FDA Drug Recalls

70 recalls · Class III, newest first

Class III · Low risk Terminated Dec 12, 2023

ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total)…

Reason Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification

GlaxoSmithKline LLC NDC 0173-0869-10 D-0160-2024

Class III · Low risk Terminated Dec 8, 2023

Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA…

Reason Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine…

Azurity Pharmaceuticals, Inc. NDC 52652-9001-1 D-0213-2024

Class III · Low risk Terminated Nov 22, 2023

buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical…

Reason Failed Dissolution Specifications

Sun Pharmaceutical Industries INC NDC 47335-738-86 D-0137-2024

Class III · Low risk Terminated Nov 10, 2023

Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceuticals USA…

Reason OOS for viscosity

Teva Pharmaceuticals USA, Inc NDC 0591-2926-30 D-0127-2024

Class III · Low risk Terminated Nov 9, 2023

LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe…

Reason Product Mix-up: Incorrect Product Formulation

Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop NDC 73271-1003-1 D-0140-2024

Class III · Low risk Terminated Nov 6, 2023

Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc…

Reason Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established…

Taro Pharmaceuticals Inc. NDC 51672-3007-1 D-0089-2024

Class III · Low risk Terminated Oct 30, 2023

V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd…

Reason Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated…

Grato Holdings, Inc. D-0099-2024

Class III · Low risk Terminated Oct 27, 2023

Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC…

Reason Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots

NCS Healthcare of Kentucky Inc NDC 0615-7718-05 D-0114-2024

Class III · Low risk Terminated Oct 27, 2023

Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC…

Reason Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots

NCS Healthcare of Kentucky Inc NDC 0615-7718-05 D-0113-2024

Class III · Low risk Terminated Oct 26, 2023

Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771…

Reason Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.

VistaPharm LLC NDC 66689-307-08 D-0093-2024

Class III · Low risk Terminated Oct 23, 2023

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count…

Reason Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18…

Glenmark Pharmaceuticals Inc., USA NDC 68462-390-30 D-0112-2024

Class III · Low risk Terminated Oct 20, 2023

Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark…

Reason Failed Impurities/Degradation Specifications

Glenmark Pharmaceuticals Inc., USA NDC 68462-879-01 D-0085-2024

Class III · Low risk Terminated Oct 20, 2023

Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured…

Reason Subpotent Drug

Edenbridge Pharmaceuticals, LLC NDC 42799-217-01 D-0080-2024

Class III · Low risk Terminated Oct 17, 2023

Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for…

Reason Failed Excipient Specifications: high content of ethylene glycol (EG)

VistaPharm LLC NDC 66689-330-08 D-0126-2024

Class III · Low risk Terminated Oct 4, 2023

VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd…

Reason Labeling: Not Elsewhere Classified

Denver Solutions, LLC DBA Leiters Health NDC 71449-029-68 D-0072-2024

Class III · Low risk Terminated Oct 4, 2023

VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd…

Reason Labeling: Not Elsewhere Classified

Denver Solutions, LLC DBA Leiters Health NDC 71449-028-68 D-0071-2024

Class III · Low risk Terminated Oct 4, 2023

Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health…

Reason Labeling: Not Elsewhere Classified

Denver Solutions, LLC DBA Leiters Health NDC 71449-157-70 D-0070-2024

Class III · Low risk Terminated Oct 4, 2023

Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical…

Reason Failed Dissolution Specifications

Sun Pharmaceutical Industries INC NDC 47335-737-86 D-0044-2024

Class III · Low risk Terminated Oct 3, 2023

Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not…

Reason Subpotent: Failing Test Results for Epinephrine

Imprimis NJOF, LLC NDC 71384-640-01 D-0040-2024

Class III · Low risk Terminated Sep 20, 2023

MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%…

Reason Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.

Imprimis NJOF, LLC D-0043-2024

Class III · Low risk Terminated Sep 12, 2023

Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use…

Reason Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.

Tolmar, Inc. NDC 62935-753-75 D-1178-2023

Class III · Low risk Terminated Sep 7, 2023

Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only…

Reason Subpotent: Out of Specification result observed for low assay

Sun Pharmaceutical Industries INC NDC 47335-506-96 D-1172-2023

Class III · Low risk Terminated Sep 5, 2023

Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%…

Reason Incorrect/Undeclared Excipients.

Vi-Jon, LLC D-1173-2023

Class III · Low risk Terminated Sep 1, 2023

HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health…

Reason Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.

Amerisource Health Services LLC D-0039-2024

Class III · Low risk Terminated Aug 29, 2023

Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in case of 6…

Reason Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.

RB Health (US) LLC NDC 63824-431-90 D-1179-2023