Lidocaine HCl Injection recall
FDA recall D-0552-2026 · initiated May 18, 2026
Eugia US LLC recalled Lidocaine HCl Injection in May 2026 — an FDA Class III recall (D-0552-2026) because Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 168,300 vials
Details
- Product
- 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
- Recalling company
- Eugia Pharma
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- May 18, 2026
- FDA report date
- Jun 10, 2026
Frequently asked
- Was Lidocaine HCl Injection recalled?
- Eugia US LLC recalled Lidocaine HCl Injection in May 2026 — an FDA Class III recall (D-0552-2026) because Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Lidocaine HCl Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0552-2026 was: Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
- Is a recalled Lidocaine HCl Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lidocaine HCl Injection are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot, expiry: Lot 3LC26029A, exp Feb-2029; Lot 3LC26031A, exp Mar-2029. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0552-2026.