FDA Recalls in 2025
2,242 recalls found
December 2025
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.
cGMP deviations
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96
Failed Stability Specifications: Observed OOS results: eg results for colour index
Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.
cGMP deviations
Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.
cGMP deviations
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.
cGMP deviations
Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.
cGMP deviations
Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.
cGMP deviations
WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.
cGMP deviations
Lotsa Pasta International Food Shop Fresh Basil Infused Olive Oil, Net Wt. 12 oz. (375ml), packaged in a glass bottle, UPC 736211448316, packed 12 bottles per case
Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed.
Happy Farms by Aldi Italian Style shredded cheese blend (containing low-moisture part-skim mozzarella, not-smoked provolone, romano, asiago & parmesan finely shredded cheeses), 12 oz., individually packaged in a plastic bag, UPC 4061463330949, 6/combo case also containing 6 bags of Taco Style product
Potential metal fragments from supplier raw material (downstream recall)
Loaded Veggie Grain Bowl; NET WT. 10/90 OZ (309g) NO UPC Identifying N4L code: V3FR
Potential contamination with Listeria monocytogenes.
Low-moisture part-skim mozzarella shredded cheese, individually packaged in a plastic bag, as: 1) Always Save - Shredded, 5 lb., UPC 7003865782, 4/case 2) Borden - Shredded, 8 oz., UPC 5300007162, 6 or 12/case - Thick Cut, 8 oz., UPC 5300007170, 6/case 3) Brookshire's - Finely Shredded, 8 oz., UPC 9282510119, 12/case - Shredded, 8 oz., UPC 9282510120, 12/case - Shredded, 32 oz., UPC 9282510130, 6/case - Thick Cut, 8 oz., UPC 9282592197, 12/case 4) Cache Valley Creamery - Shredded, 8 oz., UP
Potential metal fragments from supplier raw material (downstream recall)
Blonde Beard's Dojo Asian Wing Sauce, wing sauce hot sauce condiment, shelf stable, 2 years, glass bottle, 8 oz, Blonde Beard s. Responsible firm on label: Blonde Beard s 2230 S Braun Ct Lakewood, CO 80228.
Undeclared Soy
Genepro Whey 4th Generation Plasma Treated Protein, unflavored, Net Wt. 225g, 30 servings, packaged in a resealable mylar bag, UPC 850053365126, Manufactured For: Genepro Protein, Inc. 15000 Weston Parkway, Cary NC 27513 Front label reads, in part: "* LACTOSE FREE * DAIRY FREE *ALLERGEN FREE" Back label reads, in part: "OTHER INGREDIENTS: Hydrolyzed NiHPRO ProteinIsolate (Pea Protein Isolate, Rice Protein Isolate, Mungbean Protein Isolate, L-Lysine, L-Leucine, L-Threonine, L-Methionine). CONT
Product is mislabeled - the labeling contains incorrect ingredient information and fails to declare milk as an allergen
Pacific Seafood Raw Blackened Shrimp Peeled & Deveined Tail-Off, refrigerated, farm-raised. Net wt. per tray 8 oz (227 g). UPC 0 27241 44630 5. Ingredients: Shrimp (Shrimp, Water, Salt, Sodium tripolyphosphate (to retain moisture), Blackened Seasoning (Sea Salt, Paprika, Spices, Onion, Garlic, Paprika Extract). CONTAINS: Shrimp (Crustacean Shellfish). Product of Ecuador. Packed and distributed by Pacific Seafood Group Clackamas, OR.
Undeclared Sulfite. Shrimp may contain 3.4mg Sulfur Dioxide per serving and label does not declare Sulfite.
Publix Deli Carolina-Style Mustard BBQ Sauce; 96- 2OZ NET WT: 12 LB SKU: 10 026700 16964 6
foreign objects (black plastic planting material) in granulated onion
Costco Item# 11444 Kirkland Signature Chicken Sandwich with Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The net weight varies as it is sold by weight. This product contains 3oz. sealed packet of Caesar Dressing.
The 3oz. sealed packet of Caesar Dressing in Costco Chicken Sandwich w/ Caesar Salad may contain plastic material.
