Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. ...
FDA Drug Recall #D-0552-2026 — Class III — May 18, 2026
Recall Summary
| Recall Number | D-0552-2026 |
| Classification | Class III — Low risk |
| Date Initiated | May 18, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Eugia US LLC |
| Location | East Windsor, NJ |
| Product Type | Drugs |
| Quantity | 168,300 vials |
Product Description
Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02
Reason for Recall
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Distribution Pattern
US Nationwide.
Lot / Code Information
Lot, expiry: Lot 3LC26029A, exp Feb-2029; Lot 3LC26031A, exp Mar-2029
Other Recalls from Eugia US LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0472-2025 | Class II | Gentamicin Injection, USP, (PEDIATRIC), 20 mg p... | May 29, 2025 |
| D-0390-2025 | Class II | Tirofiban Hydrochloride Injection 12.5 mg/250 m... | Apr 21, 2025 |
| D-0389-2025 | Class II | Tirofiban Hydrochloride Injection 5 mg/100 mL (... | Apr 21, 2025 |
| D-0363-2025 | Class II | Testosterone Cypionate Injection, USP, CIII, 20... | Apr 10, 2025 |
| D-0186-2025 | Class II | Progesterone Injection USP, 500mg per 10 mL (50... | Dec 27, 2024 |
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.