FDA Recalls in 2025
2,242 recalls found
October 2025
Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7 oz (201 g), Monika Kiripolsky, MD Beverly Hills, CA, 90211
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com
Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was discovered during post consume awareness with benzoyl peroxide products.
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, Extended-Release Capsules, (Mixed Salts of a Single Entity Amphetamine Product), 30 mg, 100 Capsules, Rx only, Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-034-01
Failed Impurities/Degradation Specifications:
Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.
cGMP Deviations
Blue Razz 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD and 20mg D9 THC per gummy Dosage: Not declared at bulk stage (consignee determines serving size) Form: Gummy Administration: Oral Intended use: Dietary supplement for further packaging/labeling by consignee Type of packaging: Shipped in poly gusset bags, inside corrugated brown boxes, no consumer label applied. Net wt. Blue Razz: 24 bags x 5kg and 1 bag x 4kg
Potential peanut protein cross-contact.
Middlefield Original Cheese Co-op Shredded Mozzarella Cheese, 5 lb., shredded in a plastic bag and packed 4 bags per case
Potential contamination with Listeria monocytogenes
Middlefield Original Cheese Co-op Smoked Cheddar, 5 lb. loaves, packaged 8 loaves per case
Potential contamination with Listeria monocytogenes
GOODLES HERE COMES TRUFFLE CREAMY TRUFFLE FLAVORED CHEDDAR AND SHELLS NET WT 6 OZ (170g) INGREDIENTS: GOODLES SHELLS (WHEAT FLOUR, CHICKPEA PROTEIN, WHEAT PROTEIN, NUTRIENTS EXTRACTED FROM [BROCCOLI, SPINACH, KALE, PUMPKIN, SWEET POTATO, SUNFLOWER SEED, CRANBERRY, CHLORELLA, MAITAKE MUSHROOM, SHIITAKE MUSHROOM]), CHEDDAR AND PARMESAN CHEESES (CULTURED MILK, SALT, DISODIUM PHOSPHATE, ENZYMES), WHEY, NATURAL FLAVOR, BUTTER (CREAM, SALT), NONFAT DRY MILK, SALT, TAPIOCA FLOUR, NUTRITIONAL YEAST, LAC
Undeclared allergens (cashews).
1) Middlefield Original Cheese Co-op All Natural Pepper Jack Cheese, packaged as 5 lb. loaves wrapped in plastic and packed 2 loaves per case (distribution) or 8 loaves per case (retail), or sliced and packaged as 2 lb. deli bags and packed 5 bags per case 2) Middlefield Original Cheese Co-op Pepper Jack, 5 lb., shredded and packaged in a plastic bag, packed 4 bags per case
Potential contamination with Listeria monocytogenes
GOODLES VEGAN IS BELIEVIN' PLANT-BASED WHITE CHEDDAR WITH SPIRALS NET WT 5.25 OZ (149g) INGREDIENTS: GOODLES SPIRALS (WHEAT FLOUR, CHICKPEA PROTEIN, WHEAT PROTEIN, NUTRIENTS EXTRACTED FROM [BROCCOLI, SPINACH, KALE, PUMPKIN, SWEET POTATO, SUNFLOWER SEED, CRANBERRY, CHLORELLA, MAITAKE MUSHROOM, SHIITAKE MUSHROOM]), VEGAN WHITE CHEDDAR CHEESE (DRIED CASHEW MILK [CASHEWS, CHICORY ROOT FIBER], NATURAL FLAVOR, NUTRITIONAL YEAST, TAPIOCA FLOUR, PEA PROTEIN, LACTIC ACID, DRIED APPLE CIDER VINEGAR, GARLI
Undeclared allergens (milk).
PURE CANE GRANULATED SUGAR, NET WT 50 LB (22.67kg), Distributed by Domino Foods, Inc., Yonkers, NY 10705, STORE IN A COOL, DRY PLACE
Potential contamination with foreign objects.
Sugar-free Mixed Berry Gummies Brand Name: Extract Labs Generic Name: Dietary Supplement Strength: 10mg CBD and 10mg D9 THC per gummy Dosage: 1 gummy Form: Gummy Administration: Oral Intended use: Dietary Supplement Type of packaging: 225cc amber packer bottle with child-resistant cap and inner pressure seal Net wt: 3.53oz UPC: 850029647928 Firm name & address: Extract Labs, Inc., 1399 Horizon Ave, Lafayette, CO 80026
Potential peanut protein cross-contact.
