Mylan Pharmaceuticals Inc. recalls Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown,
Mylan recalls 120mg Diltiazem capsules due to impurities found in stability testing. This may cause serious injury. Stop using immediately and contact Mylan for details.
Stop using this now
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling 120mg Diltiazem Extended-Release Capsules because tests found impurities that could cause serious injury. This is a prescription-only medication that must be stopped immediately. Read more at govinfonow.com/recall/39751-mylan-diltiazem-capsules-recall-impurities-risk-serious-injury.
Source Summary by GovInfoNow · govinfonow.com/recall/39751-mylan-diltiazem-capsules-recall-impurities-risk-serious-injury · Updated October 6, 2026 · FDA enforcement record: FDA #D-1186-2018
Cite this page
“Mylan Diltiazem Capsules Recall: Impurities Risk Serious Injury.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39751-mylan-diltiazem-capsules-recall-impurities-risk-serious-injury. Based on FDA recall #D-1186-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1186-2018%22&limit=1).
Why it’s dangerous
The capsules failed stability testing for impurities that could cause serious injury. This means the medication might not work properly or could harm your health when taken.
Who’s affected
Prescription patients who have the 120mg Diltiazem Extended-Release Capsules 100-count bottle. People with high blood pressure or heart conditions are most at risk.
How to tell if you have this one
Check for the 120mg Diltiazem Extended-Release Capsules, 100-count bottle, prescription-only. Look for NDC 0378-5220-01 and batch code #3093163 with expiration date 04/2019.
- 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 III- Status
Terminated- Distribution
Distributed Nationwide in the US
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1186-2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01; Batch code # 3093163, expiration date 04/2019 | 11,799 bottles of 100 |
| D-1187-2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05; Batch code # 3093163, expiration date 04/2019 | 656 500-count bottles |
What to do — step by step
Stop Using Now
Immediately stop using the recalled Diltiazem capsules as they may cause serious injury.
Questions people ask
Is this medication safe to take?
No, the recall states the capsules have impurities that could cause serious injury. Do not take them.
How do I know if I have the recalled product?
Check for the 120mg Diltiazem Extended-Release Capsules, 100-count bottle with NDC 0378-5220-01 and batch code #3093163.
What should I do if I have the recalled product?
Stop using it immediately and contact Mylan Pharmaceuticals for instructions.
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-1186-2018 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-1186-2018 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-1186-2018 (August 7, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1186-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.