FDA · food & medication · last 6 months

The recall log.

Every food and medication enforcement action the FDA has published in the last six months. No account needed — this is public record, made readable.

914 ENFORCEMENT ACTIONS · CLASS I MEANS A REASONABLE PROBABILITY OF SERIOUS HARM

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Apple Cinnamon Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Apple Cinnamon Cream Cheese; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0555-2026 · 557-5lb tubs (Total)

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Caramel Apple Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Caramel Apple Cream Cheese; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0556-2026 · 557-5lb tubs (Total)

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Blueberry Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Blueberry Cream Cheese; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0557-2026 · 557-5lb tubs (Total)

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Garlic & Herb Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Garlic & Herb Cream Cheese; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0558-2026 · 557-5lb tubs (Total)

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Jalapeno Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Jalapeno Cream Cheese; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0559-2026 · 557-5lb tubs (Total)

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Jalapeno Cheddar Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Jalapeno Cheddar Cream Cheese; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0560-2026 · 557-5lb tubs (Total)

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Lox Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Lox Cream Cheese; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0561-2026 · 557-5lb tubs (Total)

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Scallion Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Scallion Cream Cheese; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0562-2026 · 557-5lb tubs (Total)

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Strawberry Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Strawberry Cream Cheese; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0563-2026 · 557-5lb tubs (Total)

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Sundried Tomato Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Sundried Tomato Cream Cheese; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0564-2026 · 557-5lb tubs (Total)

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Vegetable Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Vegetable Cream Cheese; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0565-2026 · 557-5lb tubs (Total)

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Walnut Raisin Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Walnut Raisin Cream Cheese; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0566-2026 · 557-5lb tubs (Total)

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Whipped Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Whipped Cream Cheese; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0567-2026 · 557-5lb tubs (Total)

Class IFoodFeb 19, 2026

Made Fresh Salads Inc: Made Fresh Salads brand Tofu Whipped; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Product, lots & distribution

Made Fresh Salads brand Tofu Whipped; 5 lb white plastic tub — Distribution: New York — Lots/codes: All expiration dates through 2/27/2026. — Status: Ongoing (voluntary: firm initiated)

H-0568-2026 · 557-5lb tubs (Total)

Class IIIFoodFeb 19, 2026

Super World Trading Inc.: MEI HEONG YUEN TANGERINE FLAVOR ROASTED PEANUTS; NET 9.17 oz (260g); Ingredients: Peanuts, Salt, Sugar, Liquorice, Spices, Sodium Cyclamate, Acesulfame-K, Vanilla, Ethyl Mal…

Products contain cyclamates (banned sweetener)

Product, lots & distribution

MEI HEONG YUEN TANGERINE FLAVOR ROASTED PEANUTS; NET 9.17 oz (260g); Ingredients: Peanuts, Salt, Sugar, Liquorice, Spices, Sodium Cyclamate, Acesulfame-K, Vanilla, Ethyl Maltol; Shelf Life: 18 Months; Manufacturer: Heshan Mei Heong Yuen Food Pte Ltd; Distributor in USA: Super World Trading Inc 28 Varick Ave. Brooklyn, NY 11237 UPC: 6912449124312 — Distribution: CO, CT, DE, FL, GA, IL, MA, MD, MI, NY, NC, NJ, OH, OR, PA, TX, UT, VA, WA — Lots/codes: MFD: 2050721, EXP 20270120, FIRM CODE: 401019 — Status: Terminated (voluntary: firm initiated)

H-0641-2026 · 595 cases (total)

Class IIIFoodFeb 19, 2026

Super World Trading Inc.: MEI HEONG YUEN WALNUT FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Liquorice, Sugar, Spices, Sodium Cyclamate, Acesulfame-K, Vanilla, Ethyl Maltol; Sh…

Products contain cyclamates (banned sweetener)

