Mylan Laboratories Limited, (Nashik FDF) recalls Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles
Mylan recalls 90-count and 500-count Valsartan/Hydrochlorothiazide tablets (320/25 mg) made in India with trace NDEA impurity. FDA confirmed impurity in API; no specific remedy stated.
Recall notice
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling certain Valsartan and Hydrochlorothiazide tablets due to trace amounts of a potential impurity found in the manufacturing process. This could pose a risk to health, though the exact danger level is not specified in the recall notice. Read more at govinfonow.com/recall/39385-mylan-valsartan-hydrochlorothiazide-tablets-recall-trace-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39385-mylan-valsartan-hydrochlorothiazide-tablets-recall-trace-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0332-2019
Cite this page
“Mylan Valsartan/Hydrochlorothiazide Tablets Recall: Trace Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39385-mylan-valsartan-hydrochlorothiazide-tablets-recall-trace-impurity-risk. Based on FDA recall #D-0332-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0332-2019%22&limit=1).
Why it’s dangerous
The FDA found trace amounts of N-nitrosodiethylamine (NDEA), a potential impurity in the active ingredient used to make these tablets. While the levels are very low, NDEA has been linked to health risks in some studies, though the exact risk here is not clearly defined.
Who’s affected
People who have the specific 90-count or 500-count bottles of Valsartan/Hydrochlorothiazide tablets (320/25 mg) with NDC numbers 0378-6325-77 or 0378-6325-05. Those taking these medications are most at risk.
How to tell if you have this one
Check for the 90-count or 500-count bottles labeled Valsartan and Hydrochlorothiazide 320/25 mg. Look for NDC numbers 0378-6325-77 or 0378-6325-05. These were made in India and sold as prescription-only products.
- Brand
Mylan- Category
Drug
All 13 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 to several major distributors, including Puerto Rico.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0320-2019 | Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93.; Lot Numbers:3064084, 3069629, 3073148, 3073149,3076093, 3077772 | 141,995 HDPE bottles | 0378-1721-93, 0378-1722-93, 0378-1723-93, 0378-1724-93 |
| D-0321-2019 | Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1722-93.; Lot numbers: 3064085, 3066063,3069638,3069639 | 76,516 HDPE bottles | 0378-1721-93, 0378-1722-93, 0378-1723-93, 0378-1724-93 |
| D-0322-2019 | Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93.; Lot Numbers: 3064086, 3066061, 3066062,3073145,3073146,3073147, 3076091, 3077619, 3082432 | 109,314 HDPE bottles | 0378-1721-93, 0378-1722-93, 0378-1723-93, 0378-1724-93 |
| D-0323-2019 | Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93.; Lot Numbers: 3066064, 3069645, 3069646, 3073142, 3073143, 3073144, 3077617 | 84,066 HDPE bottles | 0378-1721-93, 0378-1722-93, 0378-1723-93, 0378-1724-93 |
| D-0324-2019 | Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5807-93.; Lot Numbers: 3063780, 3074879, 3086684, 3086687 | 160,300 HDPE bottles | 0378-5807-93, 0378-5813-77, 0378-5814-77, 0378-5815-77 |
| D-0325-2019 | 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 Numbers: 3065445, 3074880, 3074883, 3086688, 3086689, 3086710 | 119,761 HDPE bottles | 0378-5807-93, 0378-5813-77, 0378-5814-77, 0378-5815-77 |
| D-0326-2019 | Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.; Lot Numbers: 3069019, 3069020, 3069021, 3069022, 3071354, 3071355, 3071357 3079023 3079027 3079028 3079029 3079996 3079997 3079998 3083635 3086715 3086716 3086717 3088623 | 232,180 HDPE bottles | 0378-5807-93, 0378-5813-77, 0378-5814-77, 0378-5815-77 |
| D-0327-2019 | Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.; Lot Numbers: 3063783 3063784 3063785 3064092 3064093 3064094 3070349 3070350 3070351 3070352 3070353 3070354 3079030 3079031 3079032 3079033 3080011 3080224 3081498 3081500 3087126 3088476 | 129,754 HDPE bottles | 0378-5807-93, 0378-5813-77, 0378-5814-77, 0378-5815-77 |
| D-0328-2019 | Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.; Lot numbers: 3084363, 3084364, 3093800, 3084363, 3093800 | 32,696 HDPE 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-0329-2019 | Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.; Lot numbers: 2008880 3084358 3084359 3093801 3084359 3084361 3093801 | 50,595 HDPE 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-0330-2019 | Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.; Lot numbers: 3084887 3093802 3084887 3084888 3093802 | 22,813 HDPE 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-0331-2019 | Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.; Lot numbers: 3084889 3084890 3093803 | 19,352 HDPE 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-0332-2019 | Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.; Lot numbers: 3084860 3084861 3084862 3093804 3084862 3084863 | 32,284 HDPE 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 |
What to do — step by step
Check Product Details
Identify the NDC numbers 0378-6325-77 or 0378-6325-05 on the bottle to confirm if it is recalled.
Questions people ask
Is this product safe to use?
The recall states trace impurities were found, but the exact risk level is not specified. The FDA confirmed the presence of NDEA in the manufacturing process, but no specific remedy is provided.
What should I do if I have this product?
The recall does not specify a remedy, so no action is required beyond checking if your product matches the NDC numbers listed.
How can I tell if my product is recalled?
Check for the NDC numbers 0378-6325-77 (90-count) or 0378-6325-05 (500-count) on the bottle label.
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-0332-2019 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0332-2019 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-0332-2019 (December 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0332-2019 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.