Mylan Diltiazem Capsules Recall: Impurities May Cause Harm
Mylan recalls 120mg Diltiazem HCl Extended-release Capsules due to failed impurities tests. Products with NDC 0378-5220-01 or 0378-5220-05 may have harmful levels of a known compound.
Lower-risk recall
Failed Impurities/Degradation Specifications: OOS results for known compound.
Contact the company
What happened, in plain English
Mylan is recalling Diltiazem HCl Extended-release Capsules (120mg) because lab tests found impurities that could be harmful. This affects specific batches sold between 2016 and 2017. The recall is for prescription-only medication. Read more at govinfonow.com/recall/42261-mylan-diltiazem-capsules-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/42261-mylan-diltiazem-capsules-recall-impurities-may-cause-harm · Updated October 9, 2026 · FDA enforcement record: FDA #D-0151-2017
Cite this page
“Mylan Diltiazem Capsules Recall: Impurities May Cause Harm.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42261-mylan-diltiazem-capsules-recall-impurities-may-cause-harm. Based on FDA recall #D-0151-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0151-2017%22&limit=1).
Why it’s dangerous
The capsules failed impurities tests, meaning they contain harmful levels of a known compound. This could cause adverse effects in people taking the medication, though the exact risk level isn't specified in the recall.
Who’s affected
Prescription holders of the specific Diltiazem capsules with NDC numbers 0378-5220-01 or 0378-5220-05 are affected. Patients taking this medication for blood pressure or chest pain are most at risk.
How to tell if you have this one
Check for the NDC numbers 0378-5220-01 or 0378-5220-05 on the product label. The capsules are prescription-only and come in 100-count or 500-count bottles.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Product Label
Look for NDC numbers 0378-5220-01 or 0378-5220-05 on the bottle to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0151-2017 (November 3, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0151-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 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.