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Drug recall · FDA · Published May 3, 2021

Mylan Institutional LLC recalls Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx

Mylan recalls Thiamine HCl injection vials with incorrect lot numbers. This affects 25-vial cartons labeled with lot 200901 instead of 200906. No immediate action needed but verify labels.

🇺🇸 FDA recall #D-0601-2021DrugMylan ›
Take action

Contact the company & request your remedy

Recalling firmMylan Institutional LLC4901 Hiawatha Dr · Rockford, IL 61103-1287
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 Thiamine HCl injection vials that have incorrect lot numbers on the carton. This could lead to confusion in tracking expiration dates and lot numbers, but it does not pose a direct safety risk to users. Read more at govinfonow.com/recall/36158-mylan-thiamine-hcl-injection-recall-incorrect-lot-exp-dates.

Source Summary by GovInfoNow · govinfonow.com/recall/36158-mylan-thiamine-hcl-injection-recall-incorrect-lot-exp-dates · Updated October 4, 2026 · FDA enforcement record: FDA #D-0601-2021

Cite this page

“Mylan Thiamine HCl Injection Recall: Incorrect Lot/Exp Dates.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36158-mylan-thiamine-hcl-injection-recall-incorrect-lot-exp-dates. Based on FDA recall #D-0601-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0601-2021%22&limit=1).

Why it’s dangerous

The cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901. This labeling error means the expiration date and lot number might be misinterpreted, potentially causing confusion in tracking the product's shelf life and batch.

Who’s affected

Healthcare professionals who use Thiamine HCl injections for medical purposes. Patients receiving these injections under a prescription are not directly affected by this labeling issue.

How to tell if you have this one

Check for cartons labeled with lot number 200901 instead of 200906. The product is a 25-vial carton of Thiamine HCl injection vials (2 mL each) with NDC 67457-196-02.

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

What to do — step by step

  1. Verify Label

    Check the carton for the lot number 200901 instead of 200906. If found, do not use the product.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The product is safe to use if the lot number matches the carton label. This recall is for labeling errors, not safety issues.

How can I check if I have the recalled product?

Look for cartons labeled with lot number 200901 instead of 200906. The product is a 25-vial carton of Thiamine HCl injection vials (2 mL each) with NDC 67457-196-02.

Do I need to return the product?

No return is required. The recall is for labeling correction, not product disposal.

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-0601-2021 — Mylan Mylan

Hello,

I own a Mylan that is covered by recall D-0601-2021 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-0601-2021 (May 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0601-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on October 4, 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