Specgx LLC: FDA regulatory profile
Specgx LLC appears in 5 indexed U.S. FDA records: 2 drug-shortage entries (from 10 openFDA source rows) and 3 approval records, naming 5 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 5. Shortages: 2 current, averaging 5 package lines each across 1 FDA therapeutic category, 10 strengths, 134 package NDCs and 3 brand names. Approvals: 3 records, 3 carrying an approval date. 6 related firms and 1 adjacent shortage entry 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 (5), 2023 (1), 2022 (1). Shortage entries include Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (Current, since 2022-10-12, 3 lines) and Lisdexamfetamine Dimesylate Capsule (Current, since 2023-07-14, 7 lines).
Regulatory snapshot
| Indexed records | 5 |
|---|---|
| Recall records | 0 |
| Shortage entries | 2 |
| Source rows filed | 10 |
| Approval records | 3 |
| Current shortages | 2 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 5 |
| Recall classifications | 0 |
| Recall statuses | 0 |
| 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 (5 records) |
| Lines per entry (mean) | 5 |
| Therapeutic categories | 1 |
| Distinct strengths | 10 |
| Package NDCs | 134 |
| Brand names | 3 |
| Related firms / shortages | 6 / 1 |
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 | 2 | 100% |
| Therapeutic category | Psychiatry | 2 | 100% |
Current shortages (2)
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 | 3 | 3 | 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg, 5 mg; 5 mg; 5 mg; 5 mg |
| Lisdexamfetamine Dimesylate Capsule (Vyvanse) | Current | 2023-07-14 | 2026-08-20 | 7 | 7 | 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg |
Package lines filed (10)
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, 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg (NDC 0406-8884-01) | 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg | 0406-8884-01 | Current | Available | 2026-08-20 |
| 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 0406-8885-01) | 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg | 0406-8885-01 | Current | Available | 2026-08-20 |
| 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 0406-8893-01) | 5 mg; 5 mg; 5 mg; 5 mg | 0406-8893-01 | Current | Available | 2026-08-20 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 0406-5113-01) | 30 mg | 0406-5113-01 | Current | Available | 2026-08-20 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 0406-5115-01) | 50 mg | 0406-5115-01 | Current | Available | 2026-08-20 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 0406-5114-01) | 40 mg | 0406-5114-01 | Current | Available | 2026-08-20 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 0406-5116-01) | 60 mg | 0406-5116-01 | Current | Available | 2026-08-20 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 0406-5117-01) | 70 mg | 0406-5117-01 | Current | Available | 2026-08-20 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0406-5111-01) | 10 mg | 0406-5111-01 | Current | Available | 2026-08-20 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 0406-5112-01) | 20 mg | 0406-5112-01 | Current | Available | 2026-08-20 |
Approval records (3)
| Product | Generic | Application | Marketing status | Approved |
|---|---|---|---|---|
| Buprenorphine Hydrochloride | Buprenorphine Hydrochloride | ANDA218473 | Prescription | 2026-08-14 |
| Buprenorphine Hydrochloride And Naloxone Hydrochloride | Buprenorphine Hydrochloride | ANDA207000 | Prescription | 2026-08-14 |
| Dextroamphetamine Sulfate | Dextroamphetamine Sulfate | ANDA076353 | Prescription | 2026-08-14 |
Approval records are indexed on the drug approvals hub; they do not have individual record pages on this site.
Products and drugs named (5)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetam | shortage | 3 | 2026-08-20 |
| Buprenorphine Hydrochloride | approval | — | — |
| Buprenorphine Hydrochloride And Naloxone Hydrochloride | approval | — | — |
| Dextroamphetamine Sulfate | approval | — | — |
| Lisdexamfetamine Dimesylate Capsule | shortage | 7 | 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 | 0 | 2 | 3 | 5 |
| 2023 | 0 | 1 | 0 | 1 |
| 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 |
| 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 |
| Mylan Pharmaceuticals Inc., A Viatris Company | 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 |
|---|---|---|---|---|---|---|
| Lisdexamfetamine Dimesylate Tablet, Chewable | Current | same therapeutic category | 2023-07-14 | 2026-08-17 | 2 | 1 |
Source limitations
Built from the 5 ingested FDA records for this firm (0 recall, 2 shortage, 3 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.