093-7809-98). A total of 31,079 bottles are affected. The product was distributed nationwide in the United States, including Puerto Rico.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of an impurity, N-nitrosodimethylamine (NDEA), in the product. The source text does not specify which lots are affected, stating only that all lots within expiry are included.
Consumers who have this medication should contact their healthcare provider for guidance on alternative treatments. The source text does not provide specific instructions for disposal or return of the product.
The recalled product
- Product
- Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACE
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Affected units
- 31,079
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 (1)
- All lots within expiry. NDC 0093-7809-56 & NDC 0093-7809-98
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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