Drug and pharmaceutical recalls

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Subpotent Drug

Lack of Assurance of Sterility

Failed Tablet/Capsule Specifications

FOR IMMEDIATE RELEASE – 03/30/2026 - Flushing, New York, Aphreseller (Ebay seller ID), Buy-herbal.com is recalling all lots of Kian Pee Wan capsules to the consumer level. FDA analysis has found that the product contains the undeclared drug ingredients dexamethasone and cyproheptadine. Products cont

Lack of Assurance of Sterility

Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.

Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg

Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.

Bridgewater, New Jersey, Amneal Pharmaceuticals LLC is voluntarily recalling one lot of Magnesium Sulfate in Water for Injection, USP, 4g/100mL, IV bag, to the hospital level. A Magnesium Sulfate in Water for Injection pouch was found to contain an IV bag of Tranexamic Acid in 0.7% Sodium Chloride I

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

Failed Dissolution Specifications

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil

Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Lack of Assurance of Sterility

Presence of Particulate Matter: Due to production issues

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.

Stability Data Does Not Support Expiry Date.

Stability Data Does Not Support Expiry Date.

Stability Data Does Not Support Expiry Date.

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

Defective container; inadequately sealed blister packaging.

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution