Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity
Teva Pharmaceuticals USA is recalling specific lots of Amlodipine and Valsartan Tablets 5 mg/320 mg because FDA testing confirmed the presence of 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 classification is FDA Class II, and the presence of NDEA, a potential carcinogen, in a prescription drug constitutes a significant health risk warranting a Severe rating.
Plain-English summary
Teva Pharmaceuticals USA is recalling 75,883 bottles of Amlodipine and Valsartan Tablets 5 mg/320 mg. The affected products are available in 30-count bottles (NDC 0093-7692-56) and 90-count bottles (NDC 0093-7692-98). The specific lots involved are 25X028, 25X029, 25X030, 25X031, 25X032, 25X035, and 25X037. These prescription-only medications were manufactured in Israel by TEVA PHARMACEUTICAL IND. LTD. for TEVA PHARMACEUTICALS USA, INC.
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. NDEA is a potential carcinogen that can form during the manufacturing process of certain pharmaceuticals.
The affected products were distributed nationwide in the United States, including Puerto Rico. Patients and healthcare providers should check their medication bottles for the specific NDC numbers and lot numbers listed above. If the medication matches the recalled lots, patients should stop taking it and contact their healthcare provider for guidance on alternative treatment options.
The recalled product
- Product
- Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), 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
- Affected units
- 75,883
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 (7)
- NDC 0093-7692-56 & NDC 0093-7692-98 Lot # 25X028
- 25X029
- 25X030
- 25X031
- 25X032
- 25X035
- 25X037
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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