CLASS II ONGOING Drug recall · Reported 19 Dec 2018 · FDA Enforcement Report

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets recalled

Teva Pharmaceuticals USA is recalling Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) bottles (, distributed nationwide in the US. The recall was initiated on 27 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesNDC 0093-7038-56 & NDC 0093-7038-98 Lot # 21X006, 21X007

Quantity recalled37,957 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0309-2019
FDA event ID: 81646
Recalling firm: Teva Pharmaceuticals USA, North Wales, PA
Classification: Class II
Status: Ongoing
Recall initiated: 27 Nov 2018
FDA classified: 14 Dec 2018
Reported: 19 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Blood Pressure Medication

Timeline

27 Nov 2018	Recall initiated by company
14 Dec 2018	Classified by FDA	+17 days
19 Dec 2018	Published in enforcement report	+5 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

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 PHARMACEUTICALS USA, INC. North Wales, PA 19454.

Where it was distributed

USA Nationwide including Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Which lots are affected?

NDC 0093-7038-56 & NDC 0093-7038-98 Lot # 21X006, 21X007

Where was it sold?

USA Nationwide including Puerto Rico.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 81646

This product is part of a recall event; the main page for the event is Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) bottles recalled.

Reported	Class	Recall	Company	Reason	Where
19 Dec 2018	CLASS II	Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) bottles recalled	Teva Pharmaceuticals USA	Nitrosamine Impurity	Nationwide
19 Dec 2018	CLASS II	Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) bottles recalled	Teva Pharmaceuticals USA	Nitrosamine Impurity	Nationwide
19 Dec 2018	CLASS II	Amlodipine and Valsartan Tablets 10 mg/320 mg (a) bottles recalled	Teva Pharmaceuticals USA	Nitrosamine Impurity	Nationwide
19 Dec 2018	CLASS II	Amlodipine, Valsartan, and Hydrochlorothiazide Tablets recalled	Teva Pharmaceuticals USA	Nitrosamine Impurity	Nationwide
19 Dec 2018	CLASS II	Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) bottles recalled	Teva Pharmaceuticals USA	Nitrosamine Impurity	Nationwide
19 Dec 2018	CLASS II	Amlodipine, Valsartan, and Hydrochlorothiazide Tablets recalled	Teva Pharmaceuticals USA	Nitrosamine Impurity	Nationwide
19 Dec 2018	CLASS II	Amlodipine, Valsartan, and Hydrochlorothiazide Tablets recalled	Teva Pharmaceuticals USA	Nitrosamine Impurity	Nationwide

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All 280

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All 81

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29 Jul 2026Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
10 Jun 2026Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
20 Aug 2025Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg recalledAmlodipine And Olmesartan Medoxomil	Ascend Laboratories	Potency & Assay	Nationwide
6 Aug 2025Drug	CLASS II	Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg recalledAmlodipine Besylate And Benazepril Hydrochloride	Lupin Pharmaceuticals	Other	Nationwide
19 Jul 2023Drug	CLASS III	Amlodipine Besylate Tablets, USP 10 mg recalled by Lupin PharmaceuticalsAmlodipine Besylate	Lupin Pharmaceuticals	Potency & Assay	Nationwide