Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Teva Pharmaceuticals USA is recalling specific lots of 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 rating under the rubric. The presence of NDEA, a potential carcinogen, in a prescription medication represents a significant health risk, though no specific injuries or deaths are reported in the source text.
Plain-English summary
Teva Pharmaceuticals USA is recalling 37,957 bottles of Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg. The affected products are 30-count bottles (NDC 0093-7960-56) and 90-count bottles (NDC 0093-7690-98), specifically Lot # 21X006 and 21X007. These prescription-only medications were distributed nationwide in the United States, including Puerto Rico.
The recall was initiated following FDA laboratory testing that confirmed the presence of an impurity, N-nitrosodimethylamine (NDEA), in the product. This finding was identified as a Current Good Manufacturing Practice (CGMP) deviation.
Consumers who have these specific bottles should stop using the medication and contact their healthcare provider for guidance on alternative treatment options. The products should be returned to the pharmacy or disposed of according to local regulations.
The recalled product
- Product
- Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90-count bottles (NDC 0093-7690-98), 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
- 37,957
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 0093-7038-56 & NDC 0093-7038-98 Lot # 21X006
- 21X007
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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