Sandoz Inc: FDA regulatory profile
Sandoz Inc appears in 4 indexed U.S. FDA records: 1 recall record and 3 drug-shortage entries (from 11 openFDA source rows), naming 4 distinct products. Latest dated event: a shortage record dated 2026-08-20. Observations run 2022-10-12 to 2026-08-20 — 1408 days, 7 dated records across 3 calendar years, busiest 2026 with 4. Recalls: 1 Class III (100%); 1 ongoing by lifecycle status, reported 2026-06-24; 1 with an FDA recall number, 1 with an initiation date, across 1 state, grouped into 1 FDA recall event. Shortages: 3 current, averaging 3.7 package lines each across 3 FDA therapeutic categories, 8 strengths, 133 package NDCs and 3 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.
Regulatory snapshot
| Indexed records | 4 |
|---|---|
| Recall records | 1 |
| Shortage entries | 3 |
| Source rows filed | 11 |
| Approval records | 0 |
| Current shortages | 3 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 4 |
| Recall classifications | Class III: 1 |
| Recall statuses | Ongoing: 1 |
| First observed | 2022-10-12 |
| Latest observed | 2026-08-20 |
| Latest event type | shortage |
| Dated observations | 7 |
| Years covered | 3 |
| Span (days) | 1408 |
| Busiest year | 2026 (4 records) |
| Lines per entry (mean) | 3.7 |
| Therapeutic categories | 3 |
| Distinct strengths | 8 |
| Package NDCs | 133 |
| Brand names | 3 |
| Recall states | 1 |
| With recall number | 1 of 1 |
| FDA recall events | 1 |
| 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 |
|---|---|---|---|
| Recall classification | Class III | 1 | 100% |
| Recall status | Ongoing | 1 | 100% |
| Shortage status | Current | 3 | 100% |
| Therapeutic category | Anesthesia | 1 | 33% |
| Therapeutic category | Anti-Infective | 1 | 33% |
| Therapeutic category | Psychiatry | 1 | 33% |
Current shortages (3)
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 |
|---|---|---|---|---|---|---|
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Adderall, Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,cii) | Current | 2022-10-12 | 2026-08-20 | 4 | 4 | 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg, 5 mg; 5 mg; 5 mg; 5 mg, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg |
| Rocuronium Bromide Injection | Current | 2023-02-15 | 2026-08-20 | 2 | 2 | 10 mg/1 mL |
| Clindamycin Phosphate Injection (Cleocin) | Current | 2023-03-21 | 2026-08-18 | 5 | 5 | 12 mg/1 mL, 18 mg/1 mL, 6 mg/1 mL |
Package lines filed (11)
The openFDA shortage lines this firm filed, with the agency's own availability text.
| Shortage | Presentation | Strength | Package NDC | Status | Availability (FDA text) | Updated |
|---|---|---|---|---|---|---|
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 0185-2099-01) | 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg | 0185-2099-01 | Current | Available | 2026-08-18 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 0185-0842-01) | 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg | 0185-0842-01 | Current | Available | 2026-08-18 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 0185-0853-01) | 5 mg; 5 mg; 5 mg; 5 mg | 0185-0853-01 | Current | Available | 2026-08-18 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 0185-2098-01) | 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg | 0185-2098-01 | Current | Available | 2026-08-18 |
| Rocuronium Bromide Injection | Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 0781-3220-95) | 10 mg/1 mL | 0781-3220-95 | Current | Available | 2026-08-18 |
| Rocuronium Bromide Injection | Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 0781-3220-92) | 10 mg/1 mL | 0781-3220-92 | Current | Available | 2026-08-18 |
| Clindamycin Phosphate Injection | Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 12 mg/1 mL (NDC 72572-074-24) | 12 mg/1 mL | 72572-074-24 | Current | Available | 2026-08-18 |
| Clindamycin Phosphate Injection | Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 18 mg/1 mL (NDC 0781-3290-09) | 18 mg/1 mL | 0781-3290-09 | Current | Available | 2026-08-18 |
| Clindamycin Phosphate Injection | Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 6 mg/1 mL (NDC 0781-3288-09) | 6 mg/1 mL | 0781-3288-09 | Current | Available | 2026-08-18 |
| Clindamycin Phosphate Injection | Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 18 mg/1 mL (NDC 72572-076-24) | 18 mg/1 mL | 72572-076-24 | Current | Available | 2026-08-18 |
| Clindamycin Phosphate Injection | Clindamycin Phosphate In 5% Dextrose In Plastic Container, Injection, 12 mg/1 mL (NDC 0781-3289-09) | 12 mg/1 mL | 0781-3289-09 | Current | Available | 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 |
|---|---|---|---|---|---|
| Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only | D-0608-2026 | Class III | Ongoing | 2026-06-24 | 2026-06-01 |
Browse the wider classification index: Class III recalls.
Products and drugs named (4)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetam | shortage | 4 | 2026-08-20 |
| Clindamycin Phosphate Injection | shortage | 5 | 2026-08-18 |
| Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules | recall | 1 | 2026-06-24 |
| Rocuronium Bromide Injection | shortage | 2 | 2026-08-20 |
Indexed activity by year
Counts within the ingested window across 7 dated records — not a trend.
| Year | Recalls | Shortage observations | Approvals | Total |
|---|---|---|---|---|
| 2026 | 1 | 3 | 0 | 4 |
| 2023 | 0 | 2 | 0 | 2 |
| 2022 | 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 |
|---|---|---|---|---|---|
| Alvogen | co-reports the same shortage | 3 | 0 | 2 | 2026-08-20 |
| Baxter Healthcare | co-reports the same shortage | 14 | 0 | 14 | 2026-08-20 |
| Elite Laboratories, Inc. | co-reports the same shortage | 2 | 0 | 2 | 2026-08-20 |
| Epic Pharma, LLC | co-reports the same shortage | 2 | 0 | 2 | 2026-08-20 |
| Granules Pharmaceuticals Inc. | co-reports the same shortage | 1 | 0 | 1 | 2026-08-20 |
| Lannett Company Inc. | co-reports the same shortage | 6 | 3 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| Lidocaine Hydrochloride Injection | Current | same therapeutic category | 2012-02-22 | 2026-08-18 | 2 | 2 |
| Metronidazole Injection | Current | same therapeutic category | 2022-01-13 | 2026-08-18 | 2 | 1 |
| Midazolam Hydrochloride Injection | Current | same therapeutic category | 2020-04-02 | 2026-08-18 | 4 | 2 |
| Rifampin Capsule | Current | same therapeutic category | 2021-12-22 | 2026-08-18 | 8 | 2 |
| Ropivacaine Hydrochloride Injection | Current | same therapeutic category | 2018-03-27 | 2026-08-18 | 6 | 1 |
Source limitations
Built from the 4 ingested FDA records for this firm (1 recall, 3 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.