Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile, Rx only, For Intram...
FDA Drug Recall #D-0214-2026 - Class II, October 10, 2025
Recall Summary
| Recall Number | D-0214-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | October 10, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Safecor Health, LLC |
| Location | Woburn, MA |
| Product Type | Drugs |
| Quantity | 800 1mL vials |
Product Description
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 incorrect serial numbers: KITCHECK 8001-03A3,00000000,003A-2560, and 8001-03A3,00000000,003A-2D3B.
Reason for Recall
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Distribution Pattern
Distributed in Massachusetts
Lot / Code Information
Lot 25381993 and 25391516, Exp 12/31/2026
Other Recalls from Safecor Health, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0549-2026 | Class II | Vitamin B-Complex, Vitamin C & Folic Acid Dieta... | May 1, 2026 |
| D-0538-2026 | Class II | Atomoxetine Capsules HCL, 10 mg Capsules in uni... | Apr 30, 2026 |
| D-0253-2025 | Class II | Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Deli... | Feb 17, 2025 |
| D-0252-2025 | Class II | Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe... | Feb 17, 2025 |
| D-0250-2025 | Class II | Ergocalciferol - Vitamin D Supplement - 10 mcg ... | Feb 17, 2025 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications, even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications, use a drug take-back program.