Product, lots & distribution

MEI HEONG YUEN WALNUT FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Liquorice, Sugar, Spices, Sodium Cyclamate, Acesulfame-K, Vanilla, Ethyl Maltol; Shelf Life: 18 Months; Manufacturer: Heshan Mei Heong Yuen Food Pte Ltd; Distributor in USA: Super World Trading Inc 28 Varick Ave. Brooklyn, NY 11237; UPC: 6912449124282 — Distribution: CO, CT, DE, FL, GA, IL, MA, MD, MI, NY, NC, NJ, OH, OR, PA, TX, UT, VA, WA — Lots/codes: MFD:20250717, EXP:20270116, FIRM CODE: 401020 — Status: Terminated (voluntary: firm initiated)

H-0642-2026 · 595 cases (total)

Class IIIFoodFeb 19, 2026

Super World Trading Inc.: MEI HEONG YUEN GARLIC FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Garlic, Liquorice, Sugar, Saccharin; Shelf Life: 18 Months; Manufacturer: Heshan Me…

Products contain cyclamates (banned sweetener)

Product, lots & distribution

MEI HEONG YUEN GARLIC FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Garlic, Liquorice, Sugar, Saccharin; Shelf Life: 18 Months; Manufacturer: Heshan Mei Heong Yuen Food Pte Ltd; Distributor in USA: Super World Trading Inc 28 Varick Ave. Brooklyn, NY 11237; UPC: 6912449124329 — Distribution: CO, CT, DE, FL, GA, IL, MA, MD, MI, NY, NC, NJ, OH, OR, PA, TX, UT, VA, WA — Lots/codes: MFD: 20250710, EXP:20270109, FIRM CODE: 401021 — Status: Terminated (voluntary: firm initiated)

H-0643-2026 · 595 cases (total)

Class IIIMedicationFeb 18, 2026

Cipla USA, Inc.: Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Su…

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

Product, lots & distribution

Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17 — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027 — Status: Ongoing (voluntary: firm initiated)

D-0381-2026 · 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules

Class IIIMedicationFeb 18, 2026

Cipla USA, Inc.: Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 cap…

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

Product, lots & distribution

Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17 — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 5GJ0223, Exp 04/30/2027 — Status: Ongoing (voluntary: firm initiated)

D-0382-2026 · 164 cartons

Class IIMedicationFeb 18, 2026

HTO Nevada Inc. dba Kirkman: FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.

Stability Data Does Not Support Expiry Date.

Product, lots & distribution

FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016. — Distribution: Nationwide within the U.S — Lots/codes: Lot #: 839CP-0016, Exp. Date 03/31/2026; 839CP-0017, Exp. Date 06/30/2026; 839CP-0018, Exp. Date 08/31/2026; 839CP-0019, Exp. Date 10/31/2026; 839CP-0020, Exp. Date 03/31/2027; 839CP-0021, Exp. Date 07/31/2027; 839CP-0022, Exp.Date 11/30/2027; 839CP-0023, Exp. Date 02/29/2028; 839CP-0024, Exp. Date 07/31/2028. — Status: Ongoing (voluntary: firm initiated)

D-0385-2026 · 27,380 bottles.

Class IIMedicationFeb 18, 2026

HTO Nevada Inc. dba Kirkman: MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.

Stability Data Does Not Support Expiry Date.

Product, lots & distribution

MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014. — Distribution: Nationwide within the U.S — Lots/codes: Lot #: 807CP-0003, Exp. Date 07/31/2026. — Status: Ongoing (voluntary: firm initiated)

D-0386-2026 · 178 bottles

Class IIMedicationFeb 18, 2026

HTO Nevada Inc. dba Kirkman: MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.

Stability Data Does Not Support Expiry Date.

Product, lots & distribution

MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015. — Distribution: Nationwide within the U.S — Lots/codes: Lot #: 795CP-0005, Exp. Date 06/30/2026 — Status: Ongoing (voluntary: firm initiated)

D-0387-2026 · 243 bottles

Class IIFoodFeb 18, 2026

NRS Enterprises, Inc. dba Sunflour Bakery: Sunflour Bakery Hamburger Bun, 18oz plastic bag containing 6 buns. UPC- 832971001522

Undeclared sesame seed ingredient in hamburger buns.

