Baxter Healthcare: FDA regulatory profile
Baxter Healthcare appears in 14 indexed U.S. FDA records: 14 drug-shortage entries (from 36 openFDA source rows), naming 14 distinct products. Latest dated event: a shortage record dated 2026-08-20. Observations run 2012-02-22 to 2026-08-20 — 5293 days, 28 dated records across 7 calendar years, busiest 2026 with 15. Shortages: 14 current, averaging 2.6 package lines each across 11 FDA therapeutic categories, 22 strengths, 168 package NDCs and 18 brand names. 6 related firms and 8 adjacent shortage entries are linked below, each by a shared shortage entry, substance or therapeutic category. 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. By year: 2026 (15), 2023 (3), 2022 (2), 2020 (3), 2018 (1), 2017 (3), 2012 (1). Shortage entries include Dexmedetomidine Hydrochloride Injection (Current, since 2020-04-10, 4 lines), Rocuronium Bromide Injection (Current, since 2023-02-15, 1 lines), Clindamycin Phosphate Injection (Current, since 2023-03-21, 2 lines) and Furosemide Injection (Current, since 2020-04-07, 2 lines).
Regulatory snapshot
| Indexed records | 14 |
|---|---|
| Recall records | 0 |
| Shortage entries | 14 |
| Source rows filed | 36 |
| Approval records | 0 |
| Current shortages | 14 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 14 |
| Recall classifications | 0 |
| Recall statuses | 0 |
| First observed | 2012-02-22 |
| Latest observed | 2026-08-20 |
| Latest event type | shortage |
| Dated observations | 28 |
| Years covered | 7 |
| Span (days) | 5293 |
| Busiest year | 2026 (15 records) |
| Lines per entry (mean) | 2.6 |
| Therapeutic categories | 11 |
| Distinct strengths | 22 |
| Package NDCs | 168 |
| Brand names | 18 |
| Related firms / shortages | 6 / 8 |
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 |
|---|---|---|---|
| Shortage status | Current | 14 | 100% |
| Therapeutic category | Pediatric | 6 | 43% |
| Therapeutic category | Cardiovascular | 4 | 29% |
| Therapeutic category | Gastroenterology | 4 | 29% |
| Therapeutic category | Anesthesia | 3 | 21% |
| Therapeutic category | Other | 3 | 21% |
| Therapeutic category | Endocrinology/Metabolism | 2 | 14% |
| Therapeutic category | Analgesia/Addiction | 1 | 7% |
| Therapeutic category | Anti-Infective | 1 | 7% |
| Therapeutic category | Hematology | 1 | 7% |
| Therapeutic category | Oncology | 1 | 7% |
| Therapeutic category | Renal | 1 | 7% |
Current shortages (14)
Reported by this firm and recorded by the FDA as active. Each links to its canonical entry.
| Shortage | Status | Since | Updated | Lines filed | Presentations | Strengths |
|---|---|---|---|---|---|---|
| Dexmedetomidine Hydrochloride Injection (Dexmedetomidine IN Dextrose, Precedex) | Current | 2020-04-10 | 2026-08-20 | 4 | 4 | 200 ug/50 mL, 400 ug/100 mL |
| Rocuronium Bromide Injection | Current | 2023-02-15 | 2026-08-20 | 1 | 1 | 50 mg/5 mL |
| Clindamycin Phosphate Injection (Cleocin) | Current | 2023-03-21 | 2026-08-18 | 2 | 2 | 300 mg/50 mL, 600 mg/50 mL |
| Furosemide Injection | Current | 2020-04-07 | 2026-08-18 | 2 | 2 | 10 mg/1 mL |
| Ketorolac Tromethamine Injection | Current | 2018-03-26 | 2026-08-18 | 2 | 2 | 15 mg/1 mL, 30 mg/1 mL |
| Lidocaine Hydrochloride Injection (Lidocaine Hydrochloride And Dextrose) | Current | 2012-02-22 | 2026-08-18 | 1 | 1 | 8 mg/1 mL |
| Amino Acid Injection (Aminosyn II, Aminosyn II 10 %, Aminosyn II 15%, Clinisol, Clinisol 15, Plenamine, Premasol, Premasol - Sulfite-free (amino Acid), Travasol, Travasol 10) | Current | 2020-12-08 | 2026-08-17 | 5 | 5 | 0.1, 0.15, 2.07 g/100 mL; 1.15 g/100 mL; 1.03 g/100 mL; 480 mg/100 mL; 600 mg/100 mL; 730 mg/100 mL; 580 mg/100 mL; 400 mg/100 mL; 560 mg/100 mL; 680 mg/100 mL; 500 mg/100 mL; 420 mg/100 mL; 180 mg/100 mL; 40 mg/100 mL; 580 mg/100 mL |
