Sagent Pharmaceuticals: FDA regulatory profile
Sagent Pharmaceuticals appears in 6 indexed U.S. FDA records: 1 recall record and 5 drug-shortage entries (from 12 openFDA source rows), naming 6 distinct products. Latest dated event: a shortage record dated 2026-08-21. Observations run 2017-12-13 to 2026-08-21 — 3173 days, 11 dated records across 5 calendar years, busiest 2026 with 6. Recalls: 1 Class III (100%); 1 ongoing by lifecycle status, reported 2026-05-27; 1 with an FDA recall number, 1 with an initiation date, across 1 state, grouped into 1 FDA recall event. Shortages: 5 current, averaging 2.4 package lines each across 5 FDA therapeutic categories, 7 strengths, 53 package NDCs and 2 brand names. 5 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.
Regulatory snapshot
| Indexed records | 6 |
|---|---|
| Recall records | 1 |
| Shortage entries | 5 |
| Source rows filed | 12 |
| Approval records | 0 |
| Current shortages | 5 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 6 |
| Recall classifications | Class III: 1 |
| Recall statuses | Ongoing: 1 |
| First observed | 2017-12-13 |
| Latest observed | 2026-08-21 |
| Latest event type | shortage |
| Dated observations | 11 |
| Years covered | 5 |
| Span (days) | 3173 |
| Busiest year | 2026 (6 records) |
| Lines per entry (mean) | 2.4 |
| Therapeutic categories | 5 |
| Distinct strengths | 7 |
| Package NDCs | 53 |
| Brand names | 2 |
| Recall states | 1 |
| With recall number | 1 of 1 |
| FDA recall events | 1 |
| Related firms / shortages | 5 / 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 |
|---|---|---|---|
| Recall classification | Class III | 1 | 100% |
| Recall status | Ongoing | 1 | 100% |
| Shortage status | Current | 5 | 100% |
| Therapeutic category | Analgesia/Addiction | 1 | 20% |
| Therapeutic category | Anesthesia | 1 | 20% |
| Therapeutic category | Anti-Infective | 1 | 20% |
| Therapeutic category | Cardiovascular | 1 | 20% |
| Therapeutic category | Rheumatology | 1 | 20% |
Current shortages (5)
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 |
|---|---|---|---|---|---|---|
| Bumetanide Injection | Current | 2017-12-13 | 2026-08-21 | 2 | 2 | .25 mg/1 mL |
| Rocuronium Bromide Injection | Current | 2023-02-15 | 2026-08-20 | 1 | 1 | 10 mg/1 mL |
| Clindamycin Phosphate Injection (Cleocin) | Current | 2023-03-21 | 2026-08-18 | 3 | 3 | 150 mg/1 mL |
| Ketorolac Tromethamine Injection | Current | 2018-03-26 | 2026-08-18 | 3 | 3 | 15 mg/1 mL, 30 mg/1 mL |
| Methylprednisolone Acetate Injection (Depo-medrol) | Current | 2021-12-15 | 2026-08-18 | 3 | 3 | 40 mg/1 mL, 80 mg/1 mL |
Package lines filed (12)
The openFDA shortage lines this firm filed, with the agency's own availability text.
