Lupin Pharmaceuticals Inc. recalls
19 recalls on record · 1 rated Critical · FDA
Every recall we have on record for Lupin Pharmaceuticals Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
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
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only,…
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, …
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.
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 unapproved vendor
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral…
Failed Content Uniformity Specifications
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only,…
Defective container: lack of seal integrity.
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx…
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin…
Subpotent Drug and Failed Impurities/Degradation Specifications
Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin…
Failed Dissolution Specifications
Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03…
Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for:…
Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals,…
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin…
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin…
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for…
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b)…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b)…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin…
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.