FDA Recalls in 2025

Mai California Roll WR - UPC 840031402639 5.9 oz (167g) Plastic tray with plastic lid

Wheat and Soy missing allergens from the product Contains Statement.

Peach Salsa - $5.99-16 oz 639123940636 packaged in clear plastic clamshells Sell by 11/3/2025 Sell by 11/4/2025

Peaches provided by Moonlight Peaches potentially contaminated with Listeria.

Product Name: Nutra Calm Package: 175cc HDPE Bottle. Type: Vegetable Capsule Count: 90, Dose: 2 Capsules. Product Sku: PB248

Products contains Magnesium Salicylate.

Peach Salsa; UPC 85006540364 14oz (397g); Use by 10/12/2025 to 10/29/2025

Peaches provided by Moonlight Peaches potentially contaminated with Listeria.

Product Name: Total Comfort. Package: 175cc HDPE Bottle. Type: Vegetable Capsule Count: 60, Dose: 2 Capsules. Product Sku: PB173.

Products contains Magnesium Salicylate.

Carton Label: PACIFIC STRAIGHT FROM THE FIELDS FRESH HERBS 4/24 BUNCH ITALIAN PARSLEY BAGS PRODUCE OF U.S.A. PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 Carton Sticker Label: Conv Italian Parsley 4/24 CT Display Pacific Product of USA Distributed By: Dynasty Farms Salinas, CA 93905 UPC 40695 80120 Plastic Bag Label: ITALIAN PARSLEY CONTAINS 24 BUNCHES OF ITALIAN PARSLEY PRODUCE OF U.S.A. Distributed By: Pacific International Marketing P.O. Box 3737 Salinas, CA 93912 www.pim4u.com Plast

Potential contamination with Salmonella.

LO-BOY FOODS; TUNA DELUXE; packaged in 5lb white plastic tubs

Products may be contaminated with Listeria monocytogenes.

Carton Label: PACIFIC FRESH VEGETABLES PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 PRODUCE OF U.S.A. Sticker Label: Conv Italian Parsley 30 Ct Iceless Pacific Product of USA Distributed By: Dynasty Farms Salinas, CA 93905 Twist Tie (for bunches) Label: FLAT PARSLEY PLU #4901 PROUDCT OF USA UPC 40695 80125

Potential contamination with Salmonella.

Zingerman's Peanut Butter Crush Candy Bar net wt 2oz UPC 844397005237

Undeclared cashew

Blue Oven Artisan Bakery English Muffins, Net Wt. 13.4 oz (380g), packaged as a 4-pack in a clear plastic bag, UPC 198715684322

Undeclared allergen - milk

Monarch Premium Kratom Green Maeng Da powder is packaged in seal mylar pouches: Monarch Premium Kratom Green Maeng Da, 4oz powder (112g), UPC 851006008466 Monarch Premium Kratom Green Maeng Da, 0.5oz powder (14g), UPC 851006008770 Monarch Premium Kratom Green Maeng Da, 2oz powder (56g), UPC 851006008459

Product has the potential to be contaminated with Salmonella

Monarch Premium Kratom White Elephant powder is packaged in seal mylar pouches: Monarch Premium Kratom, White Elephant, 4oz powder (112g), UPC 851006008480 Monarch Premium Kratom, White Elephant, 0.5oz powder (14g), UPC 851006008756 Monarch Premium Kratom, White Elephant, 8oz powder (224g), UPC 706970483644

Product has the potential to be contaminated with Salmonella

Roshni Cinnamon Powder, 3.5 oz (100g). This product is packaged in clear plastic pouches.

Product may contain elevated levels of lead and chromium.

Loaded Veggie Grain Bowl; Net Wt. 10.90 Oz (309g) GTIN code: 00818905028162

Potential contamination with Listeria monocytogenes

Zingerman's Ca$hew Cow Candy Bar net wt 2oz UPC 844397000157

Undeclared peanut

Product Name: Tense-X. Package: 175cc HDPE Bottle. Type: Vegetable Capsule. Count: 60. Dose: 2 Capsules. Product Sku: PB207

Products contains Magnesium Salicylate.

LO-BOY FOODS; MACARONI SALAD; packaged in 5lb white plastic tubs

Products may be contaminated with Listeria monocytogenes.

Carton Label: PACIFIC FRESH VEGETABLES PACIFIC INTERNATIONAL MARKETING SALINAS, CA 93912 Carton Sticker Label: Conv Italian Parsley 60 Ct Iceless Pacific Product of USA Distributed By: Dynasty Farms Salinas, CA 93905 UPC 40695 80125 Twist Tie (for bunches) Label: FLAT PARSLEY PLU #4901 PROUDCT OF USA UPC 40695 80125

Potential contamination with Salmonella.

