Mylan Pharmaceuticals Inc. recalls Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC
Mylan recalls 5mg Tacrol: Risk of foreign 1mg capsules in 5mg bottles. Stop using if you have the specific lot numbers.
Use caution until it’s fixed
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Contact the company & request your remedy
What happened, in plain English
Mylan is recalling 5mg Tacrolimus capsules due to potential contamination with 1mg capsules. This could cause incorrect dosing if taken without knowing the actual strength. Read more at govinfonow.com/recall/37289-mylan-tacrolimus-capsules-5mg-recall-foreign-tablet-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37289-mylan-tacrolimus-capsules-5mg-recall-foreign-tablet-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1057-2020
Cite this page
“Mylan Tacrolimus Capsules 5mg Recall: Foreign Tablet Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37289-mylan-tacrolimus-capsules-5mg-recall-foreign-tablet-risk. Based on FDA recall #D-1057-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1057-2020%22&limit=1).
Why it’s dangerous
The capsules may contain a 1mg tablet instead of the intended 5mg. If taken without knowing the actual strength, it could lead to incorrect dosing and potential health issues.
Who’s affected
People with a prescription for Tacrolimus 5mg capsules who received the recalled lot numbers (3105410 or 3106268) from Mylan. Those with higher doses or different formulations are not affected.
How to tell if you have this one
Check the bottle label for 'Tacrolimus Capsules, USP 5mg, 100-count' and lot numbers 3105410 or 3106268. The expiration date is September 2020.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Capsule Label
Look for the lot numbers 3105410 or 3106268 on the bottle.
Contact Your Doctor
If you have the recalled lot numbers, talk to your doctor about possible incorrect dosing.
Questions people ask
Is this recall for all Tacrolimus capsules?
No, only the specific 5mg bottles with lot numbers 3105410 or 3106268.
What should I do if I have the recalled capsules?
Check the label for the lot numbers; if you have them, contact your doctor about possible incorrect dosing.
Are there any safety risks if I take the recalled capsules?
The risk is incorrect dosing due to potential foreign tablets, which could lead to health issues if not addressed.
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-1057-2020 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-1057-2020 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-1057-2020 (March 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1057-2020 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.