The Recall Desk
SevereFDA (Drugs)·D-0306-2019·Announced 2018-12-19

Teva Recalls Amlodipine and Valsartan Tablets Due to NDEA Impurity

Teva Pharmaceuticals USA is recalling Amlodipine and Valsartan Tablets 10 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the presence of a potential carcinogenic impurity (NDEA) in a prescription medication.

Plain-English summary

Teva Pharmaceuticals USA is recalling Amlodipine and Valsartan Tablets 10 mg/320 mg, prescription-only, in 30-count and 90-count bottles. The recall involves 142,260 bottles distributed nationwide in the United States, including Puerto Rico. The specific NDC codes are 0093-7693-56 and 0093-7693-98, and the affected lot numbers range from 26X036 to 26X051.

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.

Consumers should check their medication bottles for the specific NDC codes and lot numbers listed above. If the medication matches the recalled product, patients should contact their healthcare provider or pharmacist for guidance on alternative treatment options and to return the medication.

The recalled product

Product
Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), 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
142,260

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 (15)

  • NDC 0093-7693-56 & NDC 0093-7693-98 Lot # 26X036
  • 26X038
  • 26X039
  • 26X040
  • 26X041
  • 26X042
  • 26X043
  • 26X044
  • 26X045
  • 26X046
  • 26X047
  • 26X048
  • 26X049
  • 26X050
  • 26X051

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 8 products in this recall →

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