Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
D-0535-2026May 27, 2026Camarillo, CA
Wisconsin Pharmacal Company
Class IOngoing
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.
Reason: Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
D-0553-2026May 27, 2026Jackson, WI
Amerisource Health Services LLC
Class IIIOngoing
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose...
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
D-0536-2026May 27, 2026Columbus, OH
CareFusion 213, LLC
Class IIOngoing
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912...
Reason: Lack of assurance of Sterility: potential product contamination
D-0518-2026May 13, 2026El Paso, TX
CareFusion 213, LLC
Class IIOngoing
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42...
Reason: Lack of assurance of Sterility: potential product contamination
D-0517-2026May 13, 2026El Paso, TX
Acella Pharmaceuticals, LLC
Class IIOngoing
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
Reason: Chemical contamination; presence of lead and lithium above specification
D-0523-2026May 13, 2026Alpharetta, GA
Owen Biosciences Inc.
Class IIOngoing
HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) 2 FL OZ/60ml spray bottle; DIST BY HYDROPEPTIDE LLC, ISSAQUAH, WA 98027
Reason: Chemical contamination: Presence of benzene
D-0453-2026April 22, 2026Baton Rouge, LA
Owen Biosciences Inc.
Class IIOngoing
FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE ACNE TREATMENT, OTC a) 0.5 fl. oz./15ml; and b)1 fl. oz./30ml tubes; Made in the USA for FarmHouse Fresh, 8797 CR 858 McKinn...
Reason: Chemical contamination: Presence of benzene
D-0452-2026April 22, 2026Baton Rouge, LA
Owen Biosciences Inc.
Class IIOngoing
SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles, Sandra Lee MD, Distributed by Skin PS Brands, Culver City, CA90232.
Reason: Chemical contamination: Presence of benzene
D-0454-2026April 22, 2026Baton Rouge, LA
Owen Biosciences Inc.
Class IIOngoing
SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.
Reason: Chemical contamination: Presence of benzene
D-0455-2026April 22, 2026Baton Rouge, LA
Cardinal Health 200, LLC
Class IOngoing
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
Reason: Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
D-0528-2026March 25, 2026Waukegan, IL
Advanced Pharmaceutical Technology, Inc.
Class IIOngoing
TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
Reason: Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
D-0258-2026January 21, 2026Elmsford, NY
Medinatura New Mexico, inc.
Class IOngoing
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887
Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
D-0289-2026January 14, 2026Albuquerque, NM
Medinatura New Mexico, inc.
Class IOngoing
ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863
Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
D-0288-2026January 14, 2026Albuquerque, NM
Glenmark Pharmaceuticals Inc., USA
Class IIIOngoing
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy,...
Reason: Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
D-0199-2026December 10, 2025Elmwood Park, NJ
Medical Products Laboratories, Inc.
Class IIOngoing
Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01
Reason: Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
D-0179-2026December 3, 2025Philadelphia, PA
Fresenius Kabi USA, LLC
Class IOngoing
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
D-0182-2026December 3, 2025Lake Zurich, IL
GenoGenix LLC
Class IOngoing
NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 mg/mL, 10 mL multi-dose amber vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Microbial Contamination of Sterile Products: elevated endotoxin levels
D-0094-2026October 15, 2025Boca Raton, FL
Private Label Skin Care Inc.
Class IIOngoing
edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.
Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
D-0665-2025October 1, 2025Canoga Park, CA
Private Label Skin Care Inc.
Class IIOngoing
Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211
Reason: Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.