Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-u...
FDA Drug Recall #D-0152-2018 — Class I — October 27, 2017
Recall Summary
| Recall Number | D-0152-2018 |
| Classification | Class I — Serious risk |
| Date Initiated | October 27, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Fresenius Kabi USA, LLC |
| Location | Wilson, NC |
| Product Type | Drugs |
| Quantity | 203136 syringes |
Product Description
Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20
Reason for Recall
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
Distribution Pattern
Nationwide in the USA
Lot / Code Information
Lot: 6400048
Other Recalls from Fresenius Kabi USA, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0182-2026 | Class I | Famotidine Injection, USP, 20 mg per 2 mL (10 m... | Nov 6, 2025 |
| D-0127-2023 | Class II | Sensorcaine (Bupivacaine HCl and Epinephrine In... | Nov 22, 2022 |
| D-0128-2023 | Class II | Sensorcaine (Bupivacaine HCl and Epinephrine In... | Nov 22, 2022 |
| D-0129-2023 | Class II | Sensorcaine-MPF (Bupivacaine HCl and Epinephrin... | Nov 22, 2022 |
| D-0750-2022 | Class I | Sodium Acetate Injection, USP, 400 mEq / 100 mL... | Mar 4, 2022 |
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.