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

Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) bottles recalled

Teva Pharmaceuticals U is recalling Amlodipine and Valsartan Tablets 5 mg/160 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 0093-7690-56 & NDC 0093-7690-98 Lot # 23X017, 23X018, 23X019, 23X020, 23X022, 23X023, 23X024

Quantity recalled120,394 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-0303-2019
FDA event ID: 81646
Recalling firm: Teva Pharmaceuticals U, 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 and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 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 0093-7690-56 & NDC 0093-7690-98 Lot # 23X017, 23X018, 23X019, 23X020, 23X022, 23X023, 23X024

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 21 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

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

More recalls from Teva Pharmaceuticals U

All 196

Reported	Class	Recall	Company	Reason	Where
9 Feb 2022Drug	CLASS II	Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals U	Teva Pharmaceuticals U	Potency & Assay	Nationwide
9 Feb 2022Drug	CLASS II	Doxylamine Succinate and Pyridoxine Hydrochloride recalledDoxylamine Succinate And Pyridoxine Hydrochloride	Teva Pharmaceuticals U	Potency & Assay	Nationwide
9 Feb 2022Drug	CLASS III	Mimvey (estradiol and norethindrone acetate tablets USP) recalledMimvey	Teva Pharmaceuticals U	Labeling Errors	Nationwide
9 Feb 2022Drug	CLASS III	Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg recalledMimvey	Teva Pharmaceuticals U	Labeling Errors	Nationwide
26 Jan 2022Drug	CLASS II	Brinzolamide Ophthalmic Suspension recalled by Teva Pharmaceuticals U	Teva Pharmaceuticals U	Packaging Defects	Nationwide

Other Amlodipine and valsartan recalls

All 8

Reported	Class	Recall	Company	Reason	Where
19 Dec 2018Drug	CLASS II	Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) bottles recalled	Teva Pharmaceuticals U	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Amlodipine and Valsartan Tablets 10 mg/320 mg (a) bottles recalled	Teva Pharmaceuticals U	Nitrosamine Impurity	Nationwide
19 Dec 2018Drug	CLASS II	Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) bottles recalled	Teva Pharmaceuticals U	Nitrosamine Impurity	Nationwide
5 Sep 2018Drug	CLASS II	Amlodipine and Valsartan Tablets, USP, 10 mg/160mg recalled	Torrent Pharma	Potency & Assay	Nationwide
5 Sep 2018Drug	CLASS II	Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg recalled	Torrent Pharma	Potency & Assay	Nationwide