FDA Drug Regulatory Intelligence

Xylocaine (lidocaine HCl Injection, USP), 1% recall — Fresenius Kabi Usa, LLC (Class II)

Fresenius Kabi Usa, LLC is recorded by the U.S. Food and Drug Administration (FDA) as recalling Xylocaine (lidocaine HCl Injection, USP), 1% — a Class II recall, initiated 2026-07-16 and posted to the FDA enforcement report on 2026-07-29, under recall number D-0729-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “Presence of Particulate Matter: Hair was found in products”. From the product description, the form is injection, the strengths given are 1%, 500 mg, 50 mL and 10 mg, the package is described as 25 Multiple-Dose Vials and it is marked Rx only. 2 National Drug Code numbers are printed in the record: 63323-485-57 and 63323-485-03. Distribution is recorded as “Nationwide within in the USA” — Nationwide (US), with the recalling firm on record in IL, United States. The FDA files it under event ID 99449 together with 4 other recall numbers, all listed and linked below. Within that event this is the strength 1% · 500 mg · 50 mL · 10 mg, package 25 Multiple-Dose Vials and ndc 63323-485-57 · 63323-485-03 configuration; the sibling records differ on strength, package, ndc and product named, and 1 more and match on everything else the source states. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.

Regulatory snapshot

Recall number D-0729-2026
FDA event ID 99449 (5 recall numbers)
Classification Class II (intermediate regulatory tier)
Status Ongoing
Recalling firm Fresenius Kabi Usa, LLC
Recall initiated 2026-07-16
Reported by FDA 2026-07-29
Report lag 13 days from initiation to report
Distribution Nationwide within in the USA — Nationwide (US)
Firm location on record IL, United States
Product description (source) Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03

Reason reported by FDA

Presence of Particulate Matter: Hair was found in products

9 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

9 identifying values matched by exact pattern in the 35-word product description above; each is a literal substring of it.

Product named Xylocaine (lidocaine HCl Injection, USP)
Form Injection
Strength 1% · 500 mg · 50 mL · 10 mg
Package 25 Multiple-Dose Vials
NDC Tray: 63323-485-57 · Vial: 63323-485-03
Marketing category Rx only

Which configuration this record is

5 recall numbers share event 99449. They differ on strength, package, ndc, product named and reason text and agree on everything else the source states, so those are the values to check a package against.

Attribute This record (D-0729-2026) D-0725-2026D-0726-2026D-0727-2026D-0728-2026
Strength 1% · 500 mg · 50 mL · 10 mg 1 mg · 5 mL · 0.2 mg · 6.5 mL2% · 100 mg · 5 mL · 20 mg0.5% · 100 mg · 20 mL · 5 mg1% · 200 mg · 20 mL · 10 mg
Package 25 Multiple-Dose Vials 6.5 mL vial25 Single Dose Vials—25 Multiple-Dose Vials
NDC 63323-485-57 · 63323-485-03 63323-578-05 · 63323-578-0763323-208-05 · 63323-208-0163323-286-23 · 63323-286-0563323-485-27 · 63323-485-01
Product named Xylocaine (lidocaine HCl Injection, USP) Glycopyrrolate InjectionLidocaine HCl InjectionNaropin (ropivacaine hydrochloride Injection, USP)Xylocaine (lidocaine HCl Injection, USP)
Reason text Presence of Particulate Matter: Hair was found in products Presence of Particulate Matter: Hair was found in productPresence of Particulate Matter: Hair was found in productsPresence of Particulate Matter: Hair was found in productsPresence of Particulate Matter: Hair was found in products

Shared across all 5 records under this event: form Injection; fda tier Class II; recalling firm Fresenius Kabi Usa, LLC; initiated 2026-07-16; reported 2026-07-29.

Event context: 5 recall numbers under event 99449

One enforcement action, 5 recall numbers: the FDA filed 4 further configurations of this action under event 99449. Each keeps its own recall number and dates.

Recall recordRecall numberFDA tierStrength / formNDCReported
Glycopyrrolate Injection, 1 mgD-0725-2026Class II1 mg · Injection63323-578-052026-07-29
Lidocaine HCl Injection, 2%D-0726-2026Class II2% · Injection63323-208-052026-07-29
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%D-0727-2026Class II0.5% · Injection63323-286-232026-07-29
Xylocaine (lidocaine HCl Injection, USP), 1%D-0728-2026Class II1% · Injection63323-485-272026-07-29

Other indexed recalls from Fresenius Kabi Usa, LLC

6 indexed records name Fresenius Kabi Usa, LLC as the recalling firm, across 2 FDA events, reported 2026-06-17 to 2026-07-29. A coverage-limited activity count over the ingested window, not a quality rating.

Recall recordRecall numberFDA tierStrength / formReported
Epinephrine Injection, 1mg/mLD-0581-2026Class III1mg/mL · Injection2026-06-17

Reported in the same month (2026-07)

111 enforcement reports carry a report date in 2026-07; these 8 are the Class II ones nearest this record.

Recall recordRecall numberRecalling firmFDA tierReported
Levothyroxine Sodium Tablets, 25 mcgD-0700-2026Major PharmaceuticalsClass II2026-07-29
Levothyroxine Sodium Tablets, 50 mcgD-0701-2026Major PharmaceuticalsClass II2026-07-29
Levothyroxine Sodium Tablets, 75 mcgD-0702-2026Major PharmaceuticalsClass II2026-07-29
Levothyroxine Sodium Tablets, 88 mcgD-0703-2026Major PharmaceuticalsClass II2026-07-29
Levothyroxine Sodium Tablets, 112 mcgD-0704-2026Major PharmaceuticalsClass II2026-07-29
Levothyroxine Sodium Tablets, 125 mcgD-0705-2026Major PharmaceuticalsClass II2026-07-29
Levothyroxine Sodium Tablets, 150 mcgD-0706-2026Major PharmaceuticalsClass II2026-07-29
Levothyroxine Sodium Tablets, 25 mcgD-0707-2026Major PharmaceuticalsClass II2026-07-29

Nearest Class II recalls by date

213 of 250 indexed records share the Class II tier; the 3 nearest to 2026-07-29 by report date are listed here.

Recall recordRecall numberRecalling firmStrength / formReported
Levothyroxine Sodium Tablets, 50 mcgD-0708-2026Major Pharmaceuticals50 mcg · Tablets2026-07-29
Levothyroxine Sodium Tablets, 75 mcgD-0709-2026Major Pharmaceuticals75 mcg · Tablets2026-07-29
Levothyroxine Sodium Tablets, 125 mcgD-0710-2026Major Pharmaceuticals125 mcg · Tablets2026-07-29

Reading this record

Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 99449 returns all 5 of these recall numbers; a search on D-0729-2026 returns only this configuration. Match a package against 63323-485-57 (Tray) and 63323-485-03 (Vial) at the FDA source to confirm it is covered.

Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Fresenius Kabi Usa, LLC (6 indexed records) aggregates this firm across datasets.

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0729-2026 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-0729-2026%22
Source dataset
openFDA Drug Enforcement API
Publication date
2026-07-29
Ingested
2026-08-22
Record hash
0602f8f738ab7f32

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