Peptide Regulatory News

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

Recall August 6, 2026

Acthar Gel (Corticotropin) Recalled: Class II, Particulate Matter Found

Mallinckrodt initiated a Class II recall of Acthar Gel on Aug 6, 2026, citing particulate matter including glass and stopper pieces in vials.

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Recall August 6, 2026

Vasopressin Injection Recalled by Baxter Over CGMP Deviations

Baxter Healthcare recalled Vasopressin in 0.9% Sodium Chloride Injection on Aug 6, 2026, a Class II recall citing CGMP deviations. Status is ongoing.

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.

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 24, 2026

Octreotide Acetate Injectable Suspension Recalled (Class II)

Teva initiated a Class II recall of Octreotide Acetate for Injectable Suspension on April 24, 2026, citing lack of assurance of sterility.

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 March 17, 2026

Octreotide Acetate Injection Recalled (Class II) Over Sterility Concerns

Teva Pharmaceuticals initiated a Class II recall of Octreotide Acetate for Injectable Suspension on March 17, 2026, citing sterility assurance issues.

Recall March 17, 2026

Octreotide Acetate Injectable Suspension Recalled (Class II)

Teva Pharmaceuticals initiated a Class II recall of Octreotide Acetate for Injectable Suspension on March 17, 2026, citing lack of sterility assurance.

Recall March 17, 2026

Octreotide Acetate Injectable Suspension Recalled (Class II) by Teva

Teva Pharmaceuticals initiated a Class II recall of Octreotide Acetate for Injectable Suspension on March 17, 2026, citing lack of sterility assurance.

Recall March 13, 2026

Lanreotide Injection Recalled (Class II) Over Sterility Assurance Concern

Cipla USA recalled Lanreotide Injection 120 mg/0.5 mL as a Class II action, citing lack of assurance of sterility from an FDA site observation.

Recall March 13, 2026

Lanreotide Acetate Injection Recalled by Cipla USA (Class II)

Cipla USA initiated a Class II recall of Lanreotide Acetate Injection on March 13, 2026, citing lack of assurance of sterility at a contract site.

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 January 2, 2026

Lanreotide Injection Recalled (Class II) Over Particulate Matter

Cipla USA initiated a Class II recall of Lanreotide Injection 120 mg/0.5 mL on Jan 2, 2026, citing presence of particulate matter. Recall is ongoing.

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 February 6, 2024

Acthar Gel (Corticotropin) Class II Recall Over Temperature Excursion

Mallinckrodt Hospital Products initiated a Class II recall of Acthar Gel on Feb 6, 2024 due to a shipping temperature excursion, a cGMP deviation.

Recall January 11, 2024

Vasostrict (Vasopressin) Class II Recall Initiated January 2024

Par Sterile Products LLC initiated a Class II recall of Vasostrict (vasopressin) on January 11, 2024, citing superpotent assay results.

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 July 3, 2023

Bivalirudin for Injection 250 mg Recalled (Class II) Over Particulate Matter

Accord Healthcare initiated a Class II recall of Bivalirudin for Injection 250 mg on July 3, 2023, citing fiber particulate matter. The recall has been terminated.