Mylan Institutional LLCdrugHigh PriorityActive

Haloperidol Lactate Recall

Haloperidol Lactate Injection has been recalled due to labeling: not elsewhere classified:incorrect rfid tag labels applied to product by repackaging firm.. This recall primarily affects healthcare facilities, hospitals, and pharmacies. Individual consumers are unlikely to have this product at home. Check the official FDA notice for specific lot numbers and return or disposal instructions.

By RecallRadar Editorial Team

Sourced from FDA. Last verified March 4, 2026.

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Key facts

Date announced: October 10, 2025
Source agency: FDA

This recall involves safety concerns. Take action promptly.

✨ Plain-English Summary

Is This Recall Still Active?

Status: Yes - Active

This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.

What's Being Recalled

Quoted source excerpt from the official notice.

Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

Quick Info

Key facts from the official notice, kept in the article flow for easy cross-checking.

Brand: Mylan institutional llc
Category: drug
Source agency: FDA
Announced: October 10, 2025
Country: US
Status: Active

Who's Affected

Specific models and identifiers listed in the source notice:

Model #1

Lot 25381993 and 25391516, Exp 12/31/2026

#	Model
1	Lot 25381993 and 25391516, Exp 12/31/2026

Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.

What You Should Do

Follow the remedy path from the official notice using the exact model and serial details above.

1## Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV
2NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with Agency: FDA | Category: drug Reason: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. What to do:
3Stop using the product if your lot/model matches.
4Check the FDA notice for specifics.

Open Official Recall Notice

Source & Verification

This page summarizes the official notice and keeps key facts easy to verify.

Official source: FDA
Announced by source: October 10, 2025
Last reviewed by RecallRadar: March 4, 2026

Frequently Asked Questions

Am I affected by this recall?

Check the affected models section on this page. The official notice currently lists Lot 25381993 and 25391516, Exp 12/31/2026.

What is the remedy for this recall?

## Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intramuscular Use Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26605. NDC: 67457-426-12 with Safecor Health LLC KITCHECK RFID Tag attached with Agency: FDA | Category: drug Reason: Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.

Where can I verify recall details?

Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Keep browsing with these internal hubs: Mylan Institutional LLC recall hub and Food & Drug recall hub.