The Recall Desk
SevereFDA (Drugs)·D-0981-2018·Announced 2018-08-01

Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

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 and involves a carcinogen impurity, which aligns with the rubric criteria for Severe severity (FDA Class II with significant health risks).

Plain-English summary

Teva Pharmaceuticals USA is recalling 56,603 bottles of Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg. The product is a prescription medication manufactured by Arrow Pharma (Malta) Ltd. in India and distributed by Actavis Pharma, Inc. in Parsippany, NJ. The recall covers specific lot numbers: 1191191M, 1191192M, 1191193M, 1191194M, 1191195M, 1238466M, 1238467M, 1253261M, 1256125M, and 1277709M.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of a carcinogen impurity in the active pharmaceutical ingredient (API) used to manufacture the drug product. The FDA has classified this recall as Class II, indicating a situation in which exposure to, or use of, the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected product was distributed throughout the United States, including Hawaii and Puerto Rico. Patients who have been prescribed this medication should consult their healthcare provider for guidance on alternative treatments or next steps. Consumers should check their medication bottles for the NDC 0591-2315-19 and the specific lot numbers listed above to determine if they are affected.

The recalled product

Product
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19.
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard
Affected units
56,603

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 (9)

  • Lot # 1191191M
  • 1191192M
  • 1191193M
  • 1191194M
  • 1191195M
  • 1238466M
  • 1238467M
  • 1253261M 1256125M
  • 1277709M

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

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