Drug Recalls

Drug Recall Results

ICU Medical – 20 mEq Potassium Chloride Injection

Date: 11/03/2025
Company: Otsuka ICU Medical LLC
Dosage Form: Injection
Recall Issue Type: Labeling / Packaging
Recall Reason: Potential for Potassium chloride overdose: 20 mEq Potassium Chloride Injection is Mislabeled As 10 mEq Potassium Chloride Injection

Green Lumber – Dietary Supplement

Date: 08/29/2025
Company: Green Lumber Holding, LLC.
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared prescription drug-Tadalafil

DermaRite – Hand Sanitizers, Cleansers, Skin Protectants, Deodorant

Date: 08/28/2025
Company: DermaRite Industries
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Device & Drug Safety - Potential Burkholderia cepacian contamination

Unichem Pharmaceuticals – Cyclobenzaprine Hydrochloride Tablets USP 10 mg

Date: 08/27/2025
Company: Unichem Pharmaceuticals
Dosage Form: Tablet
Recall Issue Type: Labeling / Packaging
Recall Reason: Device & Drug Safety – Mislabel

B. Braun – Lactated Ringer’s Injection USP 1000 mL/0.9% Sodium Chloride Injection USP 1000 mL

Date: 08/19/2025
Company: B. Braun Medical, Inc.
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Due to the presence of particulate matter.

DermaKleen, Dermasarra, Kleenfoam, and Perigiene – OTC antiseptic lotion soaps, external analgesics, antimicrobial foam soaps, and antiseptic cleansers

Date: 08/09/2025
Company: DermaRite Industries, LL
Dosage Form: Topical
Recall Issue Type: Contamination / Sterility
Recall Reason: Contamination with Burkholderia cepacia

Nostrum Laboratories – Sucralfate Tablets USP 1 gram

Date: 07/14/2025
Company: Nostrum Laboratories, Inc.
Dosage Form: Tablet
Recall Issue Type: Other Recall Issue
Recall Reason: Company closure and discontinuation of quality activities.

Sandoz – Cefazolin for Injection, USP, 1 gm vial

Date: 06/27/2025
Company: Sandoz Inc.
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Potential Presence of Penicillin G Potassium Injection Vial

Zicam® and Orajel™ – Cold Remedy Nasal Swabs, Nasal AllClear Swabs, Baby Teething Swabs

Date: 06/06/2025
Company: Church & Dwight Co., Inc.
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Microbial contamination

Amneal – Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg

Date: 06/04/2025
Company: Amneal Pharmaceutical LLC
Dosage Form: Tablet
Recall Issue Type: Contamination / Sterility
Recall Reason: Microbial contamination

UNAVY & UMOVY – Unavy Acidio Hialuronico (30 caplets/850 mg) and Umovy Acidio Hialuronico (30 caplets/850 mg)

Date: 05/22/2025
Company: UMARY USA
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: The product contains undeclared Dexamethasone, Diclofenac and Omeprazole

Endurance Boost – Dietary supplement for male performance and energy

Date: 05/06/2025
Company: EnShiShiXiangNiShangMaoYouXianGongSi
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Propoxyphenylsildenafil, Sildenafil

Amneal Pharmaceuticals LLC. – Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag

Date: 04/18/2025
Company: Amneal Pharmaceuticals LLC.
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Product may contain an inert fiber identified as polypropylene fibers from the IV bag

Dr. Reddy’s – Levetiracetam in Sodium Chloride Injection

Date: 03/13/2025
Company: Dr. Reddy’s Laboratories Ltd.
Dosage Form: Injection
Recall Issue Type: Labeling / Packaging
Recall Reason: Mislabeling of infusion bag

Vitality – Vitality male enhancement dietary supplement capsules

Date: 03/03/2025
Company: One Source Nutrition
Dosage Form: Capsule
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Sildenafil and Tadalafil

Natural Dior LLC – Dietary Supplement

Date: 02/26/2025
Company: Natural Dior LLC
Dosage Form: Other / Unspecified
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Tadalafil

SinuCleanse – Soft Tip Squeeze Bottle Nasal Wash System

Date: 02/25/2025
Company: Ascent Consumer Products Inc.
Dosage Form: Other / Unspecified
Recall Issue Type: Contamination / Sterility
Recall Reason: Microbial contamination of the product with Staphylococcus aureus (S. aureus)

Vitality – Vitality male enhancement dietary supplement capsules

Date: 02/20/2025
Company: One Source Nutrition
Dosage Form: Capsule
Recall Issue Type: Undeclared / Unapproved Ingredient
Recall Reason: Undeclared Sildenafil and Tadalafil

Provepharm Inc. – Phenylephrine hydrochloride Injection, USP, 10 mg/ mL

Date: 01/24/2025
Company: Provepharm Inc.
Dosage Form: Injection
Recall Issue Type: Other Recall Issue
Recall Reason: Device & Drug Safety – Potential Foreign Material

Astellas – Tacrolimus and Tacrolimus Extended-Release capsules

Date: 12/24/2024
Company: Astellas Pharma US, Inc.
Dosage Form: Capsule
Recall Issue Type: Other Recall Issue
Recall Reason: Bottles may contain empty capsules.