Fresenius Kabi Usa, LLC: FDA regulatory profile
Fresenius Kabi Usa, LLC appears in 6 indexed U.S. FDA records: 6 recall records, naming 6 distinct products. Latest dated event: a recall record dated 2026-07-29. Observations run 2026-06-17 to 2026-07-29 — 42 days, 6 dated records across 1 calendar year, busiest 2026 with 6. Recalls: 5 Class II (83%) and 1 Class III (17%); 6 ongoing by lifecycle status, reported 2026-06-17 to 2026-07-29; 6 with an FDA recall number, 6 with an initiation date, across 1 state, grouped into 2 FDA recall events. Every figure here is a count or a date computed from the indexed FDA datasets over a finite window: coverage-limited activity signals, never quality ratings or judgements about the firm. Recall records: Glycopyrrolate Injection (D-0725-2026, Class II, 2026-07-29), Lidocaine HCl Injection (D-0726-2026, Class II, 2026-07-29), Naropin (ropivacaine hydrochloride Injection (D-0727-2026, Class II, 2026-07-29) and Xylocaine (lidocaine HCl Injection (D-0728-2026, Class II, 2026-07-29). Recalling-firm addresses are recorded in IL. Its recall lines are grouped by the FDA into 2 event identifiers: 98997 and 99449.
Regulatory snapshot
| Indexed records | 6 |
|---|---|
| Recall records | 6 |
| Shortage entries | 0 |
| Source rows filed | 0 |
| Approval records | 0 |
| Current shortages | 0 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 6 |
| Recall classifications | Class II: 5 · Class III: 1 |
| Recall statuses | Ongoing: 6 |
| First observed | 2026-06-17 |
| Latest observed | 2026-07-29 |
| Latest event type | recall |
| Dated observations | 6 |
| Years covered | 1 |
| Span (days) | 42 |
| Busiest year | 2026 (6 records) |
| Recall states | 1 |
| With recall number | 6 of 6 |
| FDA recall events | 2 |
| Related firms / shortages | 0 / 0 |
Counts, not a rating. Coverage-limited activity signals over the ingested window — never reputational scores or judgements about the firm or its products.
Record breakdown
| Dimension | Value | Records | Share |
|---|---|---|---|
| Recall classification | Class II | 5 | 83% |
| Recall classification | Class III | 1 | 17% |
| Recall status | Ongoing | 6 | 100% |
Recall history (6)
Every enforcement report attributed to this firm, newest first. Classification is the FDA's severity tier, status its lifecycle position — neither is a safety statement.
| Product (as published) | Recall number | Classification | Status | Reported | Initiated |
|---|---|---|---|---|---|
| Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL v | D-0725-2026 | Class II | Ongoing | 2026-07-29 | 2026-07-16 |
| Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 | D-0726-2026 | Class II | Ongoing | 2026-07-29 | 2026-07-16 |
| Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), | D-0727-2026 | Class II | Ongoing | 2026-07-29 | 2026-07-16 |
| Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple | D-0728-2026 | Class II | Ongoing | 2026-07-29 | 2026-07-16 |
| Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple | D-0729-2026 | Class II | Ongoing | 2026-07-29 | 2026-07-16 |
| Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Z | D-0581-2026 | Class III | Ongoing | 2026-06-17 | 2026-05-14 |
| FDA recall event | Records | Classification(s) | First reported | Last reported |
|---|---|---|---|---|
| 99449 | 5 | Class II | 2026-07-29 | 2026-07-29 |
| 98997 | 1 | Class III | 2026-06-17 | 2026-06-17 |
Browse the wider classification index: Class II recalls · Class III recalls.
Products and drugs named (6)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fr | recall | 1 | 2026-06-17 |
| Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 m | recall | 1 | 2026-07-29 |
| Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 S | recall | 1 | 2026-07-29 |
| Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 2 | recall | 1 | 2026-07-29 |
| Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg | recall | 1 | 2026-07-29 |
| Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg | recall | 1 | 2026-07-29 |
Source limitations
Built from the 6 ingested FDA records for this firm (6 recall, 0 shortage, 0 approval) — not its full regulatory history. The window is finite and can lag the live record, and alternate spellings of a firm name may sit under separate profiles. Confirm details at the linked official source. Regulatory information only: no safety assessment, no recommendation.
How to read these records
Where to go next
Source & provenance
- Official source
- https://open.fda.gov/apis/drug/enforcement/
- Source dataset
- openFDA (enforcement + shortages + Drugs@FDA)
- Publication date
- Not available
- Ingested
- 2026-08-22
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.