The Recall Desk
SevereFDA (Drugs)·D-0308-2019·Announced 2018-12-19

Teva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

Teva Pharmaceuticals USA is recalling specific bottles 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 severity score (4) under the rubric, particularly given the presence of a potential carcinogenic impurity (NDEA).

Plain-English summary

Teva Pharmaceuticals USA is recalling 19,458 bottles of Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg. The affected products are available in 30-count bottles (NDC 0093-7810-56) and 90-count bottles (NDC 0093-7810-98) and are identified by Lot # 20X006. These prescription-only medications were manufactured in Israel by TEVA PHARMACEUTICAL IND. LTD. and 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. NDEA is a nitrosamine impurity that is a potential carcinogen.

Consumers who have this specific medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The affected products are identified by the specific NDC codes and lot number listed above.

The recalled product

Product
Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 90-count bottles (NDC 0093-7810-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMAC
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard
Affected units
19,458

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)

  • NDC 0093-7810-56 & NDC 0093-7810-98 Lot # 20X006

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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Same hazard · nitrosamine impurity

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