Middlefield Original Cheese Co-op Shredded Mozzarella/Provolone Cheese, 5 lbs., packaged in a plastic bag, packed 4 bags per case
Potential contamination with Listeria monocytogenes
Middlefield Original Cheese Co-op Original Swiss Cheese, packaged as 5 lb. loaves wrapped in plastic and packed 2 loaves per case (distribution) or 8 loaves per case (retail), or sliced and packaged as 2 lb. deli bags and packed 5 bags per case
Potential contamination with Listeria monocytogenes
Elderberry 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD and 20mg D9 THC per gummy Dosage: Not declared at bulk stage (consignee determines serving size) Form: Gummy Administration: Oral Intended use: Dietary supplement for further packaging/labeling by consignee Type of packaging: Shipped in poly gusset bags, inside corrugated brown boxes, no consumer label applied. Net wt. Elderberry: 24 bags x 5kg and 1 bag x 3.
Potential peanut protein cross-contact.
Middlefield Original Cheese Co-op Organic Gouda Cheese, 8 oz., packaged individually in plastic, packed 12 per case
Potential contamination with Listeria monocytogenes
1) Sunrise Creamery Dilly Pickle Monterey Jack Cheese with Dill Pickles, Net Wt. 6 oz., packaged individually in plastic, packed 12 per case, UPC: 810665011156 2) Sunrise Creamery Dilly Pickle Jack Monterey Jack Cheese with Dill Pickles, Net Wt. 1.25 LBS (567 g), packaged individually in plastic, packed 12 per case, UPC: 810665011484
Potential contamination with Listeria monocytogenes
1) Middlefield Original Cheese Co-op All Natural Mild Cheddar Cheese, 5 lb., packaged as individual loaves wrapped in plastic, packed 2 loaves per case (distribution) or 8 loaves per case (retail) 2) Middlefield Original Cheese Co-op Shredded Cheddar Cheese, 5 lb., packaged in a plastic bag, packed 4 bags per case
Potential contamination with Listeria monocytogenes
UDK ,Half Plum, 170 g, Container, 24, ambient
Cyclamate adulteration
MMBAL pasteurized donor human milk (PDHM), 100 mL (3.38 fl. oz.), packaged in a BPA-free plastic bottle
Potential physical contaminant
Mai Tai 20mg Gummies Brand Name: None - unlabeled bulk (private-label consignee) Generic Name: Dietary Supplement Strength: 20mg CBD and 20mg D9 THC per gummy Dosage: Not declared at bulk stage (consignee determines serving size) Form: Gummy Administration: Oral Intended use: Dietary supplement for further packaging/labeling by consignee Type of packaging: Shipped in poly gusset bags, inside corrugated brown boxes, no consumer label applied. Net wt. Mai Tai: 24 bags x 5kg and 1 bag x 4kg UPC:
Potential peanut protein cross-contact.
1) Middlefield Original Cheese Co-op Monterey Jack, 5 lb., packaged as loaves wrapped in plastic and packed 8 loaves per case 2) Middlefield Original Cheese Co-op Provolone, 5 lb., packaged as loaves wrapped in plastic and packed 2 loaves per case
Potential contamination with Listeria monocytogenes
September 2025
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Product is mislabeled for size.
A customer letter was issued to affected consignees dated 11/09/2021. Consignees are asked to move all inventory to quarantine and returned all impacted product within 10 days of letter receipt. If the product was further distributed, the consignee is directed to notify downstream customers of the recall. An Acknowledgement and Receipt Form should be completed indicating the quantity that will be returned. This should be completed even if there is no inventory.
bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226
Lack of Assurance of Sterility
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Failed Impurity/Degradation Specifications
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11)
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03
Superpotent drug
Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821, NDC 45567-0655-1
Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, Manufactured by: Unichem Laboratories, Ltd, Pilerne Ind. Estate, Pilerne, Bardez, Goa, India; Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ. NDC 29300-415-19.
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Failed Impurity/Degradation Specifications
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10.
cGMP deviations: Temperature excursion during transportation.
CHARGE-UP CHILAQUILES Traditional Mexican breakfast consisting of tortilla chips smothered in a spicy tomatillo salsa and beans, topped with egg and cheese. NET WT 3.5 OZ (100G) INGREDIENTS: *** VEGETABLE FLAVOR BASE (SALT, SUGAR, SOYBEAN OIL, ONION POWDER, CORN STARCH, MALTODEXTRIN, HYDROLYZED CORN PROTEIN, GARLIC POWDER, TURMERIC (COLOR), SPICES, CARROT JUICE CONCENTRATE, CALCIUM SILICATE (ANTICAKING AGENT), CARAMEL COLOR, NATURAL FLAVORS, DISODIUM INOSINATE, DISODIUM GUANYLATE, CITRIC ACID) *
Undeclared Yellow #5 and Yellow #6.