| Shortage | Presentation | Strength | Package NDC | Status | Availability (FDA text) | Updated |
|---|---|---|---|---|---|---|
| Bumetanide Injection | Bumetanide, Injection, .25 mg/1 mL (NDC 25021-321-10) | .25 mg/1 mL | 25021-321-10 | Current | Available | 2026-08-18 |
| Bumetanide Injection | Bumetanide, Injection, .25 mg/1 mL (NDC 25021-321-04) | .25 mg/1 mL | 25021-321-04 | Current | Available | 2026-08-18 |
| Rocuronium Bromide Injection | Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 25021-687-05) | 10 mg/1 mL | 25021-687-05 | Current | Available | 2026-08-18 |
| Clindamycin Phosphate Injection | Clindamycin Phosphate, Injection, 150 mg/1 mL (NDC 25021-115-06) | 150 mg/1 mL | 25021-115-06 | Current | Limited Availability | 2026-08-18 |
| Clindamycin Phosphate Injection | Clindamycin Phosphate, Injection, 150 mg/1 mL (NDC 25021-115-04) | 150 mg/1 mL | 25021-115-04 | Current | Unavailable | 2026-08-18 |
| Clindamycin Phosphate Injection | Clindamycin Phosphate, Injection, 150 mg/1 mL (NDC 25021-115-02) | 150 mg/1 mL | 25021-115-02 | Current | Limited Availability | 2026-08-18 |
| Ketorolac Tromethamine Injection | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 25021-701-01) | 30 mg/1 mL | 25021-701-01 | Current | Available | 2026-08-18 |
| Ketorolac Tromethamine Injection | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 25021-701-02) | 30 mg/1 mL | 25021-701-02 | Current | Available | 2026-08-18 |
| Ketorolac Tromethamine Injection | Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 25021-700-01) | 15 mg/1 mL | 25021-700-01 | Current | Limited Availability | 2026-08-18 |
| Methylprednisolone Acetate Injection | Methylprednisolone Acetate, Injection, 80 mg/1 mL (NDC 25021-821-05) | 80 mg/1 mL | 25021-821-05 | Current | Limited Availability | 2026-08-18 |
| Methylprednisolone Acetate Injection | Methylprednisolone Acetate, Injection, 40 mg/1 mL (NDC 25021-820-10) | 40 mg/1 mL | 25021-820-10 | Current | Unavailable | 2026-08-18 |
| Methylprednisolone Acetate Injection | Methylprednisolone Acetate, Injection, 40 mg/1 mL (NDC 25021-820-05) | 40 mg/1 mL | 25021-820-05 | Current | Unavailable | 2026-08-18 |
Recall history (1)
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 |
|---|---|---|---|---|---|
| Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd | D-0539-2026 | Class III | Ongoing | 2026-05-27 | 2026-05-04 |
Browse the wider classification index: Class III recalls.
Products and drugs named (6)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Bumetanide Injection | shortage | 2 | 2026-08-21 |
| Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose | recall | 1 | 2026-05-27 |
| Clindamycin Phosphate Injection | shortage | 3 | 2026-08-18 |
| Ketorolac Tromethamine Injection | shortage | 3 | 2026-08-18 |
| Methylprednisolone Acetate Injection | shortage | 3 | 2026-08-18 |
| Rocuronium Bromide Injection | shortage | 1 | 2026-08-20 |
Indexed activity by year
Counts within the ingested window across 11 dated records — not a trend.
| Year | Recalls | Shortage observations | Approvals | Total |
|---|---|---|---|---|
| 2026 | 1 | 5 | 0 | 6 |
| 2023 | 0 | 2 | 0 | 2 |
| 2021 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 1 | 0 | 1 |
| 2017 | 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 |
|---|---|---|---|---|---|
| Baxter Healthcare | co-reports the same shortage | 14 | 0 | 14 | 2026-08-20 |
| Msn Laboratories Private Ltd | co-reports the same shortage | 1 | 0 | 1 | 2026-08-21 |
| Mylan Institutional, A Viatris Company | co-reports the same shortage | 6 | 0 | 6 | 2026-08-20 |
| Par Health Usa, LLC | co-reports the same shortage | 3 | 1 | 2 | 2026-08-20 |
| Sandoz Inc | co-reports the same shortage | 4 | 1 | 3 | 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 |
| 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 |
| Atropine Sulfate Injection | Current | same therapeutic category | 2012-01-01 | 2026-08-18 | 6 | 3 |
| Bupivacaine Hydrochloride Injection | Current | same therapeutic category | 2018-02-20 | 2026-08-18 | 1 | 1 |
| Conivaptan Hydrochloride Injection | Current | same therapeutic category | 2022-03-14 | 2026-08-18 | 1 | 1 |
| Furosemide Injection | Current | same therapeutic category | 2020-04-07 | 2026-08-18 | 6 | 3 |
| Lidocaine Hydrochloride Injection | Current | same therapeutic category | 2012-02-22 | 2026-08-18 | 2 | 2 |
Source limitations
Built from the 6 ingested FDA records for this firm (1 recall, 5 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.