Brand
Lupin Pharmaceuticals Inc. Recalls
119 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Lupin Pharmaceuticals Inc..
119Total Recalls
5Critical
12.4MUnits Affected
Nov 13, 2025Most Recent
All Recalls
Every Lupin Pharmaceuticals Inc. Recall
Sorted by most recent. Click any recall for full details.
119 recalls
High RiskFDA
Lupin Pharmaceuticals Inc.
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lu...
Injectable Drugs32,736 affectedNov 13, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108...
Oral Drugs52,128 affectedNov 5, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Nap...
Oral Drugs7,668 affectedJul 2, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 6818...
Oral Drugs2,724 affectedJun 27, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, ...
Oral Drugs58,968 affectedJun 20, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 2...
Oral Drugs2,724 affectedApr 10, 2025
High RiskFDA
Lupin Pharmaceuticals Inc.
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Ma...
Oral Drugs480 affectedDec 20, 2024
High RiskFDA
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 68180-591-02) bottles,...
Oral Drugs357,414 affectedOct 23, 2024
High RiskFDA
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 68180-589-02) bottles...
Oral Drugs112,770 affectedOct 23, 2024
High RiskFDA
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 68180-590-02) bottles, ...
Oral Drugs146,322 affectedOct 23, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland ...
Oral Drugs4,554 affectedAug 21, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceutic...
Oral Drugs3,552 affectedMay 30, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltim...
Oral Drugs51,006 affectedMay 8, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, ...
Oral Drugs17,070 affectedApr 24, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, ...
Oral Drugs17,040 affectedApr 24, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufac...
Oral Drugs26,352 affectedMar 21, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the...
Oral Drugs0 affectedFeb 5, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United S...
Oral Drugs15,576 affectedJan 5, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United St...
Oral Drugs16,560 affectedJan 5, 2024
High RiskFDA
Lupin Pharmaceuticals Inc.
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, ...
Oral Drugs4,608 affectedJan 3, 2024
High RiskFDA
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, Manufactured for: Lup...
Oral Drugs100 affectedDec 20, 2023
High RiskFDA
Lupin Pharmaceuticals Inc.
Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactur...
Oral Drugs0 affectedNov 22, 2023
RecallFDA
Lupin Pharmaceuticals Inc.
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21...
Oral Drugs3,096 affectedJun 27, 2023
CriticalFDA
Lupin Pharmaceuticals Inc.
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg...
Oral Drugs4,179 affectedJun 23, 2023
RecallFDA
Lupin Pharmaceuticals Inc.
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manu...
Topical Drugs5,720 affectedJan 20, 2023
High RiskFDA
Lupin Pharmaceuticals Inc.
Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured ...
Oral Drugs16,056 affectedDec 12, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limit...
Oral Drugs23,736 affectedDec 7, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limit...
Oral Drugs30,612 affectedDec 7, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manu...
Oral Drugs11,802 affectedSep 13, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: ...
Oral Drugs7,872 affectedJul 28, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 b...
Oral Drugs3,216 affectedJun 10, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Oral Drugs26,910 affectedApr 27, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Ma...
Oral Drugs1,247,067 affectedMar 31, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manu...
Oral Drugs1,466,150 affectedMar 31, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC...
Oral Drugs2,361,924 affectedMar 31, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# ...
Oral Drugs303,696 affectedMar 31, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manu...
Oral Drugs657,336 affectedMar 31, 2022
High RiskFDA
Lupin Pharmaceuticals Inc.
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC#...
Oral Drugs1,214,016 affectedMar 31, 2022
RecallFDA
Lupin Pharmaceuticals Inc.
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD ...
Oral Drugs23,965 affectedDec 29, 2021
RecallFDA
Lupin Pharmaceuticals Inc.
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 6818...
Ophthalmic Drugs50,832 affectedDec 22, 2021
RecallFDA
Lupin Pharmaceuticals Inc.
Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg)...
Oral Drugs4,113 affectedNov 19, 2021
RecallFDA
Lupin Pharmaceuticals Inc.
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 6818...
Ophthalmic Drugs16,272 affectedOct 20, 2021
High RiskFDA
Lupin Pharmaceuticals Inc.
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, R...
Oral Drugs98,052 affectedOct 12, 2021
High RiskFDA
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
Oral Drugs134,016 affectedOct 12, 2021
High RiskFDA
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
Oral Drugs119,544 affectedOct 12, 2021
High RiskFDA
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
Oral Drugs51,144 affectedOct 12, 2021
High RiskFDA
Lupin Pharmaceuticals Inc.
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, R...
Oral Drugs63,408 affectedOct 12, 2021
High RiskFDA
Lupin Pharmaceuticals Inc.
Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNit...
Oral Drugs1,902 affectedOct 8, 2021