Mylan Pharmaceuticals Inc. recalls Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
Mylan recalls 150mg Nizatidine capsules due to trace NDMA impurity. This potential carcinogen may pose health risks. Consumers should check product details and follow official guidance.
Lower-risk recall
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling 150mg Nizatidine capsules (Rx only) because trace amounts of a possible carcinogen called NDMA were found in the manufacturing process. This could pose health risks, especially with long-term use. Read more at govinfonow.com/recall/37483-mylan-nizatidine-capsules-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37483-mylan-nizatidine-capsules-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0791-2020
Cite this page
“Mylan Nizatidine Capsules Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37483-mylan-nizatidine-capsules-recall-ndma-impurity-risk. Based on FDA recall #D-0791-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0791-2020%22&limit=1).
Why it’s dangerous
Trace amounts of NDMA, a potential carcinogen, were detected in the manufacturing process. While the levels are very low, repeated exposure over time could increase cancer risk. The impurity is not present in the final product but was found during production.
Who’s affected
People who have prescription Nizatidine capsules with NDC 0378-5150-91. Those using the medication long-term may be at slightly higher risk due to the impurity.
How to tell if you have this one
Check for the NDC code 0378-5150-91 on the capsule packaging. The product was manufactured with lot number 3086746 and expired May 2020.
- Brand
Mylan- Category
Drug
All 2 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
Terminated- Distribution
Product was distributed to wholesalers, distributors , retail pharmacies, charitable organizations and mail order pharmacies throughout the United States and the product may have been further distributed.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0791-2020 | Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.; Lot Number: 3086746, exp. date May 2020 | 31,736 bottles of 60 capsules |
| D-0792-2020 | Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.; Lot # 3082876, exp. date January 2020 Lot # 3082877, exp. date January 2020 | 16,944 bottles of 30 capsules |
What to do — step by step
Check Product Details
Look for the NDC code 0378-5150-91 on the capsule packaging.
Questions people ask
Is this product safe to use?
The recall states trace NDMA was found during manufacturing, but the product is not considered unsafe for short-term use. Consumers should check if they have the recalled product.
What should I do if I have this product?
Check the NDC code on the packaging. If you have the recalled product, contact Mylan for guidance.
Is there a risk of serious injury from this product?
The recall does not mention any risk of serious injury or immediate harm. The hazard is related to potential long-term health effects from trace impurities.
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-0791-2020 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0791-2020 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-0791-2020 (January 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0791-2020 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.