Mylan Pharmaceuticals Inc. recalls Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan
Mylan recalls 30-count prescription Amlodipine and Valsartan tablets made in India with a confirmed impurity that could pose health risks. Consumers should contact Mylan for details.
Recall notice
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling prescription Amlodipine and Valsartan tablets (10mg/160mg, 30-count) made in India due to a confirmed impurity in the manufacturing process. This impurity, N-nitrosodiethylamine, could pose health risks to users. Read more at govinfonow.com/recall/39416-mylan-recalls-10mg-160mg-amlodipine-and-valsartan-tablets-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/39416-mylan-recalls-10mg-160mg-amlodipine-and-valsartan-tablets-due-to · Updated October 5, 2026 · FDA enforcement record: FDA #D-0312-2019
Cite this page
“Mylan recalls 10mg/160mg Amlodipine and Valsartan tablets due to impurity risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39416-mylan-recalls-10mg-160mg-amlodipine-and-valsartan-tablets-due-to. Based on FDA recall #D-0312-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0312-2019%22&limit=1).
Why it’s dangerous
The FDA confirmed the presence of N-nitrosodiethylamine (NDEA), a known impurity in the manufacturing process. This impurity has been linked to potential health risks, though the exact risk level is not specified in the recall notice.
Who’s affected
Prescription users of the specific 10mg/160mg Amlodipine and Valsartan tablets made in India. People taking these medications for hypertension or other conditions are most at risk.
How to tell if you have this one
Check for the 30-count bottle labeled 'Amlodipine and Valsartan Tablets, USP, 10 mg/160 mg' with NDC 0378-1722-93. The product was made in India and manufactured for Mylan Pharmaceuticals.
- Brand
Mylan- 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
Product was distributed throughout the United States.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0311-2019 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93.; Lot # 3066051, exp. date 3/2019 | 23,478 bottles | 0378-1721-93, 0378-1722-93, 0378-1723-93, 0378-1724-93 |
| D-0312-2019 | Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93.; Lot # 3079500, exp. date 1/2020 | 12,336 bottles | 0378-1721-93, 0378-1722-93, 0378-1723-93, 0378-1724-93 |
| D-0313-2019 | Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5813-77.; Lot # 3063782, exp. date 1/2019 | 24,709 bottles | 0378-5807-93, 0378-5813-77, 0378-5814-77, 0378-5815-77 |
| D-0314-2019 | Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5814-77.; Lot # 3071352, exp. date 7/2019 | 12,840 bottles | 0378-5807-93, 0378-5813-77, 0378-5814-77, 0378-5815-77 |
| D-0315-2019 | Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5807-93.; Lot # 3061169, exp. date 11/2018 | 63,213 bottles | 0378-5807-93, 0378-5813-77, 0378-5814-77, 0378-5815-77 |
| D-0316-2019 | Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77.; Lot # 3081499, exp. date 3/2020 Lot # 3080009, exp. date 2/2020 Lot # 3080010, exp. date 2/2020 Lot # 3079205, exp. date 1/2020 | 25,147 bottles | 0378-5807-93, 0378-5813-77, 0378-5814-77, 0378-5815-77 |
| D-0317-2019 | Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.; Lot # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019 | 5,660 bottles | 0378-6321-77, 0378-6321-05, 0378-6322-77, 0378-6322-05, 0378-6323-77, 0378-6323-05, 0378-6324-77, 0378-6324-05, 0378-6325-77, 0378-6325-05 |
| D-0318-2019 | Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.; Lot # 3061986, exp. date 11/2018 Lot # 3079709, exp. date 1/2020 Lot # 3077618, exp. date 11/2019 Lot # 3079708, exp. date 1/2020 | 48,302 bottles | 0378-1721-93, 0378-1722-93, 0378-1723-93, 0378-1724-93 |
What to do — step by step
Contact Mylan
Reach out to Mylan Pharmaceuticals for specific instructions on how to handle the recalled product.
Questions people ask
Is this product safe to use?
The recall notice states that the product contains a confirmed impurity, but does not specify if it is safe to use. Consumers should contact Mylan for details.
What is the specific impurity in the product?
The FDA confirmed the presence of N-nitrosodiethylamine (NDEA) in the product.
How can I check if I have the recalled product?
Look for the 30-count bottle labeled 'Amlodipine and Valsartan Tablets, USP, 10 mg/160 mg' with NDC 0378-1722-93, made in India.
Contact Mylan
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-0312-2019 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0312-2019 from Mylan. 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-0312-2019 (November 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0312-2019 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.