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Drug recall · FDA · Published August 14, 2018

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx

Mylan recalls 120mg diltiazem capsules due to impurities. This may cause harm. Check your prescription for NDC 51079-947-08, batch 3096049.

🇺🇸 FDA recall #D-1112-2018DrugMylan ›
Take action

Contact the company & request your remedy

Recalling firmMylan Institutional, Inc. (d.b.a. UDL Laboratories)1718 Northrock Ct · Rockford, IL 61103-1201
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Mylan is recalling diltiazem capsules that may contain impurities. This could cause harm to users, especially those taking the medication as prescribed. Read more at govinfonow.com/recall/39730-mylan-diltiazem-capsules-recall-impurities-may-cause-harm.

Source Summary by GovInfoNow · govinfonow.com/recall/39730-mylan-diltiazem-capsules-recall-impurities-may-cause-harm · Updated October 6, 2026 · FDA enforcement record: FDA #D-1112-2018

Cite this page

“Mylan Diltiazem Capsules Recall: Impurities May Cause Harm.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39730-mylan-diltiazem-capsules-recall-impurities-may-cause-harm. Based on FDA recall #D-1112-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1112-2018%22&limit=1).

Why it’s dangerous

The capsules failed impurities and degradation tests. This means they may contain harmful substances that could cause harm when taken.

Who’s affected

Prescription patients using the diltiazem capsules. Those with specific medical conditions may be at higher risk.

How to tell if you have this one

Check your prescription for NDC 51079-947-08, batch 3096049. The product is a prescription-only medication with 80 capsules per carton.

  • Brand
    Mylan
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Prescription

    Look for NDC 51079-947-08 and batch 3096049 on your prescription label.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states the capsules may contain impurities that could cause harm, so they are not safe to use.

How do I know if I have the recalled product?

Check your prescription for NDC 51079-947-08 and batch 3096049.

What should I do if I have the recalled product?

The recall does not specify a remedy, so contact your doctor or pharmacist for advice.

Take action

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-1112-2018 — Mylan Mylan

Hello,

I own a Mylan that is covered by recall D-1112-2018 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-1112-2018 (August 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1112-2018 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA