Lupin Pharmaceuticals Inc.

Complete recall history across all FDA and CPSC categories, 119 total recalls

Lupin Pharmaceuticals Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (119)

FDA drug safety enforcement actions by Lupin Pharmaceuticals Inc.. Showing most recent 50.

Date Product Reason Class
Jun 23, 2026 Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg p... CGMP deviation: OOS result observed for the Gliding Force functionality test ... Class II
Jun 4, 2026 prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 m... Presence of Foreign Substance Class II
Apr 24, 2026 Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin... Presence of particulate matter: a white thread-like structure in the cartridge Class II
Nov 13, 2025 Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syr... Failed impurities/degradation specifications: out of specification results fo... Class II
Nov 5, 2025 Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Ma... Defective container - seal not adhering to bottles Class II
Jul 2, 2025 Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle,... Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expir... Class II
Jun 27, 2025 clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelica... Failed Impurities/Degradation Specifications: an out of specification result ... Class II
Jun 20, 2025 Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles... Product Mix Up: This product is being recalled because of a complaint receive... Class II
Apr 10, 2025 clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Ma... Failed Impurities/Degradation Specifications: an out of specification result ... Class II
Dec 20, 2024 Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only,... Failed Impurities/Degradation Specifications: Out of specifications result ob... Class II
Oct 23, 2024 Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC ... CGMP Deviations: Active pharmaceutical ingredient was sourced from an unappro... Class II
Oct 23, 2024 Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count ND... CGMP Deviations: Active pharmaceutical ingredient was sourced from an unappro... Class II
Oct 23, 2024 Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC... CGMP Deviations: Active pharmaceutical ingredient was sourced from an unappro... Class II
Aug 21, 2024 Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufac... Subpotent Drug- An out of specification ( OOS ) result observed in assay test... Class II
May 30, 2024 Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for or... Failed Content Uniformity Specifications Class II
May 8, 2024 Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx... Defective container: lack of seal integrity. Class II
Apr 24, 2024 Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 m... Presence of foreign substance: Product complaint of foreign material in recon... Class II
Apr 24, 2024 Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 m... Presence of foreign substance: Product complaint of foreign material in recon... Class II
Mar 21, 2024 Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lu... Subpotent Drug Class II
Feb 5, 2024 Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when rec... Labeling: Incorrect or Missing Package Insert Class II
Jan 5, 2024 Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lup... Subpotent Drug and Failed Impurities/Degradation Specifications Class II
Jan 5, 2024 Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lu... Subpotent Drug and Failed Impurities/Degradation Specifications Class II
Jan 3, 2024 Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured f... Failed Impurities/Degradation Specifications Class II
Dec 20, 2023 Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 coun... CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the accepta... Class II
Nov 22, 2023 Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for... Failed Dissolution Specifications Class II
Jun 27, 2023 Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufact... Subpotent Drug: Out-of-Specification test results observed in assay test at 2... Class III
Jun 23, 2023 Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 m... Failed Stability Specification and Failed Impurities/Degradation Specificatio... Class I
Jan 20, 2023 Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for:... Subpotent Drug: Low assay result observed during long-term stability testing. Class III
Dec 12, 2022 Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lu... Failed Impurities/Degradation Specifications: Failure observed in related sub... Class II
Dec 7, 2022 Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptab... Class II
Dec 7, 2022 Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptab... Class II
Sep 13, 2022 Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for:... Presence of Foreign Substance: Foreign material (metal piece) embedded in one... Class II
Jul 28, 2022 Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured ... CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP... Class II
Jun 10, 2022 Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufac... Failed Dissolution Specifications: Out of specification test results observed... Class II
Apr 27, 2022 GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solut... Failed Stability Specification Class II
Mar 31, 2022 Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II
Mar 31, 2022 Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II
Mar 31, 2022 Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-c... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II
Mar 31, 2022 Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II
Mar 31, 2022 Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II
Mar 31, 2022 Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II
Dec 29, 2021 Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, ... Out-of-specification impurity test result observed at 18-month long term stab... Class III
Dec 22, 2021 Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... Failed Stability Specifications: Out-of-specification results observed in a w... Class III
Nov 19, 2021 Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/... Subpotent Drug Class III
Oct 20, 2021 Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... Failed Stability Specifications: Out-of-specification results observed in a w... Class III
Oct 12, 2021 Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC... CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class II
Oct 12, 2021 Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count... CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class II
Oct 12, 2021 Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 coun... CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class II
Oct 12, 2021 Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 coun... CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class II
Oct 12, 2021 Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC... CGMP Deviations: impurity N-nitrosoirbesartan detected in API Class II

View all 119 drug recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious, there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious, the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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