| Dextrose Monohydrate 10% Injection | Current | 2022-03-01 | 2026-08-17 | 3 | 3 | 100 g/1000 mL |
| Dextrose Monohydrate 5% Injection | Current | 2022-02-14 | 2026-08-17 | 10 | 10 | 2.5 g/50 mL, 5 g/100 mL, 50 g/1000 mL |
| Dobutamine Hydrochloride Injection (Dobutamine Hydrochloride IN Dextrose) | Current | 2017-11-06 | 2026-08-17 | 1 | 1 | 400 mg/100 mL |
| Dopamine Hydrochloride Injection (Dopamine Hydrochloride And Dextrose) | Current | 2017-11-06 | 2026-08-17 | 2 | 2 | 160 mg/100 mL, 80 mg/100 mL |
| Heparin Sodium Injection (Heparin Sodium IN Sodium Chloride) | Current | 2017-11-14 | 2026-08-17 | 1 | 1 | 200 [USP'U]/100 mL |
| Ifosfamide Injection (Ifex) | Current | 2026-06-12 | 2026-08-17 | 1 | 1 | 3 g/60 mL |
| Sterile Water Irrigant | Current | 2023-04-28 | 2026-08-17 | 1 | 1 | 100 mL/100 mL |
Package lines filed (36)
The openFDA shortage lines this firm filed, with the agency's own availability text. First 30 of 36.
| Shortage | Presentation | Strength | Package NDC | Status | Availability (FDA text) | Updated |
|---|---|---|---|---|---|---|
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 0338-9557-12) | 400 ug/100 mL | 0338-9557-12 | Current | Available | 2026-08-17 |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 400 ug/100 mL (NDC 43066-557-12) | 400 ug/100 mL | 43066-557-12 | Current | Available | 2026-08-17 |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 43066-555-24) | 200 ug/50 mL | 43066-555-24 | Current | Available | 2026-08-17 |
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 200 ug/50 mL (NDC 0338-9555-24) | 200 ug/50 mL | 0338-9555-24 | Current | Unavailable | 2026-08-17 |
| Rocuronium Bromide Injection | Rocuronium Bromide, Injection, 50 mg/5 mL (NDC 43066-007-10) | 50 mg/5 mL | 43066-007-10 | Current | Available | 2026-08-17 |
| Clindamycin Phosphate Injection | Clindamycin Phosphate, Injection, 300 mg/50 mL (NDC 0338-9545-50) | 300 mg/50 mL | 0338-9545-50 | Current | Available | 2026-08-17 |
| Clindamycin Phosphate Injection | Clindamycin Phosphate, Injection, 600 mg/50 mL (NDC 0338-3612-50) | 600 mg/50 mL | 0338-3612-50 | Current | Unavailable | 2026-08-17 |
| Furosemide Injection | Furosemide, Injection, 10 mg/1 mL (NDC 36000-283-25) | 10 mg/1 mL | 36000-283-25 | Current | Available | 2026-08-17 |
| Furosemide Injection | Furosemide, Injection, 10 mg/1 mL (NDC 36000-284-25) | 10 mg/1 mL | 36000-284-25 | Current | Available | 2026-08-17 |
| Ketorolac Tromethamine Injection | Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 0338-0069-10) | 15 mg/1 mL | 0338-0069-10 | Current | Unavailable | 2026-08-17 |
| Ketorolac Tromethamine Injection | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 0338-0072-25) | 30 mg/1 mL | 0338-0072-25 | Current | Unavailable | 2026-08-17 |
| Lidocaine Hydrochloride Injection | Lidocaine Hydrochloride And Dextrose, Injection, 8 mg/1 mL (NDC 0338-0411-02) | 8 mg/1 mL | 0338-0411-02 | Current | Available | 2026-08-17 |
| Amino Acid Injection | Premasol 10% Sulfite Free in VIAFLEX Plastic Container, Injection, 0.1 (NDC 0338-1130-04) | 0.1 | 0338-1130-04 | Current | Available | 2026-08-17 |
| Amino Acid Injection | Premasol 10% Sulfite Free in VIAFLEX Plastic Container, Injection, 0.1 (NDC 0338-1130-06) | 0.1 | 0338-1130-06 | Current | Available | 2026-08-17 |
