Teva Pharmaceuticals Usa, Inc: FDA regulatory profile
Teva Pharmaceuticals Usa, Inc appears in 8 indexed U.S. FDA records: 1 recall record and 7 drug-shortage entries (from 15 openFDA source rows), naming 8 distinct products. Latest dated event: a shortage record dated 2026-08-20. Observations run 2017-11-01 to 2026-08-20 — 3214 days, 15 dated records across 4 calendar years, busiest 2026 with 8. Recalls: 1 Class II (100%); 1 ongoing by lifecycle status, reported 2026-05-13; 1 with an FDA recall number, 1 with an initiation date, across 1 state, grouped into 1 FDA recall event. Shortages: 7 current, averaging 2.1 package lines each across 6 FDA therapeutic categories, 13 strengths, 208 package NDCs and 8 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 | 8 |
|---|---|
| Recall records | 1 |
| Shortage entries | 7 |
| Source rows filed | 15 |
| Approval records | 0 |
| Current shortages | 7 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 8 |
| Recall classifications | Class II: 1 |
| Recall statuses | Ongoing: 1 |
| First observed | 2017-11-01 |
| Latest observed | 2026-08-20 |
| Latest event type | shortage |
| Dated observations | 15 |
| Years covered | 4 |
| Span (days) | 3214 |
| Busiest year | 2026 (8 records) |
| Lines per entry (mean) | 2.1 |
| Therapeutic categories | 6 |
| Distinct strengths | 13 |
| Package NDCs | 208 |
| Brand names | 8 |
| 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 II | 1 | 100% |
| Recall status | Ongoing | 1 | 100% |
| Shortage status | Current | 7 | 100% |
| Therapeutic category | Psychiatry | 4 | 57% |
| Therapeutic category | Oncology | 2 | 29% |
| Therapeutic category | Analgesia/Addiction | 1 | 14% |
| Therapeutic category | Neurology | 1 | 14% |
| Therapeutic category | Pediatric | 1 | 14% |
| Therapeutic category | Rheumatology | 1 | 14% |
Current shortages (7)
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 | 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg, 5 mg; 5 mg; 5 mg; 5 mg, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg |
| Lisdexamfetamine Dimesylate Capsule (Vyvanse) | Current | 2023-07-14 | 2026-08-20 | 3 | 3 | 10 mg, 60 mg, 70 mg |
| Methylphenidate Hydrochloride Tablet, Extended Release (Concerta, Relexxii) | Current | 2023-07-26 | 2026-08-19 | 3 | 3 | 27 mg, 36 mg, 54 mg |
| Carboplatin Injection (Kyxata, Paraplatin) | Current | 2023-04-28 | 2026-08-18 | 1 | 1 | 10 mg/1 mL |
| Clonazepam Tablet (Klonopin) | Current | 2023-03-10 | 2026-08-17 | 2 | 2 | .5 mg, 2 mg |
| Hydromorphone Hydrochloride Injection | Current | 2017-11-01 | 2026-08-17 | 1 | 1 | 10 mg/1 mL |
| Methotrexate Sodium Injection | Current | 2023-03-13 | 2026-08-17 | 1 | 1 | 25 mg/1 mL |
Package lines filed (15)
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 0555-0974-02) | 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg | 0555-0974-02 | Current | Available | 2026-08-17 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 0555-0777-02) | 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg | 0555-0777-02 | Current | Available | 2026-08-17 |
| 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 0555-0973-02) | 5 mg; 5 mg; 5 mg; 5 mg | 0555-0973-02 | Current | Available | 2026-08-17 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | Adderall, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 57844-115-01) | 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg | 57844-115-01 | Current | Available | 2026-08-17 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 0480-3564-01) | 70 mg | 0480-3564-01 | Current | Available | 2026-08-17 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 0480-3570-01) | 60 mg | 0480-3570-01 | Current | Available | 2026-08-17 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0480-3565-01) | 10 mg | 0480-3565-01 | Current | Available | 2026-08-17 |