Mozzarella and provolone shredded cheese blend (containing low-moisture part-skim mozzarella and not-smoked provolone cheeses), individually packaged in a plastic bag, as: 1) Freedom's Choice Pizza Blend - Fine-Cut, 32 oz., UPC 4279810410, 6/case 2) Good & Gather Mozzarella & Provolone - Classic, 8 oz., UPC 8523903871, 12/case 3) Great Lakes Cheese Mozzarella & Provolone - Shredded, 5 lb., UPC 3651415115, 4/case 4) Great Value Provolone & Mozzarella Blend - Shredded, 16 oz., UPC 7874226743,
Potential metal fragments from supplier raw material (downstream recall)
Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement 30 Tablets Rx Only UPC 3 75854 30630 2 Manufactured for: Avion Pharmaceuticals, LLC Alpharetta, GA 30005
Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.
Aojia Dried Red Bayberry; packaged in 5.6oz (160g) clear plastic bottle; UPC 6942514920327
Product contains undeclared sulfites (7.39mg/serving) and cyclamates
Retail Box: Haagen-Dazs mini chocolate dark chocolate ice cream bars 6 BARS/11.1 FL/OZ(328mL) INGREDIENTS: CHOCOLATE ICE CREAM: CREAM, SKIM MILK, SUGAR, COCOA PROCESSED WITH ALKALI, EGG YOLKS. DARK CHOCOLATE AND VEGETABLE OIL COATING: DARK CHOCOLATE (SUGAR, CHOCOLATE, SOY LECITHIN, VANILLA EXTRACT), COCONUT OIL, SOYBEAN OIL. CONTAINS: MILK, EGG AND SOY INGREDIENTS. MAY CONTAIN TREE NUTS. DISTRIBUTED BY: DREYER'S GRAND ICE CREAM, INC., WALNUT CREEK, CA, 94596 UPC 0 74570 30605 3 Primary Packagin
Undeclared wheat.
My Bladder; Supports normal bladder tone & control; Dietary Supplement; packaged in white HDPE bottle with a white cap; bottle size is 150 CC; the net contents in 60 clear capsules containing brown powder
Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303
Italian Salad Dressing; Net 1 GAL (3.78L) SKU: 7 67367 00518 4 Creamy Poblano Avocado Ranch Dressing and Dip; Net Contents 1 GAL93.78L) SKU: 7 34730 53243 1 Ventura Caesar Dressing; Net WT 2000LB (907.1kg) SKU: 00 026700 17360 8 Pepper Mill Regal Caesar Dressing; 1 GAL (128 FL OZ) 3.79 L SKU: 0 93901 72607 0 Pepper Mill Creamy Caesar Dressing; 1 GAL (128 FL OZ) 3.79 L SKU: 0 93901 78134 5 Ceasar Dressing (Costco Service Deli) NET WT: 23.62 LB (10.71 kg) SKU: 0 26700 19376 7 Ceasar Dressing (Cos
foreign objects (black plastic planting material) in granulated onion
Dry Roasted Baking Macadamia Nuts, Unsalted Halves Ideal for Baking, Cooking, Salads or Ice Cream; NET WT 20 OZ (1 LB 4 OZ) 567g UPC: 8 60011 44301 8
Potential Salmonella contamination.
COKE FARM Beans, Green 25 lb. Product of USA Coke Farm San Juan Bautista, CA 95045
Potential chemical contamination.
Lava Bun with Salted Egg Yolk orange packaging (Frozen) Unsalted butter and cream are listed in the ingredient statement.
Products do not declare milk in the Contains statement or the ingredient statement.
Onion granules (irradiated) ; 55 lbs carton Item# 5358
foreign objects (black plastic planting film) in granulated onion powder
Good & Gather Mozzarella & Parmesan shredded cheese blend, Fine Cut, 8 oz., individually packaged in a plastic bag, UPC 8523903856, 12/case
Potential metal fragments from supplier raw material (downstream recall)
Lava Bun with Green Tea Flavor bright lime green packaging (Frozen) Unsalted butter and cream are listed in the ingredient statement.
