Lupin Pharmaceuticals Inc.: FDA regulatory profile
Lupin Pharmaceuticals Inc. appears in 5 indexed U.S. FDA records: 3 recall records and 2 drug-shortage entries (from 7 openFDA source rows), naming 5 distinct products. Latest dated event: a shortage record dated 2026-08-18. Observations run 2021-12-22 to 2026-08-18 — 1700 days, 7 dated records across 3 calendar years, busiest 2026 with 5. Recalls: 3 Class II (100%); 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: 2 current, averaging 3.5 package lines each across 2 FDA therapeutic categories, 6 strengths, 20 package NDCs and 2 brand names. 2 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 | 5 |
|---|---|
| Recall records | 3 |
| Shortage entries | 2 |
| Source rows filed | 7 |
| Approval records | 0 |
| Current shortages | 2 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 5 |
| Recall classifications | Class II: 3 |
| Recall statuses | Ongoing: 3 |
| First observed | 2021-12-22 |
| Latest observed | 2026-08-18 |
| Latest event type | shortage |
| Dated observations | 7 |
| Years covered | 3 |
| Span (days) | 1700 |
| Busiest year | 2026 (5 records) |
| Lines per entry (mean) | 3.5 |
| Therapeutic categories | 2 |
| Distinct strengths | 6 |
| Package NDCs | 20 |
| Brand names | 2 |
| Recall states | 1 |
| With recall number | 3 of 3 |
| FDA recall events | 3 |
| Related firms / shortages | 2 / 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 | 3 | 100% |
| Recall status | Ongoing | 3 | 100% |
| Shortage status | Current | 2 | 100% |
| Therapeutic category | Anti-Infective | 1 | 50% |
| Therapeutic category | Cardiovascular | 1 | 50% |
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 |
|---|---|---|---|---|---|---|
| Quinapril Hydrochloride Tablet (Accupril) | Current | 2023-01-19 | 2026-08-18 | 4 | 4 | 10 mg, 20 mg, 40 mg, 5 mg |
| Rifampin Capsule (Rifadin) | Current | 2021-12-22 | 2026-08-18 | 3 | 3 | 150 mg, 300 mg |
Package lines filed (7)
The openFDA shortage lines this firm filed, with the agency's own availability text.
| Shortage | Presentation | Strength | Package NDC | Status | Availability (FDA text) | Updated |
|---|---|---|---|---|---|---|
| Quinapril Hydrochloride Tablet | Quinapril Hydrochloride, Tablet, 5 mg (NDC 68180-556-09) | 5 mg | 68180-556-09 | Current | Unavailable | 2026-08-18 |
| Quinapril Hydrochloride Tablet | Quinapril Hydrochloride, Tablet, 20 mg (NDC 68180-558-09) | 20 mg | 68180-558-09 | Current | Unavailable | 2026-08-18 |
| Quinapril Hydrochloride Tablet | Quinapril Hydrochloride, Tablet, 40 mg (NDC 68180-554-09) | 40 mg | 68180-554-09 | Current | Unavailable | 2026-08-18 |
| Quinapril Hydrochloride Tablet | Quinapril Hydrochloride, Tablet, 10 mg (NDC 68180-557-09) | 10 mg | 68180-557-09 | Current | Unavailable | 2026-08-18 |
| Rifampin Capsule | Rifampin, Capsule, 150 mg (NDC 68180-658-06) | 150 mg | 68180-658-06 | Current | Available | 2026-08-18 |
| Rifampin Capsule | Rifampin, Capsule, 300 mg (NDC 68180-659-06) | 300 mg | 68180-659-06 | Current | Available | 2026-08-18 |
| Rifampin Capsule | Rifampin, Capsule, 300 mg (NDC 68180-659-07) | 300 mg | 68180-659-07 | 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 |
|---|---|---|---|---|---|
| prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748- | D-0655-2026 | Class II | Ongoing | 2026-07-08 | 2026-06-04 |
| Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Dilu | D-0723-2026 | Class II | Ongoing | 2026-07-08 | 2026-06-23 |
| Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceutic | D-0541-2026 | Class II | Ongoing | 2026-05-27 | 2026-04-24 |
| FDA recall event | Records | Classification(s) | First reported | Last reported |
|---|---|---|---|---|
| 98809 | 1 | Class II | 2026-05-27 | 2026-05-27 |
| 99144 | 1 | Class II | 2026-07-08 | 2026-07-08 |
| 99296 | 1 | Class II | 2026-07-08 | 2026-07-08 |
Browse the wider classification index: Class II recalls.
Products and drugs named (5)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP | recall | 1 | 2026-07-08 |
| Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for | recall | 1 | 2026-05-27 |
| prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, | recall | 1 | 2026-07-08 |
| Quinapril Hydrochloride Tablet | shortage | 4 | 2026-08-18 |
| Rifampin Capsule | shortage | 3 | 2026-08-18 |
Indexed activity by year
Counts within the ingested window across 7 dated records — not a trend.
| Year | Recalls | Shortage observations | Approvals | Total |
|---|---|---|---|---|
| 2026 | 3 | 2 | 0 | 5 |
| 2023 | 0 | 1 | 0 | 1 |
| 2021 | 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 |
|---|---|---|---|---|---|
| Epic Pharma, LLC | co-reports the same shortage | 2 | 0 | 2 | 2026-08-20 |
| Mylan Institutional, A Viatris Company | reports a shortage of the same substance | 6 | 0 | 6 | 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 |
|---|---|---|---|---|---|---|
| Bumetanide Injection | Current | same therapeutic category | 2017-12-13 | 2026-08-21 | 6 | 2 |
| Rifampin Injection | Current | same substance | 2021-02-17 | 2026-08-20 | 1 | 1 |
| Clindamycin Phosphate Injection | Current | same therapeutic category | 2023-03-21 | 2026-08-18 | 10 | 3 |
| 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 |
| Metronidazole Injection | Current | same therapeutic category | 2022-01-13 | 2026-08-18 | 2 | 1 |
| Dobutamine Hydrochloride Injection | Current | same therapeutic category | 2017-11-06 | 2026-08-17 | 1 | 1 |
Source limitations
Built from the 5 ingested FDA records for this firm (3 recall, 2 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.