Fresenius Kabi Usa, LLC: FDA regulatory signals
This page aggregates the United States FDA regulatory records that reference Fresenius Kabi Usa, LLC in the datasets indexed by this site. Across the ingested data, Fresenius Kabi Usa, LLC is associated with 14 recall record(s), 136 drug-shortage record(s), and 0 approval record(s). The most recent dated event attributed to this firm in the indexed data is a shortage record dated 2026-06-04. These counts are coverage-limited activity signals derived only from the specific FDA datasets indexed here. They are NOT quality ratings, reputational scores, or judgements about the firm or its products. A higher or lower count reflects how often a firm appears in these particular public records over the ingested window — nothing more. Recalls and shortages are routine parts of pharmaceutical regulation, and their presence here is an administrative fact, not an indication of wrongdoing or of product danger. Use this page as a finding aid to locate the underlying FDA records, then verify every detail against the official source. This page contains regulatory information only and offers no medical advice.
Signal summary
| Recall records | 14 |
|---|---|
| Shortage records | 136 |
| Approval records | 0 |
| Most recent record date | 2026-06-04 |
| Most recent record type | shortage |
These counts are not a quality rating. They are coverage-limited activity signals showing how often this firm appears in the indexed FDA recall and shortage records over the ingested window. They are not reputational scores or judgements about the firm or its products.
Recall records
- 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30. · Class II · 2026-04-15
- 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case). · Class II · 2026-04-15
- 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85. · Class II · 2026-04-15
- 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50. · Class II · 2026-04-15
- 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20. · Class II · 2026-04-15
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03. · Class II · 2026-04-15
- 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60. · Class II · 2026-04-15
- 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30. · Class II · 2026-04-15
- 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50. · Class II · 2026-04-15
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10. · Class II · 2026-04-15
Shortage records
- Bupivacaine Hydrochloride Injection · Current · 2026-06-04
- Morphine Sulfate Injection · Current · 2026-06-04
- Epinephrine Bitartrate, Lidocaine Hydrochloride Injection · Current · 2026-06-04
- Remifentanil Hydrochloride Injection · Current · 2026-06-04
- Ropivacaine Hydrochloride Injection · Current · 2026-06-04
- Ropivacaine Hydrochloride Injection · Current · 2026-06-04
- Midazolam Hydrochloride Injection · Current · 2026-06-04
- Bupivacaine Hydrochloride Injection · Current · 2026-06-04
- Ketorolac Tromethamine Injection · Current · 2026-06-04
- Lidocaine Hydrochloride Injection · Current · 2026-06-04
Source limitations
This page is built only from the FDA recall and shortage records this site has ingested. It does not represent the firm's full regulatory history, its approvals, or any data held in sources not indexed here. The ingested window is finite and can lag the live FDA record, so counts and dates reflect a point in time. Every linked record points back to the verifiable official source; confirm details there. This page contains regulatory information only and offers no medical advice, no assessment of product safety, and no recommendation of any kind.
Source & provenance
- Official source
- https://open.fda.gov/apis/drug/enforcement/
- Source dataset
- openFDA (enforcement + shortages)
- Publication date
- Not available
- Ingested
- 2026-06-09
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.