Product, lots & distribution

Sunflour Bakery Hamburger Bun, 18oz plastic bag containing 6 buns. UPC- 832971001522 — Distribution: Product was distributed to one local retail consignee in the Orange County area. — Lots/codes: Expiration date: 02/24/2026 — Status: Ongoing (voluntary: firm initiated)

H-0603-2026 · 1 bag

Class IIMedicationFeb 17, 2026

The Harvard Drug Group LLC: Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC…

Defective container; inadequately sealed blister packaging.

Product, lots & distribution

Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06. — Distribution: Nationwide US. — Lots/codes: Lot # N02640, Exp Date: 08/2027 — Status: Ongoing (voluntary: firm initiated)

D-0383-2026 · 8892 cartons

Class IIFoodFeb 17, 2026

Wawa Beverage Company: Wawa Reduced Fat Milk 2% 16 oz (Pint)

Foreign plastic material discovered on fill line.

Product, lots & distribution

Wawa Reduced Fat Milk 2% 16 oz (Pint) — Distribution: The recalled product was distributed to the following States: NJ,MD, DE, PA — Lots/codes: UPC: 0072619101438 — Status: Terminated (voluntary: firm initiated)

H-0585-2026 · 5456 units total

Class IIFoodFeb 17, 2026

Wawa Beverage Company: Wawa Double Dutch Chocolate Milk ,16 oz (Pint) Plastic bottle Store Refrigerated

Foreign plastic material discovered on fill line.

Product, lots & distribution

Wawa Double Dutch Chocolate Milk ,16 oz (Pint) Plastic bottle Store Refrigerated — Distribution: The recalled product was distributed to the following States: NJ,MD, DE, PA — Lots/codes: UPC: 007261910 — Status: Terminated (voluntary: firm initiated)

H-0586-2026 · 5456 units total

Class IIFoodFeb 17, 2026

Wawa Beverage Company: Wawa Cookies & Cream Milk 16 oz (Pint), Plastic bottle Store Refrigerated

Foreign plastic material discovered on fill line.

Product, lots & distribution

Wawa Cookies & Cream Milk 16 oz (Pint), Plastic bottle Store Refrigerated — Distribution: The recalled product was distributed to the following States: NJ,MD, DE, PA — Lots/codes: UPC: 0072619015158 — Status: Terminated (voluntary: firm initiated)

H-0587-2026 · 5456 units total

Class IIFoodFeb 17, 2026

Wawa Beverage Company: Wawa Chocolate Low-fat Milk 16 oz , (Pint) Plastic bottle .Store Refrigerated

Foreign plastic material discovered on fill line.

Product, lots & distribution

Wawa Chocolate Low-fat Milk 16 oz , (Pint) Plastic bottle .Store Refrigerated — Distribution: The recalled product was distributed to the following States: NJ,MD, DE, PA — Lots/codes: UPC: 00726191014908 — Status: Terminated (voluntary: firm initiated)

H-0588-2026 · 5456 units total

Class IIFoodFeb 14, 2026

Ganesha Enterprises LLC: KLG, Kesar Mukhwas, perishable, 24 months, flexible plastic, 200 gm, 818812022208, Ganesha Enterprises LLC, 5200 Sigstrom Drive, Carson City, Nevada 89706 USA.

Undeclared food colorings (Yellow 6, Blue 1, and Yellow 5) and unapproved Acid Red 14.

Product, lots & distribution

KLG, Kesar Mukhwas, perishable, 24 months, flexible plastic, 200 gm, 818812022208, Ganesha Enterprises LLC, 5200 Sigstrom Drive, Carson City, Nevada 89706 USA. — Distribution: Product was distributed in the following states: CA, GA, IL, NY, and TN. — Lots/codes: IKS265, 07/2027 — Status: Ongoing (voluntary: firm initiated)

H-0683-2026 · 347 pieces/ 200 gm pouch

Class IIMedicationFeb 13, 2026

AvKARE: Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.

Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.

Product, lots & distribution

Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15. — Distribution: Nationwide in the USA. — Lots/codes: Lot # 49261, Exp: 04/30/27 — Status: Ongoing (voluntary: firm initiated)

D-0341-2026 · N/A

Class IIMedicationFeb 13, 2026

Harbin Jixianglong Biotech Co., Ltd.: Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50…

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

Product, lots & distribution

Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China — Distribution: Nationwide within the United States — Lots/codes: Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027 — Status: Ongoing (voluntary: firm initiated)

D-0379-2026 · N/A

Class IIMedicationFeb 13, 2026

Harbin Jixianglong Biotech Co., Ltd.: Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50…

CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution

Product, lots & distribution

Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China. — Distribution: Nationwide within the United States — Lots/codes: Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027. — Status: Ongoing (voluntary: firm initiated)

D-0380-2026 · N/A

Class IFoodFeb 13, 2026

Ambrosia Brands LLC: Rosabella brand MORINGA; DIETARY SUPPLEMENT CAPSULES; 60 capsules per bottle; Distributed by: Ambrosia Brands, LLC, 625 Randall Ave, St. 100, Cheyenne, WY 82001; SUGGESTED USE: A…

Product may be contaminated with Salmonella

Product, lots & distribution

Rosabella brand MORINGA; DIETARY SUPPLEMENT CAPSULES; 60 capsules per bottle; Distributed by: Ambrosia Brands, LLC, 625 Randall Ave, St. 100, Cheyenne, WY 82001; SUGGESTED USE: As a dietary supplement, take two (2) veggie capsules once a day. For best results, take 20-30 min before a meal with an 8oz. glass of water or as directed by your health professional; UPC: 8 60012 16172 0 — Distribution: Nationwide in the United States, including American Samoa, Northern Mariana Islands, Puerto Rico, and Virgin Islands. International distribution to consumers in: Algeria, Anguilla, Australia, Austria, Bahrain, Belgium, Bosnia and Herzegovi… — Lots/codes: Lot # - Expiration Date: 5020591 - 03/2027 5020592 - 03/2027 5020593 - 03/2027 5020594 - 03/2027 5020595 - 03/2027 5020596 - 03/2027 5030246 - 04/2027 5030247 - 04/2027 5030248 - 04/2027 5030249 - 04/2027 5030250 - 04/2027 5030251 - 04/2027 5040270 - 05/2027 5040271 - 05/2027 5040272 - 05/2027 5040273 - 05/2027 5040274 - 05/2027 5040275 - 05/2027 5040276 - 05/2027 5040277 - 05/2027 5040278 - 05/2027 5040279 - 05/2027 5050053 - 6/2027 5050054 - 6/2027 5050055 - 6/2027 5050056 - 6/2027 5060069 - 07/2027 5060070 - 07/2027 5060071 - 07/2027 5060072 - 07/2027 5060073 - 07/2027 5060074 - 07/2027 50… — Status: Ongoing (voluntary: firm initiated)

H-0546-2026 · 1,224,208 units

Class IFoodFeb 13, 2026

Shaman Botanicals, LLC: Product label reads in part as "WHITE VEIN ADVANCED ALKALOIDS CHEWABLE TABLETS 15mg 7-Hydroxymitragynine per container (7.5mg 7-OH per serving) LEMON DIETARY SUPPLEMENT Net Wt…

A sample of the product had the active ingredient in a quantity greater than the labeled specification.

