FDA Enforcement Recalls Linked to Manufacturing Facilities (100 Recent)
Live openFDA Food, Dietary Supplement, Drug, and Medical Device enforcement reports connected to canonical plant profiles.
Class II
H-0130-2027 · 2026-10-28
Dietary Supplements
El Ruisenor De Mexico, Inc. (CA)
Product: Jovy Gummy Worms Neon; packaged in 1lb plastic units. UPC 712199083411
Reason: undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6, Blue#1)
Class II
H-0158-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Milk Chocolate Covered Raisins; packaged in 1lb, 5lb, 20lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Milk, Soy)
Class III
H-0162-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Whole wheat flour; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Wheat)
Class I
H-0141-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Special Red Almond Mole Powder; packaged in 1lb, 5lb, 11lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Sesame, Peanuts, Wheat, Soy, Almonds, Walnuts, Yellow#5, Yellow#6, Red#40, Blue#2)
Class II
H-0120-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Fritura mixed dry fruit; packed in a clear plastic 1lb, 5lb, 25lb unit sizes. no UPC
Reason: undeclared allergen ingredient (Wheat, Yellow #5, Yellow #6)
Class III
H-0104-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Black Sesame Seeds; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC
Reason: undeclared allergen ingredient (Sesame)
Class III
H-0159-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: 10X10 Wheat Snack; packaged in 2lb, 5lb, 33lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Wheat)
Class III
H-0155-2027 · 2026-10-28
Dietary Supplements
El Ruisenor De Mexico, Inc. (CA)
Product: Textured Soy Protein; packaged in 1lb, 5lb, 33lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Soy)
Class II
H-0165-2027 · 2026-10-28
Food & Beverage
Voila Juice Company (CA)
Product: Voila! juice 100% SQUEEZED ORANGE VOILA! OAKLAND, CA 94601 16 OZ: UPC 701725001074 32 OZ: UPC 701725001081 64 OZ: UPC 701725001098 128 OZ: UPC 701725001104
Reason: Product not processed to achieve 5-log pathogen reduction.
Class II
H-0132-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: All-Purpose Flour; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Wheat)
Class I
H-0123-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Fritura Rueda Papa / Potato Wheel Snack; packed in a clear plastic 1lb, 5lb, 33lb unit sizes. No UPC
Reason: undeclared allergen ingredient (Wheat)
Class III
H-0119-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Soybeans; packed in a clear plastic 1lb, 5lb, 50lb unit sizes. No UPC
Reason: undeclared allergen ingredient (Soy)
Class I
H-0136-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Horchata Drink Mix; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Milk)
Class II
H-0117-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Churro Mix; packed in a clear plastic 1lb, 5lb, 50lb unit sizes. no UPC
Reason: undeclared allergen ingredient (Egg, Wheat)
Class II
H-0129-2027 · 2026-10-28
Dietary Supplements
El Ruisenor De Mexico, Inc. (CA)
Product: Jovy Gummy Bears Regular; packed in a clear plastic 1lb unit sizes. UPC: UPC 712199085156
Reason: undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6, Blue#1)
Class III
H-0106-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Almonds in Shell; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC
Reason: undeclared allergen ingredient (Almond)
Class III
H-0160-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: 4X6 Wheat Snack; packaged in 1lb, 5lb, 33lb clear plastic units. 4X8 Wheat Snack; packaged in 1lb, 5lb, 33lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Wheat)
Class II
H-0149-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Dried Pears; packaged in 1lb, 5lb, 25lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Sulfites)
Class III
H-0154-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Wheat Bran; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Wheat)
Class III
H-0112-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Butter Toffee Peanuts; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC
Reason: undeclared allergen ingredient (Peanuts, Milk)
Class II
H-0167-2027 · 2026-10-28
Food & Beverage
Pacific Coast Producers (CA)
Product: Great Value Fruit Cocktail in Fruit Juice from Concentrate NET WT 15 OZ (425g) DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 UPC: 078742369570
Reason: Potential contamination with elevated levels of lead.
Class I
H-0174-2027 · 2026-10-28
Food & Beverage
EAK Distribution LLC (WY)
Product: Heirloom Homegrown Green Sprouting Calabrese Broccoli Sprouts Seed. Net wt. 8oz ASIN #B09P49WHHP, UPC 8 50056 62744 3. EAK Distribution LLC 5830 E. 2nd St. PMB 91446 Casper, WY 82609 Label with Growing Instructions ***Easy to Grow ***Up to 24 Servings***90%+ Germination Rates***
Reason: Salmonella.
Class II
H-0150-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Dried Diced Pineapple; packaged in 1lb, 5lb, 44lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Sulfites)
Class II
H-0121-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Fritura Lagrimita / Teardrop Wheat Snack; packed in a clear plastic 1lb, 5lb, 44lb unit sizes.
