April 9, 2025DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distr
Hazard: Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
April 2, 2025DrugsFDA
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenou
Hazard: Lack of Assurance of Sterility
April 2, 2025DrugsFDA
Consumer Product Partners, LLC recalls [CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INC
Hazard: Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
April 2, 2025DrugsFDA
Ascent Consumer Products Inc. recalls SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-coun
Hazard: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
April 2, 2025DrugsFDA
Ascent Consumer Products Inc. recalls SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash Syste
Hazard: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
April 2, 2025DrugsFDA
Ascent Consumer Products Inc. recalls SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 3
Hazard: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
April 2, 2025DrugsFDA
Johnson, S C and Son, Inc recalls babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 8100
Hazard: Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
April 2, 2025DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FS
Hazard: Lack of Assurance of Sterility
April 2, 2025DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CA
Hazard: Lack of Assurance of Sterility
April 2, 2025DrugsFDA
QuVa Pharma, Inc. recalls fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FS
Hazard: Lack of Assurance of Sterility
April 2, 2025DrugsFDA
Strides Pharma, Inc. recalls Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Bruns
Hazard: Presence of foreign substance: Presence of Benzene.
April 2, 2025DrugsFDA
Strides Pharma, Inc. recalls Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Br
Hazard: Presence of foreign substance: Presence of Benzene.
April 2, 2025DrugsFDA
A-S Medication Solutions LLC recalls METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60
Hazard: Presence of Foreign Tablets/Capsules.
March 26, 2025DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablet
Hazard: Super-Potent Drug: Out of specification potency results were obtained.
March 26, 2025DrugsFDA
Mylan Institutional, Inc. recalls Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets
Hazard: Super-Potent Drug: Out of specification potency results were obtained.
March 26, 2025DrugsFDA
MEDLINE INDUSTRIES, LP - Northfield recalls CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manuf
Hazard: Subpotent Drug
March 26, 2025DrugsFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manuf
Hazard: Subpotent Drug
March 26, 2025DrugsFDA
Golden State Medical Supply Inc. recalls PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-3
Hazard: Failed Dissolution Specifications
March 26, 2025DrugsFDA
Amgen, Inc. recalls Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous o
Hazard: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
March 26, 2025DrugsFDA
Amgen, Inc. recalls Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use O
Hazard: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
March 26, 2025DrugsFDA
Fruit Of The Earth, Inc. recalls CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
Hazard: Chemical contamination: presence of benzene
March 26, 2025DrugsFDA
Fruit Of The Earth, Inc. recalls Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a c
Hazard: Chemical contamination: presence of benzene
March 26, 2025DrugsFDA
FDC Limited recalls Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LL
Hazard: Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
March 26, 2025DrugsFDA
One Source Nutrition, Inc, recalls Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle,
Hazard: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
March 26, 2025DrugsFDA
MYLAN PHARMACEUTICALS INC recalls Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265
Hazard: Failed Dissolution Specifications - low dissolution results
March 26, 2025DrugsFDA
Slate Run Pharmaceuticals recalls Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 4321
Hazard: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
March 26, 2025DrugsFDA
Slate Run Pharmaceuticals recalls Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 4321
Hazard: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
March 26, 2025DrugsFDA
Rising Pharma Holding, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
March 19, 2025DrugsFDA
Johnson, S C and Son, Inc recalls Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ
Hazard: Chemical Contamination
March 19, 2025DrugsFDA
Johnson, S C and Son, Inc recalls Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray b
Hazard: Chemical Contamination