Product, lots & distribution

Product label reads in part as "WHITE VEIN ADVANCED ALKALOIDS CHEWABLE TABLETS 15mg 7-Hydroxymitragynine per container (7.5mg 7-OH per serving) LEMON DIETARY SUPPLEMENT Net Wt. 0.02 oz 2 TABLETS Supplement Facts 7-hydroxymitragynine 7.5 mg MANUFACTURED BY: Konig Products, LLC 30 N Gould Street, Suite R, Sheridan, WY 82801"; Packaging: Sealed silver metallic bag with a front and back sticker for the labels; Product label reads in part as "WHITE VEIN ADVANCED ALKALOIDS CHEWABLE TABLETS 150mg total 7-Hydroxymitragynine per container (10 Packets x 2 Tablets Each) 7.5mg 7-OH per tablet/serving, LEMON DIETARY SUPPLEMENT Net Wt. 0.17 oz 10 PACKETS 2 TABLETS EACH Supplement Facts 7-hydroxymitragynine 7.5 mg MANUFACTURED BY: Konig Products, LLC 30 N Gould Street, Suite R, Sheridan, WY 82801"; Packaging: Sealed black flexible plastic bag with multi color sticker label on front and back UPC 810057763724 — Distribution: Firm has provided the following information: 14 wholesalers, 108 Distributors, 46 Company-owned stores, 2202 online customers — Lots/codes: B#AAW.501.3; all expiration dates — Status: Ongoing (voluntary: firm initiated)

H-1107-2026 · 2 pack: 1281 units; 20-count: 14,491 units

Class IFoodFeb 13, 2026

Shaman Botanicals, LLC: Product label reads in part as "WHITE VEIN ADVANCED ALKALOIDS CHEWABLE TABLETS 225mg 7-Hydroxymitragynine per container (7.5mg 7-OH per serving) LEMON DIETARY SUPPLEMENT Net W…

A sample of the product revealed the active ingredient is in a quantity greater than the labeled specification.

Product, lots & distribution

Product label reads in part as "WHITE VEIN ADVANCED ALKALOIDS CHEWABLE TABLETS 225mg 7-Hydroxymitragynine per container (7.5mg 7-OH per serving) LEMON DIETARY SUPPLEMENT Net Wt. 0.25 oz 30 TABLETS Supplement Facts 7-hydroxymitragynine 7.5 mg MANUFACTURED BY: Konig Products, LLC 30 N Gould Street, Suite R, Sheridan, WY 82801"; Packaging: White child-resistant plastic bottle with sticker label applied UPC 810057763779 (sometimes proceeded by 00) — Distribution: Firm has provided the following information: 14 wholesalers, 108 Distributors, 46 Company-owned stores, 2202 online customers — Lots/codes: B#AAW.501.3; all expiration dates — Status: Ongoing (voluntary: firm initiated)

H-1108-2026 · 97,063 units

Class IIIMedicationFeb 12, 2026

Slate Run Pharmaceuticals: Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm…

Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.

Product, lots & distribution

Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80 — Distribution: Nationwide within the USA. — Lots/codes: All lots within expiry — Status: Ongoing (voluntary: firm initiated)

D-0343-2026 · N/A

Class IFoodFeb 12, 2026

Oregon Potato Company LLC: IQF Blueberry (30lbs. cases and 1400 lbs. totes), product of USA. Product is packaged in polyethylene bag within a corrugated 30lbs. case or packaged in polyethylene liner…

Listeria monocytogenes

Product, lots & distribution

IQF Blueberry (30lbs. cases and 1400 lbs. totes), product of USA. Product is packaged in polyethylene bag within a corrugated 30lbs. case or packaged in polyethylene liner within a Gaylord 1400lbs. tote. Product was not sold to consumers from retail stores. Willamette Valley Fruit Company 2994 82nd Ave. NE Salem OR 97305 — Distribution: Distributed in MI, OR, WA, WI and in Canada. — Lots/codes: Lot codes on 30 lbs. CASES: 2055 B2, 2065 B1, and 2065 B3. Lot codes on 1400 lbs. TOTES: 3305 A1 and 3305 B1. Expiration dates or best-by date: 2055 B2 expiration 7/23/2027 2065 B1 expiration 7/24/2027 2065 B3 expiration 7/24/2027 3305 A1 expiration 11/25/2027 3305 B1 expiration 11/25/2027 — Status: Ongoing (voluntary: firm initiated)

H-0522-2026 · 55,689 lbs.

