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Lupin Pharmaceuticals Recalls
122 recalls on record · April 24, 2013 to July 8, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 8, 2026DrugsFDA
Lupin Pharmaceuticals Inc. recalls Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe
Hazard: CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
July 8, 2026DrugsFDA
Lupin Pharmaceuticals Inc. recalls prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-3
Hazard: Presence of Foreign Substance
May 27, 2026DrugsFDA
Lupin Pharmaceuticals Inc. recalls Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, M
Hazard: Presence of particulate matter: a white thread-like structure in the cartridge
December 17, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc.,
Hazard: Defective container - seal not adhering to bottles
December 17, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Man
Hazard: Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
August 6, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceu
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
July 30, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida
Hazard: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
July 23, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals,
Hazard: Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
April 30, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc.
Hazard: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
January 8, 2025DrugsFDA
Lupin Pharmaceuticals Inc. recalls Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, I
Hazard: Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
November 27, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls 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
Hazard: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
November 27, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls 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-
Hazard: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
November 27, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls 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
Hazard: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
September 4, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Bal
Hazard: Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
June 26, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: L
Hazard: Failed Content Uniformity Specifications
June 5, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceutic
Hazard: Defective container: lack of seal integrity.
May 22, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin
Hazard: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
May 22, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin
Hazard: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
April 17, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryla
Hazard: Subpotent Drug
February 28, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bott
Hazard: Labeling: Incorrect or Missing Package Insert
February 7, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Marylan
Hazard: Subpotent Drug and Failed Impurities/Degradation Specifications
February 7, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryla
Hazard: Subpotent Drug and Failed Impurities/Degradation Specifications
February 7, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore,
Hazard: Failed Impurities/Degradation Specifications
January 17, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manu
Hazard: CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
December 20, 2023DrugsFDA
Lupin Pharmaceuticals Inc. recalls Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD
Hazard: Failed Dissolution Specifications
August 9, 2023DrugsFDA
Lupin Pharmaceuticals Inc. recalls Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium
Hazard: Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
July 19, 2023DrugsFDA
Lupin Pharmaceuticals Inc. recalls Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Balti
Hazard: Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
February 1, 2023DrugsFDA
Lupin Pharmaceuticals Inc. recalls Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Mar
Hazard: Subpotent Drug: Low assay result observed during long-term stability testing.
January 18, 2023DrugsFDA
Lupin Pharmaceuticals Inc. recalls Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 212
Hazard: Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
December 28, 2022DrugsFDA
Lupin Pharmaceuticals Inc. recalls Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
Hazard: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.