Teva Pharmaceuticals USA recalls Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC
Teva recalls 5 mg/160 mg Amlodipine and Valsartan tablets due to FDA-confirmed NDEA impurity. Stop using affected bottles with specific NDC numbers.
Lower-risk recall
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Contact the company & request your remedy
What happened, in plain English
Teva Pharmaceuticals USA is recalling certain Amlodipine and Valsartan tablets because FDA testing found a harmful impurity. This impurity, N-nitrosodimethylamine (NDEA), could pose a cancer risk with long-term use. Affected products include specific 30-count and 90-count bottles with listed NDC numbers. Read more at govinfonow.com/recall/39402-teva-amlodipine-valsartan-tablets-recall-ndea-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39402-teva-amlodipine-valsartan-tablets-recall-ndea-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0303-2019
Cite this page
“Teva Amlodipine/Valsartan Tablets Recall: NDEA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39402-teva-amlodipine-valsartan-tablets-recall-ndea-impurity-risk. Based on FDA recall #D-0303-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0303-2019%22&limit=1).
Why it’s dangerous
FDA laboratory testing confirmed the presence of N-nitrosodimethylamine (NDEA), a known carcinogen, in the medication. This impurity could increase cancer risk with long-term use of the product.
Who’s affected
People who have the recalled 30-count or 90-count bottles of Amlodipine and Valsartan tablets (5 mg/160 mg) with specific NDC numbers. Those using these medications for blood pressure or heart conditions are most at risk.
How to tell if you have this one
Check for the NDC numbers 0093-7690-56 (30-count bottles) or 0093-7690-98 (90-count bottles). The lot numbers 23X017 through 23X024 also indicate affected products.
- Brand
Teva- Category
Drug
All 8 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
USA Nationwide including Puerto Rico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0303-2019 | 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.; NDC 0093-7690-56 & NDC 0093-7690-98 Lot # 23X017, 23X018, 23X019, 23X020, 23X022, 23X023, 23X024 | 120,394 bottles |
| D-0304-2019 | Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.; NDC 0093-7691-56 & NDC 0093-7691-98 Lot # 24X012, 24X013 | 39,617 bottles |
| D-0305-2019 | Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.; NDC 0093-7692-56 & NDC 0093-7692-98 Lot # 25X028, 25X029, 25X030, 25X031, 25X032, 25X035, 25X037 | 75,883 bottles |
| D-0306-2019 | Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.; NDC 0093-7693-56 & NDC 0093-7693-98 Lot # 26X036, 26X038, 26X039, 26X040, 26X041, 26X042, 26X043, 26X044, 26X045, 26X046, 26X047, 26X048, 26X049, 26X050, 26X051 | 142,260 bottles |
| D-0307-2019 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) & 90-count bottles (NDC 0093-7807-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.; NDC 0093-7807-56 & 0093-7807-98 Lot # 18X010, 18X011 | 41,572 bottles |
| D-0308-2019 | 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 PHARMACEUTICALS USA, INC. North Wales, PA 19454.; NDC 0093-7810-56 & NDC 0093-7810-98 Lot # 20X006 | 19,458 bottles |
| D-0309-2019 | 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.; NDC 0093-7038-56 & NDC 0093-7038-98 Lot # 21X006, 21X007 | 37,957 bottles |
| D-0310-2019 | Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90-count bottles (NDC 0093-7809-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.; All lots within expiry. NDC 0093-7809-56 & NDC 0093-7809-98 | 31,079 bottles |
What to do — step by step
Check Product Details
Identify the NDC numbers and lot numbers on the bottle to confirm if it's affected.
Questions people ask
Is this product safe to use?
The FDA confirmed the presence of a harmful impurity, NDEA, which could increase cancer risk with long-term use. Do not use affected products.
What NDC numbers are affected?
Affected NDC numbers are 0093-7690-56 (30-count bottles) and 0093-7690-98 (90-count bottles).
How can I tell if my product is recalled?
Check for NDC numbers 0093-7690-56 or 0093-7690-98 and lot numbers 23X017 through 23X024 on the bottle.
Contact Teva
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0303-2019 — Teva Teva Hello, I own a Teva that is covered by recall D-0303-2019 from Teva. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0303-2019 (November 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0303-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.