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
PRIMENUTRITION TAURINE MENTAL & ATHLETIC PERFORMANCE 125 SERVINGS SUPPORTS ENERGY PRODUCTION PROTEN ANTIOXIDANT PROPERTIES SUPPORTS HEALTHY BLOOD SUGAR LEVELS NET WT. 8.12OZ (250g) DIETARY SUPPLEMENT UPC 6 89466 70601 7 Manufactured by: Prime Nutrition 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
(Bulk) Oyster, Frozen, Raw Half Shell, 15lb(6.8kg) UPC: 10087703078342 Harvest Dates: Jan 03,2025, Jan 14,2025
Oyster product potentially contaminated with Norovirus
Frozen AquaStar Breaded Shrimp, Butterfly, Clean-Tail, 16/20 count/lb. 3 lbs. package. Net wt. per case 36lbs. (12x3lbs. packages per case). UPC 731149601192. Packed For: AquaStar Seattle, WA. Farm Raised Product of Indonesia.
Product may be contaminated with Cesium-137 (Cs-137).
HI-TECH PHARMACEUTICALS BETA SITOSTEROL (715MG PINE DERIVED PHYTOSTEROL 99%) PROVIDES SUPPORT FOR OVERALL CARDIOVASCULAR HEALTH HELPS MAINTAIN HEALTHY CHOLESTEROL LEVELS ALREADY WITHIN THE NORMAL RANGE SUPPORTS PROSTATE AND IMMUNE HEALTH 90 TABLETS UPC 8 11836 02587 3 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims and Misbranded.
Tuscan Artichoke and Mozzarella Salad; Keep Refrigerated, NET WT: 8.5 OZ, UPC# 6 82906 90935 1 Manufactured by Fresh and Ready Foods LLC, San Fernando, CA 91340
undeclared allergen (Wheat and Milk) on ready to eat sandwiches.
Endico brand MIXED VEGETABLES; NET WT. 2.5 lbs (40 oz.) (1134 g); KEEP FROZEN UNTIL READY TO USE; Dist. by Endico Potatoes Inc; PRODUCT OF EGYPT; To prepare: Place contents in boiling water. Cook until tender. Season to taste and serve.; Cook to 165 F For Quality And Food Safety; INGREDIENTS: Carrots, Beans, Peas, Corn
Product may be contaminated with Listeria monocytogenes.
Best Yet; Arctic Shores; and Great American branded Frozen cooked shrimp; 1 Pound/ 12 OZ/ 6 OZ/ 2 Pound plastic bag; (Various Brands) UPC#: 042187002736; 042187002743; 041130812392; 041130810497; 041130810411; 041130811685; 829944092540; 829944012173
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
HI-TECH PHARMACEUTICALS FISH OIL HEART AND BRAIN HEALTH EPA/DHA OMEGA 3 FATTY ACIDS SUPPORTS CARDIOVASCULAR HEALTH MAY HELP WITH JOINT PAIN MAY IMPROVE COGNITIVE FUNCTION 90 SOFT GELS UPC 8 11836 02585 9 HI-TECH PHARMACEUTICALS, INC. 6015-B Unity Drive Norcross, GA 30071
Unapproved Drug Claims.
Cucumbers Peeled/Dice 1/4" KBS 5LB, Cardboard boxes
Product contaminated with Salmonella
Frozen Mercado Kroger Cooked Shrimp - Medium - Peeled - Tail-Off - Shrimp Pieces. 2 lbs. package. Net wt. per case 10lbs. (5x2lb packages per case). UPC 011110626196.
Product may be contaminated with Cesium-137 (Cs-137).
AquaStar Cocktail Shrimp, 4oz. shrimp/2oz. cocktail sauce. Each case consists of 6x6 oz packages, UPC 19434612191. Distributed by Aqua Star, Seattle, WA. Farm Raised Product of Indonesia. Master cases distributed to distributors in frozen condition. AquaStar Cocktail Shrimp, 4oz. shrimp/2oz. cocktail sauce, net wt. 6oz. UPC 19434612191. Distributed by Aqua Star, Seattle, WA. Farm Raised Product of Indonesia. 6oz packages sold to consumers at Walmart as refrigerated product.
Product may be contaminated with Cesium-137 (Cs-137).
Sea Salt Caramel Dark Miniature, Item ID: 2237 ML. Packed On (YYMMDD): 25-07-22. 5.20 lb. Box. Abdallah Candies
Undeclared allergen (peanut, pecan).