Lupin Pharmaceuticals Inc.
Lupin Pharmaceuticals Inc. appears in FDA public data with 122 recalls — including 5 Class I (most serious) —, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0723-2026, Class II) was initiated on June 23, 2026.
Summary
- Total Recalls
- 122 (5 Class I)
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0723-2026 | Class II | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Gl | June 23, 2026 |
| D-0655-2026 | Class II | prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b | June 4, 2026 |
| D-0541-2026 | Class II | Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., | April 24, 2026 |
| D-0220-2026 | Class II | Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' | November 13, 2025 |
| D-0227-2026 | Class II | Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Ph | November 5, 2025 |
| D-0542-2025 | Class II | Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured | July 2, 2025 |
| D-0537-2025 | Class II | clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite | June 27, 2025 |
| D-0532-2025 | Class II | Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lu | June 20, 2025 |
| D-0377-2025 | Class II | clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin P | April 10, 2025 |
| D-0167-2025 | Class II | Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupi | December 20, 2024 |
| D-0054-2025 | Class II | Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) | October 23, 2024 |
| D-0053-2025 | Class II | Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 5 | October 23, 2024 |
| D-0052-2025 | Class II | Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) | October 23, 2024 |
| D-0648-2024 | Class II | Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharma | August 21, 2024 |
| D-0559-2024 | Class II | Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, | May 30, 2024 |
| D-0518-2024 | Class II | Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for | May 8, 2024 |
| D-0497-2024 | Class II | Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manu | April 24, 2024 |
| D-0496-2024 | Class II | Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manu | April 24, 2024 |
| D-0437-2024 | Class II | Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, In | March 21, 2024 |
| D-0337-2024 | Class II | Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Dire | February 5, 2024 |