Class IIFoodFeb 12, 2026

SUNGAL INC: XZL, Jelly Snacks, 12.68 OZ, Bag. 12 Bags per Case.

Product Contains undeclared FD&C Yellow #5 & #6 and Red #40

Product, lots & distribution

XZL, Jelly Snacks, 12.68 OZ, Bag. 12 Bags per Case. — Distribution: The product was distributed to the following states : NY, RI — Lots/codes: UPC CODE 6926475202449 — Status: Terminated (voluntary: firm initiated)

H-0689-2026 · 100 Cases

Class IFoodFeb 11, 2026

Juniper Granola, LLC: Junebar Peanut Chocolate Chip All Natural Snack Bar; INGREDIENTS: ORGANIC PEANUT BUTTER, DATE PASTE, ORGANIC BLACK BEANS, ORGANIC SWEET POTATOES, GLUTEN FREE ROLLED OATS, SEMI-S…

Products contain undeclared milk and soy.

Product, lots & distribution

Junebar Peanut Chocolate Chip All Natural Snack Bar; INGREDIENTS: ORGANIC PEANUT BUTTER, DATE PASTE, ORGANIC BLACK BEANS, ORGANIC SWEET POTATOES, GLUTEN FREE ROLLED OATS, SEMI-SWEET SOY FREE VEGAN SHOCOLATE CHIPS (ORGANIC CANE SUGAR, UNSWEETENED CHOCOLATE, COCOA BUTTER), PEANUTS, OAT FLOUR, VANILLA EXTRACT (VANILLA BEAN EXTRATIVES IN WATER, ALCOHOL), FLAX, CINNAMON, SEA SALT, BAKING POWDER; ALLERGEN WARNING: CONTAINS PEANUTS, TREE NUTS (ALMOND, COCONUT), PRODUCED ON EQUIPMENT ALSO HANDLING PEANUT, SESAME, PRODUCED IN A FACILITY THAT ALSO PROCESSES GLUTEN PRODUCTS. KEEP REFRIGERATED.; UPC 8 60012 38461 7 — Distribution: New York — Lots/codes: Lot L1300, including L1300A and L1300B. Lot number is stamped on the back, near the bottom of each individual bar pouch. — Status: Terminated (voluntary: firm initiated)

H-0542-2026 · 1800 bars total

Class IFoodFeb 11, 2026

Juniper Granola, LLC: Junebar Chocolate Cherry All Natural Snack Bar; INGREDIENTS: ORGANIC ALMOND BUTTER, DATE PASTE, ORGANIC BLACK BEANS, ORGANIC SWEET POTATOES, GLUTEN FREE ROLLED OATS, SEMI-SWEET…

Products contain undeclared milk and soy.

Product, lots & distribution

Junebar Chocolate Cherry All Natural Snack Bar; INGREDIENTS: ORGANIC ALMOND BUTTER, DATE PASTE, ORGANIC BLACK BEANS, ORGANIC SWEET POTATOES, GLUTEN FREE ROLLED OATS, SEMI-SWEET SOY FREE VEGAN CHOCOLATE CHIPS (ORGANIC CANE SUGAR, UNSWEETENED CHOCOLATE, COCOA BUTTER), DRIED CHERRIES, ALMONDS; OAT FLOUR, COCOA POWDER, ORANGE ZEST, VANILLA EXTRACT (VANILLA BEAN EXTRACTIVES IN WATER, ALCOHOL), FLAX, CINNAMON, SEA SALT, BAKING POWDER; ALLERGEN WARNING: CONTAINS TREE NUTS (ALMOND, COCONUT), PRODUCED ON EQUPMENT ALSO HANDLING PEANUT, SESAME. PRODUCED IN A FACILITY THAT ALSO PROCESES GLUTEN PRODUCTS. KEEP REFRIGERATED; UPC: 8 60012 38462 4 — Distribution: New York — Lots/codes: Lot L1300, including L1300A and L1300B. Lot number is stamped on the back, near the bottom of each individual bar pouch. — Status: Terminated (voluntary: firm initiated)

H-0543-2026 · 1800 bars total

Class IIMedicationFeb 10, 2026

LEO PHARMA INC: Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-0…

Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.

