2026-07-08 · Class II · Ongoing
D-0723-2026 · Lupin Pharmaceuticals Inc.
Glucagon · CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Open attributed report →Official FDA enforcement snapshot
22 FDA enforcement reports across 5 report years, connected to 15 reviewed applications and 8 peptide profiles by exact application number.
Newest report dates
2026-07-08 · Class II · Ongoing
Glucagon · CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Open attributed report →2026-05-27 · Class II · Ongoing
Liraglutide · Presence of particulate matter: a white thread-like structure in the cartridge
Open attributed report →2026-05-13 · Class II · Ongoing
Octreotide · Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Open attributed report →2026-04-15 · Class II · Ongoing
Lanreotide · Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Open attributed report →2026-04-15 · Class II · Ongoing
Lanreotide · Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Open attributed report →2026-04-01 · Class II · Ongoing
Octreotide · Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Open attributed report →2026-04-01 · Class II · Ongoing
Octreotide · Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Open attributed report →2026-04-01 · Class II · Ongoing
Octreotide · Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Open attributed report →2026-01-21 · Class II · Ongoing
Lanreotide · Presence of Particulate Matter.
Open attributed report →2023-10-04 · Class III · Terminated
Leuprolide · Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
Open attributed report →2022-11-16 · Class I · Terminated
Octreotide · Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Open attributed report →2022-05-25 · Class II · Completed
Dulaglutide · TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
Open attributed report →2021-09-01 · Class II · Terminated
Dulaglutide · Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Open attributed report →2021-06-02 · Class II · Terminated
Linaclotide · CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Open attributed report →2021-06-02 · Class II · Terminated
Semaglutide · CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Open attributed report →2021-04-21 · Class II · Terminated
Liraglutide · Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Open attributed report →2021-04-21 · Class II · Terminated
Liraglutide · Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Open attributed report →2014-05-07 · Class II · Terminated
Leuprolide · Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Open attributed report →2014-05-07 · Class II · Terminated
Leuprolide · Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Open attributed report →2014-05-07 · Class II · Terminated
Leuprolide · Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Open attributed report →2014-05-07 · Class II · Terminated
Leuprolide · Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device.
Open attributed report →2014-05-07 · Class II · Terminated
Leuprolide · Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device.
Open attributed report →