Reason: undeclared allergen ingredient (Wheat, Yellow #6, Soy)
Class II
H-0164-2027 · 2026-10-28
Food & Beverage
Trader Joe's Company (CA)
Product: Trader Joe's Crispy Rice Milk Chocolate Bar; Imported from Belgium, 3- 1.75 oz bars. Package contains 3 individually wrapped bars packaged together within one outer label. UPC: 00515092
Reason: Undeclared wheat. Product outer label incorrect; contains wrong allergen ingredients.
Class III
H-0134-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Harina de Trigo; Whole Wheat Flour; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC
Reason: undeclared allergen ingredient (Wheat)
Class III
H-0133-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Almond Flour; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Almond)
Class II
H-0116-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Whole Pitted Dried Apricots; packed in a clear plastic 1lb, 5lb, 28lb unit sizes. no UPC
Reason: undeclared allergen ingredient (Sulfites)
Class I
H-0146-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Bread Crumbs; packaged in 1lb, 5lb, 50lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Milk, Wheat, Sesame, Soy)
Class II
H-0137-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Dried Kiwi Slices; packaged in 1lb, 5lb, 44lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Sulfites, Yellow#5, Blue#1)
Class II
H-0096-2027 · 2026-10-28
Food & Beverage
Gearharts Fine Chocolates, Inc. (VA)
Product: GEARHARTS FINE CHOCOLATES Net Wt. 4oz UPC 8 98111 00205 7; Net Wt. 8oz UPC 8 98111 00206; Gearharts Fine Chocolates 243B Ridge McIntire Rd, Charlottesville, VA 22902
Reason: Foreign Object - Broken glass was found in a piece of finished product.
Class III
H-0111-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Dried Cod; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC
Reason: undeclared allergen ingredient (Fish)
Class II
H-0170-2027 · 2026-10-28
Dietary Supplements
EVEXIAS HEALTH SOLUTION (TX)
Product: Evexias Health Solutions Amino Ultra, 90-capsules, dietary supplement in white plastic bottles with blue/green/white labeling
Reason: The product is mislabeled and fails to declare fish oil.
Class II
H-0124-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Dried Fruit Mix; packed in a clear plastic 1lb, 5lb, 25lb unit sizes.
Reason: undeclared allergen ingredient (Sulfites, Yellow#6)
Class II
H-0139-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Air-Dried Apple Rings; packaged in 1lb, 5lb, 22lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Sulfites)
Class III
H-0105-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Hulled Sesame Seeds; packed in a clear plastic bag. 1lb, 5lb, 50lb unit size. No UPC
Reason: undeclared allergen ingredient (Sesame)
Class II
H-0118-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Dried Peaches; packed in a clear plastic 1lb, 5lb, 22-25lb unit sizes. No UPC
Reason: undeclared allergen ingredient (Sulfites)
Class II
H-0125-2027 · 2026-10-28
Dietary Supplements
El Ruisenor De Mexico, Inc. (CA)
Product: Jovy Gummy Peach Rings; packed in a clear plastic 1lb unit sizes. UPC: 712199083404
Reason: undeclared allergen ingredient (Red#40, Yellow#5, Yellow#6)
Class II
H-0138-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Dried Mango Slices; packaged in 1lb, 5lb, 44lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Sulfites, Yellow#6)
Class III
H-0152-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Shelled White Pine Nuts; packaged in 1lb, 5lb, 25-55lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Pine Nuts)
Class II
H-0151-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Dried Pineapple Rings; packaged in 1lb, 5lb, 44lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Sulfites)
Class III
H-0153-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Raw Shelled Pistachios; packaged in 1lb, 5lb, 25-30lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Pistachios)
Class III
H-0144-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Walnut halves; packaged in 1lb, 5lb, 22-25lb clear plastic units. No UPC
Reason: undeclared allergen ingredient (Walnuts)
Class III
H-0108-2027 · 2026-10-28
Food & Beverage
El Ruisenor De Mexico, Inc. (CA)
Product: Roasted Whole Almonds; packed in a clear plastic bag. 1lb, 5lb, 25lb unit size. No UPC
Reason: undeclared allergen ingredient (Almond)
Class I
H-0173-2027 · 2026-10-28
Food & Beverage
Gardeners Basics (UT)
Product: Gardners Basics brand Waltham 29 Broccoli Sprouting Seeds packaged in a white and green resealable pouch, net weight 1 pound (454 g), with UPC: 848137042889. The bag is marked with Packed for 2027.
Reason: Salmonella
Class II
D-0062-2027 · 2026-10-28
Cosmetics & Skincare
PRITAM INTERNATIONAL PRIVATE LIMITED (US)
Product: Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-520-35, Item # 88520, UPC 8 10147 88520 6
Reason: CGMP Deviations.
Class I
D-0082-2027 · 2026-10-28
Pharmaceuticals & Sterile/OTC Drugs
Par Health USA, LLC (MI)
Product: Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10
Reason: Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Class II
D-0060-2027 · 2026-10-28
Pharmaceuticals & Sterile/OTC Drugs
PRITAM INTERNATIONAL PRIVATE LIMITED (US)
Product: evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.24%) Sweet Mint, Net Wt. 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-620-35, Item # 88620 UPC8 10147 88620 3
Reason: CGMP Deviations.
