Mylan Pharmaceuticals Inc. recalls Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV
Mylan recalls 100-count Amlodipine and Benazapril capsules due to cleaning process deviations in manufacturing. Products with specific NDC and lot numbers are affected.
Lower-risk recall
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling 100-count bottles of Amlodipine and Benazapril capsules that were manufactured with cleaning process deviations. This could lead to potential quality issues with the medication. Read more at govinfonow.com/recall/40594-mylan-amlodipine-and-benazapril-capsules-recall-manufacturing-quality-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/40594-mylan-amlodipine-and-benazapril-capsules-recall-manufacturing-quality-issues · Updated October 7, 2026 · FDA enforcement record: FDA #D-0820-2018
Cite this page
“Mylan Amlodipine and Benazapril Capsules Recall: Manufacturing Quality Issues.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40594-mylan-amlodipine-and-benazapril-capsules-recall-manufacturing-quality-issues. Based on FDA recall #D-0820-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0820-2018%22&limit=1).
Why it’s dangerous
The capsules were made using equipment that wasn't cleaned properly according to manufacturing procedures. This could result in medication quality issues but does not cause immediate harm.
Who’s affected
People who own or use the recalled capsules with NDC 0378-6899-01 and lot numbers 3083008 or 3086124 are affected. Those taking blood pressure medication are most at risk.
How to tell if you have this one
Check for NDC code 0378-6899-01 and lot numbers 3083008 or 3086124 on the bottle. The capsules come in 100-count bottles.
- 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 throughout United States
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0819-2018 | Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01; Lot Numbers# 3083005, 3083006, 3086121, and 3086122, exp Jan 2019 | 25,488 bottles |
| D-0820-2018 | Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01; Lot Numbers# 3083008 and 3086124, exp Jan 2019 | 12,924 bottles |
What to do — step by step
Check Product Details
Look for NDC 0378-6899-01 and lot numbers 3083008 or 3086124 on the bottle.
Questions people ask
Why is this product being recalled?
The recall is due to cleaning process deviations in manufacturing that could affect medication quality.
What should I do if I have the recalled product?
Check the product details to see if it matches the NDC and lot numbers listed. If it does, contact Mylan for further instructions.
Is there a risk of serious injury from this product?
The recall is for potential medication quality issues, not a risk of serious injury.
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-0820-2018 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0820-2018 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-0820-2018 (April 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0820-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.