Peptide Regulatory News

Latest updates on FDA actions, state regulations, legal cases, and international developments affecting peptide laws.

Recall June 23, 2026

Glucagon Emergency Kit Recalled (Class II) Over Stability Test Failure

Lupin Pharmaceuticals recalled Glucagon Emergency Kit vials as a Class II action after an out-of-specification stability test result, effective June 23, 2026.

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Recall April 24, 2026

Liraglutide Injection Recalled (Class II) Over Particulate Matter

Lupin Pharmaceuticals initiated a Class II recall of Liraglutide Injection on April 24, 2026, citing a white thread-like particulate found in cartridges.

Recall April 8, 2026

Desmopressin Nasal Spray Recalled (Class II) Over Bottle Cap Defect

Apotex Corp. initiated a Class II recall of Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL on April 8, 2026, citing defective bottle cap liners.

Recall February 9, 2026

Cetrorelix Acetate Injection Kit Recalled (Class II) Over Needle Defect

Meitheal Pharmaceuticals initiated a Class II recall of Cetrorelix Acetate for Injection Kits on Feb 9, 2026, citing missing or duplicated needles in the kits.

Recall November 13, 2025

Ganirelix Acetate Injection Recalled: Class II, Impurity Issue

Lupin Pharmaceuticals initiated a Class II recall of Ganirelix Acetate Injection on Nov 13, 2025 due to an out of specification impurity result.

Recall May 13, 2024

Vasopressin Injection Recalled by American Regent (Class II)

American Regent recalled Vasopressin Injection, USP in a Class II action initiated May 13, 2024, citing subpotency and impurity test results.

Recall March 12, 2024

HUMALOG (Insulin Lispro) Recalled in Class II FDA Action

Eli Lilly & Company initiated a Class II recall of HUMALOG U-100 insulin lispro injection on March 12, 2024, citing CGMP deviations. Status: Completed.

Recall February 6, 2024

Terlivaz (Terlipressin) Recalled in Class II Action Over Temperature Excursion

Mallinckrodt initiated a Class II recall of Terlivaz (terlipressin) on Feb 6, 2024, citing a temperature excursion from a shipping delay to the distributor.

Recall September 12, 2023

ELIGARD (Leuprolide) Recall Classified Class III, Status Terminated

Tolmar, Inc. recalled ELIGARD (leuprolide acetate) on 20230912 as a Class III event over superpotent drug levels. Status is terminated.

Recall April 26, 2023

Calcitonin Salmon Nasal Spray Recalled (Class II) Over Glass Splinter

Apotex Corp. recalled Calcitonin Salmon Nasal Spray in a Class II action after a glass splinter in the pump ball seat made the pump inoperable.

Recall April 19, 2023

Fyremadel (ganirelix acetate) Recalled in Class II Action

Sun Pharmaceutical Industries Ltd. initiated a Class II recall of Fyremadel (ganirelix acetate) on April 19, 2023 due to particulate matter.

Recall November 23, 2022

Desmopressin Acetate Tablets Recalled (Class II) Over Subpotency

A Class II recall of Desmopressin Acetate Tablets 0.2mg was initiated on Nov 23, 2022 by Heritage Pharmaceuticals due to subpotent drug levels.

Recall April 13, 2022

Kinevac (Sincalide) Recall Classified Class II for Temperature Abuse

A Class II recall of Kinevac (Sincalide for Injection) was initiated April 13, 2022, citing cGMP temperature abuse deviations. The recall status is terminated.

Recall April 5, 2022

Trulicity (Dulaglutide) Class II Recall Over Temperature Abuse

Cardinal Health Inc. initiated a Class II recall of Trulicity (dulaglutide) on April 5, 2022, citing temperature abuse during storage. Status: Completed.

Recall August 19, 2021

Trulicity Recalled (Class II) Over Autoinjector Labeling Error

Eli Lilly recalled Trulicity (dulaglutide) pens in a Class II action due to a label error on declared strength, initiated August 19, 2021.

Recall March 22, 2021

Saxenda (Liraglutide) Class II Recall Over Temperature Abuse

Novo Nordisk recalled Saxenda (liraglutide) samples in a Class II action initiated March 22, 2021, citing temperature abuse during storage.

Recall March 22, 2021

Victoza Recall Classified Class II Over Temperature Storage Issue

A Class II recall of Victoza (liraglutide) was initiated on March 22, 2021, by Novo Nordisk Inc over temperature abuse concerns during storage.

Recall March 15, 2021

Linzess (linaclotide) Class II Recall Over Temperature Excursion

Cardinal Health Inc. initiated a Class II recall of Linzess (linaclotide) capsules on March 15, 2021 due to storage temperature excursion. Status: terminated.

Recall March 15, 2021

Semaglutide (Rybelsus) Class II Recall Initiated March 2021

FDA recall record shows a Class II action for Rybelsus (semaglutide) 7 mg tablets, initiated March 15, 2021, over storage temperature deviations. Status: terminated.

Recall June 29, 2020

Cetrotide (Cetrorelix) Recalled: Class II, Defective Vial Stoppers

EMD Serono initiated a Class II recall of Cetrotide (cetrorelix acetate) on June 29, 2020, citing missing rubber stoppers on drug vials.

Recall March 10, 2014

Lupron Depot Recall: Class II Action Over Syringe Device Defect

AbbVie initiated a Class II recall of Lupron Depot (leuprolide acetate) kits on March 10, 2014, citing a defective needle stick protection device. Status: terminated.