| Methylphenidate Hydrochloride Tablet, Extended Release | Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 62037-727-01) | 54 mg | 62037-727-01 | Current | Limited Availability | 2026-08-17 |
| Methylphenidate Hydrochloride Tablet, Extended Release | Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 62037-734-01) | 27 mg | 62037-734-01 | Current | Available | 2026-08-17 |
| Methylphenidate Hydrochloride Tablet, Extended Release | Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 62037-726-01) | 36 mg | 62037-726-01 | Current | Limited Availability | 2026-08-17 |
| Carboplatin Injection | Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4239-01) | 10 mg/1 mL | 0703-4239-01 | Current | Limited Availability | 2026-08-17 |
| Clonazepam Tablet | Clonazepam, Tablet, .5 mg (NDC 0093-0832-01) | .5 mg | 0093-0832-01 | Current | Available | 2026-08-17 |
| Clonazepam Tablet | Clonazepam, Tablet, 2 mg (NDC 0093-3213-01) | 2 mg | 0093-3213-01 | Current | Available | 2026-08-17 |
| Hydromorphone Hydrochloride Injection | Hydromorphone Hydrochloride, Injection, 10 mg/1 mL (NDC 0703-0113-03) | 10 mg/1 mL | 0703-0113-03 | Current | Available | 2026-08-17 |
| Methotrexate Sodium Injection | Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3675-01) | 25 mg/1 mL | 0703-3675-01 | Current | Unavailable | 2026-08-17 |
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 |
|---|---|---|---|---|---|
| Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Sin | D-0519-2026 | Class II | Ongoing | 2026-05-13 | 2026-04-24 |
Browse the wider classification index: Class II recalls.
Products and drugs named (8)
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 |
| Carboplatin Injection | shortage | 1 | 2026-08-18 |
| Clonazepam Tablet | shortage | 2 | 2026-08-17 |
| Hydromorphone Hydrochloride Injection | shortage | 1 | 2026-08-17 |
| Lisdexamfetamine Dimesylate Capsule | shortage | 3 | 2026-08-20 |
| Methotrexate Sodium Injection | shortage | 1 | 2026-08-17 |
| Methylphenidate Hydrochloride Tablet, Extended Release | shortage | 3 | 2026-08-19 |
| Octreotide Acetate for Injectable Suspension, for gluteal intramuscula | recall | 1 | 2026-05-13 |
Indexed activity by year
Counts within the ingested window across 15 dated records — not a trend.
| Year | Recalls | Shortage observations | Approvals | Total |
|---|---|---|---|---|
| 2026 | 1 | 7 | 0 | 8 |
| 2023 | 0 | 5 | 0 | 5 |
| 2022 | 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 |
|---|---|---|---|---|---|
| Accord Healthcare, Inc. | co-reports the same shortage | 7 | 1 | 6 | 2026-08-20 |
| Alvogen | co-reports the same shortage | 3 | 0 | 2 | 2026-08-20 |
| Cheplapharm Arzneimittel Gmbh | co-reports the same shortage | 1 | 0 | 1 | 2026-08-17 |
| 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 |
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 |
| Dextrose Monohydrate 50% Injection | Current | same therapeutic category | 2022-01-13 | 2026-08-18 | 1 | 1 |
| Ketorolac Tromethamine Injection | Current | same therapeutic category | 2018-03-26 | 2026-08-18 | 5 | 2 |
| Lidocaine Hydrochloride Injection | Current | same therapeutic category | 2012-02-22 | 2026-08-18 | 2 | 2 |
| Lorazepam Injection | Current | same therapeutic category | 2018-05-03 | 2026-08-18 | 1 | 1 |
| Methylprednisolone Acetate Injection | Current | same therapeutic category | 2021-12-15 | 2026-08-18 | 4 | 2 |
| Midazolam Hydrochloride Injection | Current | same therapeutic category | 2020-04-02 | 2026-08-18 | 4 | 2 |
Source limitations
Built from the 8 ingested FDA records for this firm (1 recall, 7 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.