Lannett Company Inc.: FDA regulatory profile
Lannett Company Inc. appears in 6 indexed U.S. FDA records: 3 recall records and 3 drug-shortage entries (from 18 openFDA source rows), naming 6 distinct products. Latest dated event: a shortage record dated 2026-08-20. Observations run 2022-10-12 to 2026-08-20 — 1408 days, 9 dated records across 3 calendar years, busiest 2026 with 6. Recalls: 2 Class II (67%) and 1 Class III (33%); 3 ongoing by lifecycle status, reported 2026-05-27 to 2026-07-08; 3 with an FDA recall number, 3 with an initiation date, across 1 state, grouped into 3 FDA recall events. Shortages: 3 current, averaging 6 package lines each across 1 FDA therapeutic category, 18 strengths, 165 package NDCs and 5 brand names. 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.
Regulatory snapshot
| Indexed records | 6 |
|---|---|
| Recall records | 3 |
| Shortage entries | 3 |
| Source rows filed | 18 |
| Approval records | 0 |
| Current shortages | 3 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 6 |
| Recall classifications | Class II: 2 · Class III: 1 |
| Recall statuses | Ongoing: 3 |
| First observed | 2022-10-12 |
| Latest observed | 2026-08-20 |
| Latest event type | shortage |
| Dated observations | 9 |
| Years covered | 3 |
| Span (days) | 1408 |
| Busiest year | 2026 (6 records) |
| Lines per entry (mean) | 6 |
| Therapeutic categories | 1 |
| Distinct strengths | 18 |
| Package NDCs | 165 |
| Brand names | 5 |
| Recall states | 1 |
| With recall number | 3 of 3 |
| FDA recall events | 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 |
|---|---|---|---|
| Recall classification | Class II | 2 | 67% |
| Recall classification | Class III | 1 | 33% |
| Recall status | Ongoing | 3 | 100% |
| Shortage status | Current | 3 | 100% |
| Therapeutic category | Psychiatry | 3 | 100% |
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 | 7 | 7 | 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg, 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg, 3.125 mg; 3.125 mg; 3.125 mg; 3.125 mg, 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 | 7 | 7 | 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg |
| Methylphenidate Hydrochloride Tablet, Extended Release (Concerta, Relexxii) | Current | 2023-07-26 | 2026-08-19 | 4 | 4 | 18 mg, 27 mg, 36 mg, 54 mg |
Package lines filed (18)
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, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 0527-0764-37) | 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg | 0527-0764-37 | 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 0527-1502-37) | 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg | 0527-1502-37 | 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, 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg (NDC 0527-0761-37) | 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg | 0527-0761-37 | 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 0527-0760-37) | 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg | 0527-0760-37 | 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, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 0527-0766-37) | 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg | 0527-0766-37 | 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, 3.125 mg; 3.125 mg; 3.125 mg; 3.125 mg (NDC 0527-0763-37) | 3.125 mg; 3.125 mg; 3.125 mg; 3.125 mg | 0527-0763-37 | 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 0527-1505-37) | 5 mg; 5 mg; 5 mg; 5 mg | 0527-1505-37 | Current | Available | 2026-08-18 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 0527-4663-37) | 30 mg | 0527-4663-37 | Current | Available | 2026-08-18 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0527-4661-37) | 10 mg | 0527-4661-37 | Current | Available | 2026-08-18 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 0527-4664-37) | 40 mg | 0527-4664-37 | Current | Available | 2026-08-18 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 0527-4666-37) | 60 mg | 0527-4666-37 | Current | Available | 2026-08-18 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 0527-4665-37) | 50 mg | 0527-4665-37 | Current | Available | 2026-08-18 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 0527-4662-37) | 20 mg | 0527-4662-37 | Current | Available | 2026-08-18 |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 0527-4667-37) | 70 mg | 0527-4667-37 | Current | Available | 2026-08-18 |
| Methylphenidate Hydrochloride Tablet, Extended Release | Methylphenidate Hydrochloride, Tablet, Extended Release, 18 mg (NDC 62175-310-37) | 18 mg | 62175-310-37 | Current | Available | 2026-08-18 |
| Methylphenidate Hydrochloride Tablet, Extended Release | Methylphenidate Hydrochloride, Tablet, Extended Release, 54 mg (NDC 62175-313-37) | 54 mg | 62175-313-37 | Current | Available | 2026-08-18 |
| Methylphenidate Hydrochloride Tablet, Extended Release | Methylphenidate Hydrochloride, Tablet, Extended Release, 36 mg (NDC 62175-312-37) | 36 mg | 62175-312-37 | Current | Available | 2026-08-18 |
| Methylphenidate Hydrochloride Tablet, Extended Release | Methylphenidate Hydrochloride, Tablet, Extended Release, 27 mg (NDC 62175-311-37) | 27 mg | 62175-311-37 | Current | Available | 2026-08-18 |
Recall history (3)
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 |
|---|---|---|---|---|---|
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate | D-0660-2026 | Class II | Ongoing | 2026-07-08 | 2026-06-26 |
| Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: | D-0584-2026 | Class II | Ongoing | 2026-06-10 | 2026-05-27 |
| Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, | D-0533-2026 | Class III | Ongoing | 2026-05-27 | 2026-04-24 |
| FDA recall event | Records | Classification(s) | First reported | Last reported |
|---|---|---|---|---|
| 98791 | 1 | Class III | 2026-05-27 | 2026-05-27 |
| 99107 | 1 | Class II | 2026-06-10 | 2026-06-10 |
| 99319 | 1 | Class II | 2026-07-08 | 2026-07-08 |
Browse the wider classification index: Class II recalls · Class III recalls.
Products and drugs named (6)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetam | shortage | 7 | 2026-08-20 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextr | recall | 1 | 2026-07-08 |
| Lisdexamfetamine Dimesylate Capsule | shortage | 7 | 2026-08-20 |
| Methylphenidate Hydrochloride Tablet, Extended Release | shortage | 4 | 2026-08-19 |
| Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx O | recall | 1 | 2026-06-10 |
| Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed b | recall | 1 | 2026-05-27 |
Indexed activity by year
Counts within the ingested window across 9 dated records — not a trend.
| Year | Recalls | Shortage observations | Approvals | Total |
|---|---|---|---|---|
| 2026 | 3 | 3 | 0 | 6 |
| 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 |
| 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 |
| Janssen Pharmaceuticals | co-reports the same shortage | 1 | 0 | 1 | 2026-08-19 |
| 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 6 ingested FDA records for this firm (3 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.