| Amino Acid Injection | Travasol, Injection, 2.07 g/100 mL; 1.15 g/100 mL; 1.03 g/100 mL; 480 mg/100 mL; 600 mg/100 mL; 730 mg/100 mL; 580 mg/100 mL; 400 mg/100 mL; 560 mg/100 mL; 680 mg/100 mL; 500 mg/100 mL; 420 mg/100 mL; 180 mg/100 mL; 40 mg/100 mL; 580 mg/100 mL (NDC 0338-0644-03) | 2.07 g/100 mL; 1.15 g/100 mL; 1.03 g/100 mL; 480 mg/100 mL; 600 mg/100 mL; 730 mg/100 mL; 580 mg/100 mL; 400 mg/100 mL; 560 mg/100 mL; 680 mg/100 mL; 500 mg/100 mL; 420 mg/100 mL; 180 mg/100 mL; 40 mg/100 mL; 580 mg/100 mL | 0338-0644-03 | Current | Unavailable | 2026-08-17 |
| Amino Acid Injection | Clinisol 15% Sulfite Free In Plastic Container, Injection, 0.15 (NDC 0338-0502-06) | 0.15 | 0338-0502-06 | Current | Available | 2026-08-17 |
| Amino Acid Injection | Clinisol 15% Sulfite Free In Plastic Container, Injection, 0.15 (NDC 0338-0502-03) | 0.15 | 0338-0502-03 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 10% Injection | Dextrose 10% In Plastic Container, Injection, 100 g/1000 mL (NDC 0338-0023-04) | 100 g/1000 mL | 0338-0023-04 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 10% Injection | Dextrose 10% In Plastic Container, Injection, 100 g/1000 mL (NDC 0338-0023-03) | 100 g/1000 mL | 0338-0023-03 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 10% Injection | Dextrose 10% In Plastic Container, Injection, 100 g/1000 mL (NDC 0338-0023-02) | 100 g/1000 mL | 0338-0023-02 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 5 g/100 mL (NDC 0338-0551-18) | 5 g/100 mL | 0338-0551-18 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 50 g/1000 mL (NDC 0338-0017-03) | 50 g/1000 mL | 0338-0017-03 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 5 g/100 mL (NDC 0338-9666-35) | 5 g/100 mL | 0338-9666-35 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 5 g/100 mL (NDC 0338-0078-20) | 5 g/100 mL | 0338-0078-20 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 5 g/100 mL (NDC 0338-0551-11) | 5 g/100 mL | 0338-0551-11 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 5 g/100 mL (NDC 0338-0074-30) | 5 g/100 mL | 0338-0074-30 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 50 g/1000 mL (NDC 0338-0017-48) | 50 g/1000 mL | 0338-0017-48 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 50 g/1000 mL (NDC 0338-0017-10) | 50 g/1000 mL | 0338-0017-10 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 2.5 g/50 mL (NDC 0338-9664-40) | 2.5 g/50 mL | 0338-9664-40 | Current | Available | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | Dextrose 5% In Plastic Container, Injection, 50 g/1000 mL (NDC 0338-0017-38) | 50 g/1000 mL | 0338-0017-38 | Current | Available | 2026-08-17 |
Products and drugs named (14)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Amino Acid Injection | shortage | 5 | 2026-08-17 |
| Clindamycin Phosphate Injection | shortage | 2 | 2026-08-18 |
| Dexmedetomidine Hydrochloride Injection | shortage | 4 | 2026-08-20 |
| Dextrose Monohydrate 10% Injection | shortage | 3 | 2026-08-17 |
| Dextrose Monohydrate 5% Injection | shortage | 10 | 2026-08-17 |
| Dobutamine Hydrochloride Injection | shortage | 1 | 2026-08-17 |
| Dopamine Hydrochloride Injection | shortage | 2 | 2026-08-17 |
| Furosemide Injection | shortage | 2 | 2026-08-18 |
| Heparin Sodium Injection | shortage | 1 | 2026-08-17 |
| Ifosfamide Injection | shortage | 1 | 2026-08-17 |
| Ketorolac Tromethamine Injection | shortage | 2 | 2026-08-18 |
| Lidocaine Hydrochloride Injection | shortage | 1 | 2026-08-18 |
| Rocuronium Bromide Injection | shortage | 1 | 2026-08-20 |
| Sterile Water Irrigant | shortage | 1 | 2026-08-17 |
Indexed activity by year
Counts within the ingested window across 28 dated records — not a trend.