Product, lots & distribution

Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Pharma A/S. Industriparken 55, DK-2750 Ballerup, Denmark, Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA, — Distribution: Nationwide in the USA — Lots/codes: Lot: a) 003E24C, Exp 04/30/2027; b) 003E24A, Exp 04/30/2027. — Status: Ongoing (voluntary: firm initiated)

D-0339-2026 · 11,407 units

Class IIFoodFeb 10, 2026

Italianway Import, Inc.: VERGANI 1944 MILANO 'PANDORO CLASSICO' Gluten Free, 600g NET WT. 1 LBS. 5.2 OZ., packaged in paper cartons, 6 units per case. Lot 217666, UPC 8002114019833

Potential contamination with foreign material (Teflon fragments) from flaking cooking molds.

Product, lots & distribution

VERGANI 1944 MILANO 'PANDORO CLASSICO' Gluten Free, 600g NET WT. 1 LBS. 5.2 OZ., packaged in paper cartons, 6 units per case. Lot 217666, UPC 8002114019833 — Distribution: Distributed in: FL, MI, NJ — Lots/codes: Lot code: L217666 Expiration: 04/08/2026 — Status: Terminated (voluntary: firm initiated)

H-0540-2026 · 10 cases (6 units/ case) Total: 60 units (600g each)

Class IIFoodFeb 10, 2026

SLADE GORTON & CO., INC.: Wellsley Farms Farm- Raised Atlantic Salmon Net WT. 32 oz. (2 lbs.) 907 g

Contaminated with Listeria monocytogenes

Product, lots & distribution

Wellsley Farms Farm- Raised Atlantic Salmon Net WT. 32 oz. (2 lbs.) 907 g — Distribution: MD — Lots/codes: Lot 3896 Prod June 30, 2025, BB June 30, 2027 UPC Code: 888670025963 — Status: Ongoing (voluntary: firm initiated)

H-0541-2026 · 190 cases

Class IIMedicationFeb 9, 2026

Meitheal Pharmaceuticals, Inc: Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90.

Defective Delivery System: Missing or duplicated needles within the injection kit

Product, lots & distribution

Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx Only, Mfd. for: Meitheal Pharmaceuticals, Chicago, IL NDC 71288-558-90. — Distribution: U.S. Nationwide — Lots/codes: Lot Q4E0112A, Exp.: 30 Apr 2027 — Status: Ongoing (voluntary: firm initiated)

D-0340-2026 · 16,477 kits

Class IIFoodFeb 9, 2026

H & N Group Inc.: Frozen Cooked Medium Shrimp Peeled & Deveined, Tail Off-White Shrimp; 1 lbs retail plastic bag. UPC: 041220333035

Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)

Product, lots & distribution

Frozen Cooked Medium Shrimp Peeled & Deveined, Tail Off-White Shrimp; 1 lbs retail plastic bag. UPC: 041220333035 — Distribution: Product was distributed to a single retail consignee with multiple locations (~30) in the greater Houston and Gulf Coast areas. — Lots/codes: " Lot EA14 25118, bearing a Best By date of October 28, 2026 " Lot EA14 25119, bearing a Best By date of October 29, 2026 — Status: Terminated (voluntary: firm initiated)

H-0516-2026 · 378 cases (3,780 units)