Class II
D-0056-2027 · 2026-10-28
Pharmaceuticals & Sterile/OTC Drugs
PRITAM INTERNATIONAL PRIVATE LIMITED (US)
Product: Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride0.243%) Watermelon Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-004-40, Item # Product code: 32730, UPC 8 50048 32730 6.
Reason: CGMP Deviations.
Class II
D-0067-2027 · 2026-10-28
Pharmaceuticals & Sterile/OTC Drugs
PRITAM INTERNATIONAL PRIVATE LIMITED (US)
Product: BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0,24%) Peppermint, Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-885-42, Item # 88542, UPC 8 10147 88542 8
Reason: CGMP Deviations.
Class II
D-0058-2027 · 2026-10-28
Pharmaceuticals & Sterile/OTC Drugs
PRITAM INTERNATIONAL PRIVATE LIMITED (US)
Product: Brush Buddies, My Little Pony Scents Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Bubble Gum Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-008-40, Item# 88270, UPC 8 10147 88270 0.
Reason: CGMP Deviations.
Class II
D-0066-2027 · 2026-10-28
Pharmaceuticals & Sterile/OTC Drugs
PRITAM INTERNATIONAL PRIVATE LIMITED (US)
Product: BB (Brush Buddies) Cavity Protection, Anti-Cavity Fluoride Toothpaste, (sodium monofluorophosphate 0.76%) Cool Mint, 2 Value Pack, Two 3.5 oz (99g) tubes, Total Net Wt 7 oz (198g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-035-10, Item # 88543, UPC
Reason: CGMP Deviations.
Class II
D-0079-2027 · 2026-10-28
Pharmaceuticals & Sterile/OTC Drugs
STRIDES PHARMA INC (NJ)
Product: Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured by: Strides Pharma Science Ltd. Puducherry, 605 014, India; Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807, NDC 64380-883-04
Reason: Failed dissolution specifications
Class II
D-0054-2027 · 2026-10-28
Pharmaceuticals & Sterile/OTC Drugs
PRITAM INTERNATIONAL PRIVATE LIMITED (US)
Product: Brush Buddies, Hot Wheels, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-002-40, Item # 88047, UPC 8 10147 88047 8
Reason: CGMP Deviations.
Class II
D-0076-2027 · 2026-10-28
Pharmaceuticals & Sterile/OTC Drugs
Hikma Pharmaceuticals USA INC. (OH)
Product: Abirtega (abiraterone acetate) USP, 250 mg, 120-count bottles, Rx only, Rx only, Mfd for: Hikma Pharmaceuticals USA Inc., Berkley Heights, NJ 07922 USA by: Arab Pharmaceuticals Manufacturing PSC PO Box 41, Sahab-Jordon, NDC 82249-011-12.
Reason: Failed Tablet/Capsule Specifications: Failed tablet specifications for weight uniformity.
Class II
D-0050-2027 · 2026-10-28
EPA / Specialty Chemical
Shenzhen Techdow Pharmaceutical Co., Ltd. (US)
Product: Heparin Sodium Injection, USP, 5,000 USP Units/mL, 1mL Multi dose vial x 25 vials per carton, Distributed by: Hepalink USA Inc., Langhome, PA 19047-1885. Carton NDC: NDC 81952-111-06, Vial NDC: 81942-111-01
Reason: Lack of Assurance of Sterility
Class II
D-0057-2027 · 2026-10-28
Pharmaceuticals & Sterile/OTC Drugs
PRITAM INTERNATIONAL PRIVATE LIMITED (US)
Product: Brush Buddies, Crayola Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride 0.243%) Strawberry Flavor, Net Wt. 4.0 oz (113g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-005-40, Item # 32732, UPC 8 50048 32732 0
Reason: CGMP Deviations.
Class II
D-0068-2027 · 2026-10-28
Pharmaceuticals & Sterile/OTC Drugs
PRITAM INTERNATIONAL PRIVATE LIMITED (US)
Product: ARU, Toothpaste, Gum Health, 9 Ingredients, Soothing Mint, (stannous fluoride 0.45%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-786-35, Item # 88786 UPC 8 10147 88786 6
Reason: CGMP Deviations.
Class III
D-0049-2027 · 2026-10-28
Pharmaceuticals & Sterile/OTC Drugs
Viatris, Inc. (WV)
Product: Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India, NDC 0378-1075-93.
Reason: Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications
Class I
D-0084-2027 · 2026-10-28
Pharmaceuticals & Sterile/OTC Drugs
Greenwich Rx (TX)
Product: Glutathione Injection (Glutathione-L, Ascorbic Acid, Sodium Hydroxide, Bacteriostatic Water), 200 mg/mL, 10 mL multi-dose vial, Rx only, Subcutaneous Only, Greenwich Rx.
Reason: Microbial Contamination of Sterile Products