| Year | Recalls | Shortage observations | Approvals | Total |
|---|---|---|---|---|
| 2026 | 0 | 15 | 0 | 15 |
| 2023 | 0 | 3 | 0 | 3 |
| 2022 | 0 | 2 | 0 | 2 |
| 2020 | 0 | 3 | 0 | 3 |
| 2018 | 0 | 1 | 0 | 1 |
| 2017 | 0 | 3 | 0 | 3 |
| 2012 | 0 | 1 | 0 | 1 |
Related manufacturers
Linked by a co-reported shortage entry or a shortage of the same active substance — never inferred from name or sector.
| Firm | Relation | Records | Recalls | Shortages | Latest |
|---|---|---|---|---|---|
| Amphastar Pharmaceuticals, Inc. | co-reports the same shortage; reports a shortage of the same substance | 6 | 0 | 6 | 2026-08-18 |
| Otsuka Icu Medical LLC | co-reports the same shortage; reports a shortage of the same substance | 5 | 0 | 5 | 2026-08-17 |
| Accord Healthcare, Inc. | co-reports the same shortage | 7 | 1 | 6 | 2026-08-20 |
| Avet Pharmaceuticals, Inc. | co-reports the same shortage | 2 | 0 | 2 | 2026-08-18 |
| Azurity Pharmaceuticals, Inc | co-reports the same shortage | 1 | 0 | 1 | 2026-08-20 |
| HQ Specialty Pharma | co-reports the same shortage | 1 | 0 | 1 | 2026-08-20 |
Related shortages in this firm's areas
Not reported by this firm, but sharing a substance identifier or therapeutic category with one that is.
| Shortage | Status | Relation | Since | Updated | Presentations | Firms |
|---|---|---|---|---|---|---|
| Dexamethasone Sodium Phosphate Injection | Current | same therapeutic category | 2019-02-08 | 2026-08-20 | 4 | 1 |
| Sodium Bicarbonate Injection | Current | same therapeutic category | 2017-03-01 | 2026-08-18 | 2 | 2 |
| Dextrose Monohydrate 70% Injection | Current | same therapeutic category | 2024-10-11 | 2026-08-17 | 1 | 1 |
| Dextrose Monohydrate 50% Injection | Current | same therapeutic category | 2022-01-13 | 2026-08-18 | 1 | 1 |
| Bumetanide Injection | Current | same therapeutic category | 2017-12-13 | 2026-08-21 | 6 | 2 |
| Etomidate Injection | Current | same therapeutic category | 2022-10-05 | 2026-08-20 | 2 | 1 |
| Remifentanil Hydrochloride Injection | Current | same therapeutic category | 2022-06-28 | 2026-08-20 | 3 | 1 |
| Rifampin Injection | Current | same therapeutic category | 2021-02-17 | 2026-08-20 | 1 | 1 |
Source limitations
Built from the 14 ingested FDA records for this firm (0 recall, 14 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.