Lupin Pharmaceuticals Inc. Provisional
FDA Flags (51)
Class II RecallJul 2026
Lupin Pharmaceuticals Inc.
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-3
Classification: Class II
Class II RecallJul 2026
Lupin Pharmaceuticals Inc.
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe
Classification: Class II
Class II RecallMay 2026
Lupin Pharmaceuticals Inc.
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, M
Classification: Class II
Class II RecallDec 2025
Lupin Pharmaceuticals Inc.
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Man
Classification: Class II
Class II RecallDec 2025
Lupin Pharmaceuticals Inc.
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc.,
Classification: Class II
Class II RecallAug 2025
Lupin Pharmaceuticals Inc.
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceu
Classification: Class II
Class II RecallJul 2025
Lupin Pharmaceuticals Inc.
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida
Classification: Class II
Class II RecallJul 2025
Lupin Pharmaceuticals Inc.
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals,
Classification: Class II
Class II RecallApr 2025
Lupin Pharmaceuticals Inc.
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc.
Classification: Class II
Class II RecallJan 2025
Lupin Pharmaceuticals Inc.
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, I
Classification: Class II
Class II RecallNov 2024
Lupin Pharmaceuticals Inc.
Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180
Classification: Class II
Class II RecallNov 2024
Lupin Pharmaceuticals Inc.
Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 6818
Classification: Class II
Class II RecallNov 2024
Lupin Pharmaceuticals Inc.
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-
Classification: Class II
Class II RecallSep 2024
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Bal
Classification: Class II
Class II RecallJun 2024
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: L
Classification: Class II
Class II RecallJun 2024
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceutic
Classification: Class II
Class II RecallMay 2024
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin
Classification: Class II
Class II RecallMay 2024
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin
Classification: Class II
Class II RecallApr 2024
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryla
Classification: Class II
Class II RecallFeb 2024
Lupin Pharmaceuticals Inc.
Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bott
Classification: Class II
Class II RecallFeb 2024
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryla
Classification: Class II
Class II RecallFeb 2024
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore,
Classification: Class II
Class II RecallFeb 2024
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Marylan
Classification: Class II
Class II RecallJan 2024
Lupin Pharmaceuticals Inc.
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manu
Classification: Class II
Class II RecallDec 2023
Lupin Pharmaceuticals Inc.
Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD
Classification: Class II
Class I RecallAug 2023
Lupin Pharmaceuticals Inc.
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium
Classification: Class I
Class III RecallJul 2023
Lupin Pharmaceuticals Inc.
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Balti
Classification: Class III
Class III RecallFeb 2023
Lupin Pharmaceuticals Inc.
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Mar
Classification: Class III
Class II RecallJan 2023
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 212
Classification: Class II
Class II RecallDec 2022
Lupin Pharmaceuticals Inc.
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
Classification: Class II
Class II RecallDec 2022
Lupin Pharmaceuticals Inc.
Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
Classification: Class II
Class II RecallSep 2022
Lupin Pharmaceuticals Inc.
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Mar
Classification: Class II
Class II RecallAug 2022
Lupin Pharmaceuticals Inc.
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore,
Classification: Class II
Class II RecallJun 2022
Lupin Pharmaceuticals Inc.
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Balt
Classification: Class II
Class II RecallMay 2022
Lupin Pharmaceuticals Inc.
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-1
Classification: Class II
Class II RecallMay 2022
Lupin Pharmaceuticals Inc.
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378
Classification: Class II
Class II RecallMay 2022
Lupin Pharmaceuticals Inc.
Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-0
Classification: Class II
Class II RecallMay 2022
Lupin Pharmaceuticals Inc.
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-c
Classification: Class II
Class II RecallMay 2022
Lupin Pharmaceuticals Inc.
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-cou
Classification: Class II
Class II RecallMay 2022
Lupin Pharmaceuticals Inc.
Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-0
Classification: Class II
Class II RecallMay 2022
Lupin Pharmaceuticals Inc.
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-co
Classification: Class II
Class III RecallJan 2022
Lupin Pharmaceuticals Inc.
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775
Classification: Class III
Class III RecallJan 2022
Lupin Pharmaceuticals Inc.
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, In
Classification: Class III
Class III RecallDec 2021
Lupin Pharmaceuticals Inc.
Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium t
Classification: Class III
Class II RecallNov 2021
Lupin Pharmaceuticals Inc.
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-4
Classification: Class II
Class II RecallNov 2021
Lupin Pharmaceuticals Inc.
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
Classification: Class II
Class II RecallNov 2021
Lupin Pharmaceuticals Inc.
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Classification: Class II
Class II RecallNov 2021
Lupin Pharmaceuticals Inc.
Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Classification: Class II
Class II RecallNov 2021
Lupin Pharmaceuticals Inc.
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-4
Classification: Class II
Class III RecallNov 2021
Lupin Pharmaceuticals Inc.
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775
Classification: Class III