Need Help?

Speak with a live customer support representative.

Or call us at 1-800-RITE AID (1-800-748-3243).

Chat Now

Recall 2018 - Teva - Consumer - Amlodipine Valsartan Tablets and Amlodipine Valsartan and HCTZ Tablets


Urgent Recall Notice

Amlodipine and Valsartan Tablets

Lot # 

Exp. Date

Product Description / Strength

Bottle Size

NDC

23X018

11/30/2018

Amlodipine and Valsartan Tablets 5mg/160 mg   

30 Count

00093769056

23X019

11/30/2018

Amlodipine and Valsartan Tablets 5mg/160 mg   

30 Count

00093769056

23X020

11/30/2018

Amlodipine and Valsartan Tablets 5mg/160 mg   

30 Count

00093769056

23X022

04/30/2019

Amlodipine and Valsartan Tablets 5mg/160 mg   

30 Count

00093769056

23X023

04/30/2019

Amlodipine and Valsartan Tablets 5mg/160 mg   

30 Count

00093769056

24X012

11/30/2018

Amlodipine and Valsartan Tablets 10mg/160 mg   

30 Count

00093769156

24X013

11/30/2018

Amlodipine and Valsartan Tablets 10mg/160 mg   

30 Count

00093769156

25X029

11/30/2018

Amlodipine and Valsartan Tablets 5 mg/320 mg

30 Count

00093769256

25X030

11/30/2018

Amlodipine and Valsartan Tablets 5 mg/320 mg

30 Count

00093769256

25X031

11/30/2018

Amlodipine and Valsartan Tablets 5 mg/320 mg

30 Count

00093769256

25X032

11/30/2018

Amlodipine and Valsartan Tablets 5 mg/320 mg

30 Count

00093769256

25X035

04/30/2019

Amlodipine and Valsartan Tablets 5 mg/320 mg

30 Count

00093769256

25X037

04/30/2019

Amlodipine and Valsartan Tablets 5 mg/320 mg

30 Count

00093769256

26X039

11/30/2018

Amlodipine and Valsartan Tablets 10 mg/320 mg

30 Count

00093769356

26X040

11/30/2018

Amlodipine and Valsartan Tablets 10 mg/320 mg

30 Count

00093769356

26X041

11/30/2018

Amlodipine and Valsartan Tablets 10 mg/320 mg

30 Count

00093769356

26X042

11/30/2018

Amlodipine and Valsartan Tablets 10 mg/320 mg

30 Count

00093769356

26X043

11/30/2018

Amlodipine and Valsartan Tablets 10 mg/320 mg

30 Count

00093769356

26X046

04/30/2019

Amlodipine and Valsartan Tablets 10 mg/320 mg

30 Count

00093769356

26X047

04/30/2019

Amlodipine and Valsartan Tablets 10 mg/320 mg

30 Count

00093769356

26X048

04/30/2019

Amlodipine and Valsartan Tablets 10 mg/320 mg

30 Count

00093769356

26X049

04/30/2019

Amlodipine and Valsartan Tablets 10 mg/320 mg

30 Count

00093769356

26X050

04/30/2019

Amlodipine and Valsartan Tablets 10 mg/320 mg

30 Count

00093769356

26X051

04/30/2019

Amlodipine and Valsartan Tablets 10 mg/320 mg

30 Count

00093769356

23X017

11/30/2018

Amlodipine and Valsartan Tablets 5mg/160 mg   

90 Count

00093769098

23X018

11/30/2018

Amlodipine and Valsartan Tablets 5mg/160 mg   

90 Count

00093769098

23X019

11/30/2018

Amlodipine and Valsartan Tablets 5mg/160 mg   

90 Count

00093769098

23X023

04/30/2019

Amlodipine and Valsartan Tablets 5mg/160 mg   

90 Count

00093769098

23X024

04/30/2019

Amlodipine and Valsartan Tablets 5mg/160 mg   

90 Count

00093769098

24X012

11/30/2018

Amlodipine and Valsartan Tablets 10mg/160 mg   

90 Count

00093769198

25X028

11/30/2018

Amlodipine and Valsartan Tablets 5 mg/320 mg

90 Count

00093769298

25X029

11/30/2018

Amlodipine and Valsartan Tablets 5 mg/320 mg

90 Count

00093769298

26X036

11/30/2018

Amlodipine and Valsartan Tablets 10 mg/320 mg

90 Count

00093769398

26X038

11/30/2018

Amlodipine and Valsartan Tablets 10 mg/320 mg

90 Count

00093769398

26X039

11/30/2018

Amlodipine and Valsartan Tablets 10 mg/320 mg

90 Count

00093769398

26X044

04/30/2019

Amlodipine and Valsartan Tablets 10 mg/320 mg

90 Count

00093769398

26X045

04/30/2019

Amlodipine and Valsartan Tablets 10 mg/320 mg

90 Count

00093769398



Amlodipine Valsartan and Hydrochlorothiazide Tablets

Lot # 

Exp. Date

Product Description / Strength

Bottle Size

NDC

21X006

11/30/2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg 

30 Count

00093703856

21X007

02/28/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg 

30 Count

00093703856

18X010

02/28/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg

30 Count

00093780756

18X011

02/28/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg

30 Count

00093780756

22X045

02/28/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg

30 Count

00093780956

22X046

02/28/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg

30 Count

00093780956

22X047

02/28/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg

30 Count

00093780956

20X006

11/30/2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg

30 Count

00093781056

21X006

11/30/2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg 

90 Count

00093703898

18X010

02/28/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg

90 Count

00093780798

22X045

02/28/2019

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg

90 Count

00093780998

20X006

11/30/2018

Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg

90 Count

00093781098



Teva Pharmaceuticals USA, Inc. is voluntarily recalling to the CONSUMER LEVEL All Lots Within Expiry of the above listed Amlodipine and Valsartan Tablets that were distributed under the Teva Pharmaceuticals label. These lots are being recalled due to an impurity, N-nitrosodiethylamine (NDEA), which is above specification limits in the Valsartan Active Pharmaceutical Ingredient (API) that was manufactured by Mylan Laboratories Limited in India. This product started to ship as of January 20, 2017.

As a consumer, your first course of action should be to consult with your pharmacist or physician who can advise you about an alternative treatment prior to discontinuation of the medication. If you are taking either Amlodipine and Valsartan Tablets or Amlodipine Valsartan and Hydrochlorothiazide Tablets that are within the subject of these recalls you should continue taking your medication, as the immediate risk of harm to your health may be higher if the treatment is stopped immediately without any alternative treatment. The specific lots of the Valsartan products being recalled are listed on the attached tables.

Once your physician has identified an alternative medication to treat your condition, we request that you return any remaining product in your possession to your local pharmacy where you obtained the product. Returning the product via your local pharmacy may be the most convenient process for you and you may receive reimbursement. This process will ensure that the product is properly returned to Teva as part of this voluntary recall. In the event that your pharmacy does not accept the product back you may contact Teva's product recall processor Inmar at 877-297-8404 to receive instructions on how to return the product.

Inmar's hours of operation are 9 am to 5 pm Eastern Time, Monday - Friday.

This recall is being conducted with the knowledge of the FDA.

Contact:

Option 3: Teva Pharmaceuticals 877-297-8404