Lidocaine HCl Injection, 2% recall — Eugia US LLC (Class III)

Eugia US LLC is recorded by the U.S. Food and Drug Administration (FDA) as recalling Lidocaine HCl Injection, 2% — a Class III recall, initiated 2026-05-18 and posted to the FDA enforcement report on 2026-06-10, under recall number D-0552-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan”. From the product description, the form is injection, the strengths given are 2%, 40 mg/2 mL, 20 mg/mL and 2 mL and it is marked Rx only. 1 National Drug Code number is printed in the record: 55150-164-02. Distribution is recorded as “US Nationwide” — Nationwide (US), with the recalling firm on record in NJ, United States. It is the only recall number the FDA has filed under event ID 99024. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.

Regulatory snapshot

Recall number D-0552-2026
FDA event ID 99024
Classification Class III (least serious regulatory tier)
Status Ongoing
Recalling firm Eugia US LLC
Recall initiated 2026-05-18
Reported by FDA 2026-06-10
Report lag 23 days from initiation to report
Distribution US Nationwide. — Nationwide (US)
Firm location on record NJ, United States
Product description (source) 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 reported by FDA

Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

15 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

7 identifying values matched by exact pattern in the 30-word product description above; each is a literal substring of it.

Product named Lidocaine HCl Injection
Form Injection
Strength 2% · 40 mg/2 mL · 20 mg/mL · 2 mL
NDC 55150-164-02
Marketing category Rx only

Other indexed recalls of lidocaine hydrochloride

4 indexed records name lidocaine hydrochloride as the recalled substance. Matching is on the product-name prefix of the FDA's own text, so other strengths and packages are included.

Recall recordRecall numberRecalling firmStrength / formReported
Lidocaine HCl Injection, 2%D-0726-2026Fresenius Kabi Usa, LLC2% · Injection2026-07-29
Lidocaine HCl Injection USP, 1%D-0659-2026Asclemed Usa Inc.1% · Injection2026-07-08
Lidocaine HCl Injection USPD-0554-2026Spectra Medical Devices, LLCInjection2026-06-10

Reported in the same month (2026-06)

74 enforcement reports carry a report date in 2026-06; these 5 are the Class III ones nearest this record.

Recall recordRecall numberRecalling firmFDA tierReported
Nicotine Transdermal System Patch, 14 mgD-0550-2026Aveva Drug Delivery Systems, Inc.Class III2026-06-03
PRED MILD, 0.12%D-0551-2026Abbvie Inc.Class III2026-06-03
Epinephrine Injection, 1mg/mLD-0581-2026Fresenius Kabi Usa, LLCClass III2026-06-17
Primidone Tablets, 50 mgD-0585-2026Amneal Pharmaceuticals, LLCClass III2026-06-17
Focalin XR (dexmethylphenidate HCl) 5 mgD-0608-2026Sandoz IncClass III2026-06-24

Nearest Class III recalls by date

25 of 250 indexed records share the Class III tier; the 8 nearest to 2026-06-10 by report date are listed here.

Recall recordRecall numberRecalling firmStrength / formReported
Primidone Tablets USP, 250mgD-0533-2026Lannett Company Inc.250mg · Tablets2026-05-27
Primidone Tablets, 50 mgD-0534-2026Golden State Medical Supply Inc.50 mg · Tablets2026-05-27
Primidone Tablets, 250 mgD-0535-2026Golden State Medical Supply Inc.250 mg · Tablets2026-05-27
Primidone Tablets, 250 mgD-0536-2026Amerisource Health Services LLC250 mg · Tablets2026-05-27
Primidone Tablets, 50 mgD-0537-2026Amerisource Health Services LLC50 mg · Tablets2026-05-27
Busulfan Injection, 60 mgD-0539-2026Sagent Pharmaceuticals60 mg · Injection2026-05-27
hydrOXYzine Hydrochloride Oral Solution, 10 mg/5 mLD-0619-2026Ani Pharmaceuticals, Inc.10 mg/5 mL · Oral Solution2026-07-01
busPIRone Hydrochloride Tablets, 5 mgD-0511-2026Unichem Pharmaceuticals Usa Inc.5 mg · Tablets2026-05-13

Reading this record

Class III is the FDA's own severity tier for the recall action — 25 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. Match a package against 55150-164-02 at the FDA source to confirm it is covered.

Namespace context: the Class III index (25 records) and the recall hub (250 records, 118 FDA events); Eugia US LLC (1 indexed records) aggregates this firm across datasets.

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0552-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.

Source & provenance

Official source
https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0552-2026%22
Source dataset
openFDA Drug Enforcement API
Publication date
2026-06-10
Ingested
2026-08-22
Record hash
d78c7e72f656474a

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.