Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b)
Mylan recalls 100-count and 500-count Diltiazem HCl 180mg capsules due to impurities found in stability testing. This may affect safety. Contact Mylan for details.
Recall notice
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling Diltiazem HCl Extended-Release Capsules (180mg) because routine stability testing found impurities that could pose safety risks. This recall affects people who have these specific bottle sizes. Read more at govinfonow.com/recall/39193-mylan-diltiazem-180mg-capsules-recall-impurities-risk-safety.
Source Summary by GovInfoNow · govinfonow.com/recall/39193-mylan-diltiazem-180mg-capsules-recall-impurities-risk-safety · Updated October 5, 2026 · FDA enforcement record: FDA #D-0506-2019
Cite this page
“Mylan Diltiazem 180mg Capsules Recall: Impurities Risk Safety.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39193-mylan-diltiazem-180mg-capsules-recall-impurities-risk-safety. Based on FDA recall #D-0506-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0506-2019%22&limit=1).
Why it’s dangerous
The recall states that routine stability testing found impurities that are out of specification. This means the medication may not be safe for use as intended, potentially causing health risks.
Who’s affected
People who have the 100-count or 500-count bottles of Diltiazem HCl 180mg capsules from Mylan. Those taking this medication are most at risk.
How to tell if you have this one
Check for 100-count bottles (NDC 0378-5280-01) or 500-count bottles (NDC 0378-5280-05) of Diltiazem HCl 180mg capsules. These are prescription-only products manufactured by Mylan.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC codes 0378-5280-01 or 0378-5280-05 on the bottle to confirm if it's recalled.
Questions people ask
Why is this medication being recalled?
The recall is due to high out of specification results found during routine stability testing, indicating potential impurities.
What should I do if I have this product?
The official notice does not specify a remedy, so contact Mylan directly for further instructions.
Is this product safe to use?
The recall indicates the product may not be safe due to impurities found in stability testing.
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-0506-2019 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0506-2019 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-0506-2019 (February 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0506-2019 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.