Class IIFoodFeb 9, 2026

Polski Ogrod Sp. z o.o.: Hortex Mieszanka 9 - skBadnikowa Spring vegetable mix with 9 ingredients, net wt 15.87oz., UPC 5 900477 018735 >, 14 units per case

potential contamination with glass

Product, lots & distribution

Hortex Mieszanka 9 - skBadnikowa Spring vegetable mix with 9 ingredients, net wt 15.87oz., UPC 5 900477 018735 >, 14 units per case — Distribution: IL — Lots/codes: LOT: SoC1070925 — Status: Terminated (voluntary: firm initiated)

H-0549-2026 · 1134 units

Class IFoodFeb 8, 2026

Perfect Pasta, Incorporated: Lobster & Crab Ravioli. Keep Frozen. Contains: Wheat, Eggs, Milk, Crustaceans-Shellfish. Product is intended to be further cooked. Weight: 1-10 pound (4.5g). Use within 6…

Undeclared shrimp, crab, lobster, pollock (fish), whiting (fish), and soy.

Product, lots & distribution

Lobster & Crab Ravioli. Keep Frozen. Contains: Wheat, Eggs, Milk, Crustaceans-Shellfish. Product is intended to be further cooked. Weight: 1-10 pound (4.5g). Use within 6 months. 801-541-9292-www.FunarosPerfectPasta.com. 1391 So. 300 West Slc, Ut 84115. — Distribution: Distributed to consignees in Utah only. — Lots/codes: Made on: JAN 19 2026 — Status: Terminated (voluntary: firm initiated)

H-0620-2026 · 42/ 10 lb cases

Class IIFoodFeb 6, 2026

Valley Springs Artesian Gold, LLC: Valley Springs 100% Natural Bottled Water packaged in the following size plastic jug with plastic caps: 1. 1 Gal Net 128 Fl oz. UPC 0 31193-00701 9. Bottled by Vall…

Water was bottled under insanitary conditions.

Product, lots & distribution

Valley Springs 100% Natural Bottled Water packaged in the following size plastic jug with plastic caps: 1. 1 Gal Net 128 Fl oz. UPC 0 31193-00701 9. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 2. 2.5 Gallon Net (320 Fl oz./9.4L). UPC 0 31193-01501 4. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 3. Infant Water, 1 Gal Net, 128 FL. Oz. Not sterile. Use as directed by physician or by labeling directions for use of infant formula. UPC 0 31193-01401 7. 4. Daisy's Doggy Water, 1 Gal Net, 128 FL. Oz. 100% Pure Water. No Chlorine. UPC 0 31193-90100 3. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. Distributed by DDW LLC, 109 S. Thompson Rd., Sun Prairie, WI 53590. — Distribution: IL, WI — Lots/codes: All Codes — Status: Ongoing (voluntary: firm initiated)

H-0534-2026 · 379,868 units

Class IIFoodFeb 6, 2026

Valley Springs Artesian Gold, LLC: Valley Springs 100% Natural Bottled Water. Fluoride Added. 1 Gal Net, 128 Fl. Oz. UPC 0 31193-01301 0. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 5390…

Water was bottled under insanitary conditions.

Product, lots & distribution

Valley Springs 100% Natural Bottled Water. Fluoride Added. 1 Gal Net, 128 Fl. Oz. UPC 0 31193-01301 0. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. — Distribution: IL, WI — Lots/codes: All Codes — Status: Ongoing (voluntary: firm initiated)

H-0535-2026 · 7,840 units

Class IIFoodFeb 6, 2026

Valley Springs Artesian Gold, LLC: Valley Springs Steamed Distilled Water. 1 Gal Net, 128 Fl. Oz. UPC 0 31193-00601 2. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901.

Water was bottled under insanitary conditions.

Product, lots & distribution

Valley Springs Steamed Distilled Water. 1 Gal Net, 128 Fl. Oz. UPC 0 31193-00601 2. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. — Distribution: IL, WI — Lots/codes: All Codes — Status: Ongoing (voluntary: firm initiated)

H-0536-2026 · 263,440 units

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