Products do not declare milk in the Contains statement or the ingredient statement.
Lotsa Pasta International Food Shop Roasted Garlic Infused Olive Oil, Net Wt. 12 oz. (375ml), packaged in a glass bottle, UPC 736211448415, packed 12 bottles per case
Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed.
Meadow Gold Hawaii's Dairy Fat Free Chocolate Milk, Grade A Pasteurized Homogenized Vitamin A&D, half-pint carton. Product is perishable keep refrigerated. UPC 8 50019 06410 0. Ingredients: Nonfat Milk, Sugar Cane, Cocoa (processed with Alkali), Corn Starch, Carrageenan, Salt, Natural Flavor, Vitamin A Palmitate, Vitamin D3. Distributed By: Meadow Gold Dairies, Hilo, HI. Plant #06-2374
Half-pint chocolate fat free milk is recalled due to potential quality control issues.
Italian style shredded cheese blend (containing low-moisture part-skim mozzarella, provolone, parmesan, romano, fontina and asiago cheese), individually packaged in a plastic bag, as: 1) Brookshire's Italian 6-Cheese - Finely Shredded, 8 oz., UPC 9282510174, 12/case 2) Cache Valley Creamery Six Cheese Italian - Finely Shredded, 8 oz., UPC 7495800257, 12/case 3) Coburn Farms Italian Style - Finely Shredded, 12 oz., UPC 5193365638, 18/case 4) Great Value Italian Style - Finely Shredded, 8 oz.,
Potential metal fragments from supplier raw material (downstream recall)
Organic Moringa Leaf Powder (Moringa Powder) , 4 oz. and 1 Kilogram, 4 oz size in a solid plastic container / 1 kg size in a plastic bag in a box. Distributed by: Africa Imports, South Hackensack, NJ 07606
Product tested positive for Salmonella.
Sonex brand aluminum pot; ISO 9001:2000; Made in Pakistan
Products found to contain leachable lead levels (0.323mg/L)
Pizza style shredded cheese blend (containing low-moisture part-skim mozzarella and mild cheddar cheeses), individually packaged in a plastic bag as: 1) Econo Pizza - Shredded, 8 oz., UPC 893800297, 12/case 2) Food Club Pizza Style Two Cheese Blend - Finely Shredded, 8 oz., UPC 3680012422, 12/case - Shredded, 32 oz., square-style bag, UPC 3680044487, 6/case - Shredded, 32 oz., tube-style bag, UPC 3680048197, 6/case 3) Gold Rush Creamery Pizza Blend - Shredded, 32 oz., UPC 1401401030, 6/cas
Potential metal fragments from supplier raw material (downstream recall)
Costco Item# 19927 Kirkland Signature Caesar Salad, refrigerated, packaged in clear plastic clamshell container. The net weight varies as it is sold by weight. This product contains 3oz. sealed packet of Caesar Dressing.
The 3oz. sealed packet of Caesar Dressing in Costco Caesar Salad may contain plastic material.
Food Club Finely Shredded Pizza Style Four Cheese Blend (containing low-moisture part-skim mozzarella, not-smoked provolone, parmesan & romano cheeses), 8 oz., packaged individually in a plastic bag, UPC 3680017231, 12/case
Potential metal fragments from supplier raw material (downstream recall)
VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay)
Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
bioMerieux notified customers on about 03/01/2018, via letter. Instructions included to distribute the recall information to all appropriate personnel in the laboratory, forward the information to individuals to which the product many have been transferred to, destroy any impacted lots on site, and complete and return the Acknowledgement Form. Questions and concerns can be directed to local bioMerieux Customer Service representatives or for Clinical Technical Support Center by email at CustomerService-ImmunoMolecular@biomerieux.com.
Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5
CGMP Deviations
Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8
CGMP Deviations
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6
CGMP Deviations
Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05
CGMP Deviations
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).
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05
CGMP Deviations
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02
CGMP Deviations
Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02
CGMP Deviations
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
CGMP Deviations
Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02
CGMP Deviations
Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02
CGMP Deviations
Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0
CGMP Deviations