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Lupin Pharmaceuticals Inc. FDA Recalls
55 recalls on file across drugs, 1 of them Class I and 7 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34Class IIAug 3, 2026Failed content uniformity specifications. |
| Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringeClass IIJun 23, 2026CGMP deviation: OOS result observed for the Gliding Force fu |
| prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-3Class IIJun 4, 2026Presence of Foreign Substance |
| Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, MClass IIApr 24, 2026Presence of particulate matter: a white thread-like structur |
| Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, ManClass IINov 13, 2025Failed impurities/degradation specifications: out of specifi |
| Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc.,Class IINov 5, 2025Defective container - seal not adhering to bottles |
| Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin PharmaceuClass IIJul 2, 2025Labeling: Incorrect or Missing Lot and/or Exp Date: released |
| clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, FloridaClass IIJun 27, 2025Failed Impurities/Degradation Specifications: an out of spec |
| Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals,Class IIJun 20, 2025Product Mix Up: This product is being recalled because of a |
| clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc.Class IIApr 10, 2025Failed Impurities/Degradation Specifications: an out of spec |
| Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, IClass IIDec 20, 2024Failed Impurities/Degradation Specifications: Out of specifi |
| 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 6818Class IIOct 23, 2024CGMP Deviations: Active pharmaceutical ingredient was source |
| Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180Class IIOct 23, 2024CGMP Deviations: Active pharmaceutical ingredient was source |
| 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-Class IIOct 23, 2024CGMP Deviations: Active pharmaceutical ingredient was source |
| Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., BalClass IIAug 21, 2024Subpotent Drug- An out of specification ( OOS ) result obser |
| Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: LClass IIMay 30, 2024Failed Content Uniformity Specifications |
| Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin PharmaceuticClass IIMay 8, 2024Defective container: lack of seal integrity. |
| Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Class IIApr 24, 2024Presence of foreign substance: Product complaint of foreign |
| Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Class IIApr 24, 2024Presence of foreign substance: Product complaint of foreign |
| Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MarylaClass IIMar 21, 2024Subpotent Drug |
| Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottClass IIFeb 5, 2024Labeling: Incorrect or Missing Package Insert |
| Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MarylaClass IIJan 5, 2024Subpotent Drug and Failed Impurities/Degradation Specificati |
| Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MarylanClass IIJan 5, 2024Subpotent Drug and Failed Impurities/Degradation Specificati |
| Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore,Class IIJan 3, 2024Failed Impurities/Degradation Specifications |
| Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, ManuClass IIDec 20, 2023CGMP Deviations: N-Nitroso Desloratadine impurity result exc |
| Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MDClass IINov 22, 2023Failed Dissolution Specifications |
| Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. BaltiClass IIIJun 27, 2023Subpotent Drug: Out-of-Specification test results observed i |
| Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calciumClass IJun 23, 2023Failed Stability Specification and Failed Impurities/Degrada |
| Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MarClass IIIJan 20, 2023Subpotent Drug: Low assay result observed during long-term s |
| Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 212Class IIDec 12, 2022Failed Impurities/Degradation Specifications: Failure observ |
| Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202Class IIDec 7, 2022CGMP Deviations: Detection of N-Nitroso-quinapril impurity a |
| Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202Class IIDec 7, 2022CGMP Deviations: Detection of N-Nitroso-quinapril impurity a |
| Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MarClass IISep 13, 2022Presence of Foreign Substance: Foreign material (metal piece |
| Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore,Class IIJul 28, 2022CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitros |
| Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., BaltClass IIJun 10, 2022Failed Dissolution Specifications: Out of specification test |
| GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-1Class IIApr 27, 2022Failed Stability Specification |
| Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-coClass IIMar 31, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-0Class IIMar 31, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-0Class IIMar 31, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-cClass IIMar 31, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378Class IIMar 31, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-couClass IIMar 31, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, InClass IIIDec 29, 2021Out-of-specification impurity test result observed at 18-mon |
| Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775Class IIIDec 22, 2021Failed Stability Specifications: Out-of-specification result |
| Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tClass IIINov 19, 2021Subpotent Drug |
| Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775Class IIIOct 20, 2021Failed Stability Specifications: Out-of-specification result |
| Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-4Class IIOct 12, 2021CGMP Deviations: impurity N-nitrosoirbesartan detected in AP |
| Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx onlyClass IIOct 12, 2021CGMP Deviations: impurity N-nitrosoirbesartan detected in AP |
| Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx onlyClass IIOct 12, 2021CGMP Deviations: impurity N-nitrosoirbesartan detected in AP |
| Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-4Class IIOct 12, 2021CGMP Deviations: impurity N-nitrosoirbesartan detected in AP |
| Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx onlyClass IIOct 12, 2021CGMP Deviations: impurity N-nitrosoirbesartan detected in AP |
| Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MaClass IIOct 8, 2021Out of specification result observed in a dissolution test a |
| Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. BaClass IIApr 29, 2021Subpotent Drug |
| Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (whClass IIMar 26, 2021Superpotent Drug |
| Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Class IIIJan 21, 2021Failed Impurities/Degradation Specifications; Out-of-specifi |