Sun Pharmaceutical Industries Inc: FDA regulatory profile
Sun Pharmaceutical Industries Inc appears in 6 indexed U.S. FDA records: 6 recall records, naming 6 distinct products. Latest dated event: a recall record dated 2026-07-08. Observations run 2026-06-10 to 2026-07-08 — 28 days, 6 dated records across 1 calendar year, busiest 2026 with 6. Recalls: 1 Class I (17%), 4 Class II (67%) and 1 Class III (17%); 6 ongoing by lifecycle status, reported 2026-06-10 to 2026-07-08; 6 with an FDA recall number, 6 with an initiation date, across 1 state, grouped into 5 FDA recall events. 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. Recall records: Fexofenadine Hydrochloride Tablets (D-0654-2026, Class III, 2026-07-08), Perampanel CIII Tablets (D-0628-2026, Class II, 2026-07-01), DOXOrubin Hydrochloride Liposome injection (D-0580-2026, Class I, 2026-06-17) and Budesonide Inhalation Suspension (D-0607-2026, Class II, 2026-06-17). Recalling-firm addresses are recorded in NJ.
Regulatory snapshot
| Indexed records | 6 |
|---|---|
| Recall records | 6 |
| Shortage entries | 0 |
| Source rows filed | 0 |
| Approval records | 0 |
| Current shortages | 0 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 6 |
| Recall classifications | Class I: 1 · Class II: 4 · Class III: 1 |
| Recall statuses | Ongoing: 6 |
| First observed | 2026-06-10 |
| Latest observed | 2026-07-08 |
| Latest event type | recall |
| Dated observations | 6 |
| Years covered | 1 |
| Span (days) | 28 |
| Busiest year | 2026 (6 records) |
| Recall states | 1 |
| With recall number | 6 of 6 |
| FDA recall events | 5 |
| Related firms / shortages | 0 / 0 |
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 I | 1 | 17% |
| Recall classification | Class II | 4 | 67% |
| Recall classification | Class III | 1 | 17% |
| Recall status | Ongoing | 6 | 100% |
Recall history (6)
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 |
|---|---|---|---|---|---|
| Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Dis | D-0654-2026 | Class III | Ongoing | 2026-07-08 | 2026-06-01 |
| Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries | D-0628-2026 | Class II | Ongoing | 2026-07-01 | 2026-06-17 |
| DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, | D-0580-2026 | Class I | Ongoing | 2026-06-17 | 2026-05-12 |
| Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single | D-0607-2026 | Class II | Ongoing | 2026-06-17 | 2026-05-29 |
| Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufac | D-0598-2026 | Class II | Ongoing | 2026-06-10 | 2026-05-22 |
| Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufac | D-0599-2026 | Class II | Ongoing | 2026-06-10 | 2026-05-22 |
| FDA recall event | Records | Classification(s) | First reported | Last reported |
|---|---|---|---|---|
| 99066 | 2 | Class II | 2026-06-10 | 2026-06-10 |
| 98921 | 1 | Class I | 2026-06-17 | 2026-06-17 |
| 99110 | 1 | Class III | 2026-07-08 | 2026-07-08 |
| 99113 | 1 | Class II | 2026-06-17 | 2026-06-17 |
| 99256 | 1 | Class II | 2026-07-01 | 2026-07-01 |
Browse the wider classification index: Class I recalls · 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 |
|---|---|---|---|
| Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Do | recall | 1 | 2026-06-17 |
| DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 m | recall | 1 | 2026-06-17 |
| Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tab | recall | 1 | 2026-07-08 |
| Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharma | recall | 1 | 2026-07-01 |
| Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Fort | recall | 1 | 2026-06-10 |
| Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Fort | recall | 1 | 2026-06-10 |
Source limitations
Built from the 6 ingested FDA records for this firm (6 recall, 0 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.