Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 3 of 87
Somerset Therapeutics Private Limited
Class II Ongoing
Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (in...
Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination
D-0357-2025 April 16, 2025 Bengaluru, N/A
Ascent Consumer Products Inc.
Class I Ongoing
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net ...
Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
D-0299-2025 April 2, 2025 Melville, NY
Ascent Consumer Products Inc.
Class I Ongoing
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ...
Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
D-0301-2025 April 2, 2025 Melville, NY
Ascent Consumer Products Inc.
Class I Ongoing
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distri...
Reason: Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
D-0300-2025 April 2, 2025 Melville, NY
Fruit Of The Earth, Inc.
Class II Ongoing
Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015
Reason: Chemical contamination: presence of benzene
D-0283-2025 March 26, 2025 Grand Prairie, TX
Fruit Of The Earth, Inc.
Class II Ongoing
CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
Reason: Chemical contamination: presence of benzene
D-0284-2025 March 26, 2025 Grand Prairie, TX
Johnson, S C and Son, Inc
Class II Ongoing
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813...
Reason: Chemical Contamination
D-0276-2025 March 19, 2025 Racine, WI
Johnson, S C and Son, Inc
Class II Ongoing
Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; ...
Reason: Chemical Contamination
D-0275-2025 March 19, 2025 Racine, WI
Denison Pharmaceuticals, LLC
Class II Ongoing
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1
Reason: Chemical Contamination: Presence of benzene.
D-0273-2025 March 19, 2025 Lincoln, RI
Sigan Industries Group Inc.
Class II Ongoing
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8
Reason: Chemical Contamination: Presence of benzene
D-0274-2025 March 19, 2025 Brampton
CareFusion 213, LLC
Class I Ongoing
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Appl...
Reason: Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
D-0259-2025 March 19, 2025 El Paso, TX
Bionpharma Inc.
Class I Terminated
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
Reason: Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
D-0012-2025 October 23, 2024 Princeton, NJ
Vivier Pharma, Inc.
Class II Ongoing
Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mfd. for Vivier Pharma, Vaudereull-Dorion OC Canada, J7V 5V5, Cha...
Reason: Microbial Contamination of Non-Sterile Product
D-0662-2024 October 2, 2024 Vaudreuil-Dorion
PREQUEL SKIN
Class II Ongoing
BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4
Reason: Microbial contamination of non-sterile Products -
D-0657-2024 September 18, 2024 W Hollywood, CA
Baxter Healthcare Corporation
Class I Ongoing
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
D-0649-2024 September 11, 2024 Round Lake, IL
Homeocare Laboratories, Inc.
Class II Terminated
STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-143-16
Reason: Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism
D-0610-2024 July 24, 2024 Yonkers, NY
Brands International Corporation
Class II Ongoing
Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (236mL), packaged in an HDPE bottle 12 bottles per case, Manufactured By:/Fabrique Par: , Brands International Corp., Newmarket, ON, ...
Reason: Microbial Contamination of Non-Sterile Products: confirmed presence of mold contamination
D-0598-2024 July 24, 2024 Newmarket
Homeocare Laboratories, Inc.
Class I Terminated
STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01
Reason: Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms
D-0609-2024 July 24, 2024 Yonkers, NY
Zydus Pharmaceuticals (USA) Inc
Class III Completed
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-0...
Reason: Cross contamination with other products
D-0596-2024 July 17, 2024 Pennington, NJ
Zydus Pharmaceuticals (USA) Inc
Class III Ongoing
Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per cart...
Reason: Cross contamination with other products.
D-0592-2024 July 17, 2024 Pennington, NJ
SYNCHRONICITY SPA INC, DBA SUNTE
Class I Ongoing
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
Reason: Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
D-0588-2024 July 17, 2024 Las Vegas, NV
Zydus Pharmaceuticals (USA) Inc
Class III Completed
Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534...
Reason: Cross contamination with other products
D-0595-2024 July 17, 2024 Pennington, NJ
Zydus Pharmaceuticals (USA) Inc
Class III Ongoing
Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceut...
Reason: Cross contamination with other products.
D-0593-2024 July 17, 2024 Pennington, NJ
Pharma Nobis LLC
Class II Ongoing
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free, Sugar Free Grape, 10 fl. oz bottle, Distributed by: Meijer Distribution Inc., Grand Rapids,MI 49544, NDC 79481-0034-9
Reason: Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
D-0501-2024 May 22, 2024 Texarkana, TX
Pharma Nobis LLC
Class II Ongoing
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.
Reason: Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
D-0500-2024 May 22, 2024 Texarkana, TX