Monarch Premium Kratom Red Bali powder is packaged in seal mylar pouches: Monarch Premium Kratom Red Bali, 4oz powder (112g), UPC 851006008442 Monarch Premium Kratom Red Bali, 8oz powder (224g), UPC 706970483859 Monarch Premium Kratom Red Bali, 2oz powder (56g), UPC 851006008435

Product has the potential to be contaminated with Salmonella

Monarch Premium Kratom Bali Gold powder is packaged in seal mylar pouches: Monarch Premium Kratom Bali Gold, 4oz powder (112g), UPC 851006008428 Monarch Premium Kratom Bali Gold, 8oz powder (224g), UPC 706970483712

Product has the potential to be contaminated with Salmonella

Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw

Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.

Ulrich notified initially notified customers, via phone call, on 12/20/2019. On about 12/31/2019, customers were also sent an official "URGENT SAFETY INFORMATION: MEDICAL DEVICE CORRECTIONS & REMOVALS" letter. Customers were informed that the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation. Instructions included cease use of the affected devices, return them to Ulrich, and complete and return the provided "Product Recall" form. Customers were also instructed to inform all users of the devices within each organization are informed. Questions or concerns can be directed to Mr. Louis Milos, Sr. Manager Business and Quality Systems, at 636-519-0268 ext. 105, l.milos@ulrichmedicalusa.com, Monday through Friday 8:00am to 5:00pm CST.

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.

Subpotent drug; Clavulanate Potassium component

Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-01

Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.

clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Kroger Mercado Cooked Medium Peeled Tail-Off Shrimp, net wt. 2lbs. UPC 011110626196. Product is packaged in clear plastic bag and has a white label with green stripes on top of each bag.

Shrimp may be contaminated with Cesium-137 (Cs-137).

AquaStar 16/20 Frozen Raw EZ-Peel White Shrimp, net wt. 5 lbs. UPC 731149654075. Product was sold at WinCo.

Shrimp may be contaminated with Cesium-137 (Cs-137).

Frozen Crab Paste; 3.5 OZ (100g); Imported by Mutual Tading Co. Inc. UPC# 72546723040 "Not for retail Sale" Frozen Crab Paste IM-2 in w/Tray; 500g; Imported by Mutual Trading Co. Inc. UPC# 72546607852 "Not for retail Sale" Frozen Crab Paste; 17.6 OZ (500g); Imported by Mutual Tading Co. Inc. UPC# 72546607852 "Not for retail Sale"

Undeclared allergen ingredients (fish, soy, and wheat)

Waterfront Bistro Frozen Raw EZ-Peel White Shrimp 21/25, net wt. 2lbs., UPC 021130123223. Product was sold at Shaw s and Star Market, Albertson's, Eagle, Carrs-Safeway, and Safeway.

Shrimp may be contaminated with Cesium-137 (Cs-137).

Specialty Stuft Meats Crawfish Stuft Potato, Net Wt .72 lbs, individually packaged in vacuum-sealed plastic, UPC 642176000172

Undeclared Yellow 5, Yellow 6

Eagle Spice Ground Ginger 16 oz.

Contains elevated levels of lead (Pb)

Dr. Praeger's, California Veggie Burgers, 10oz, Plastic wrapped burgers inside of a retail box. 6 packages per master case. Keep Frozen

Product was made on equipment that test positive for Listeria .

Casa Mamita Soft Taco Dinner Kit, Net Wt 13.4 OZ (379g), UPC: 4099100318715, DIST. & SOLD EXCLUSIVELY BY: ALDI BATAVIA, IL 60510 Product consists of 10 flour tortillas, 1 sauce packet, and 1 seasoning packet within a carton; 6 cartons are packed into a mixed case with 6 additional hard taco dinner kits

Undeclared allergen - milk

AquaStar 13/15 Raw Shrimp Easy Peel Deveined, net wt. 2 lbs. UPC 731149654051. Product was sold at Publix.

Shrimp may be contaminated with Cesium-137 (Cs-137).

Publix Large Shrimp Peeled & Deveined Tail On 31/40, net wt. 1.5 lbs. UPC 041415067455. Product was sold at Publix.

Shrimp may be contaminated with Cesium-137 (Cs-137).

Publix Extra Large Shrimp Easy to Peel Deveined 21/25, net wt. 1.5 lbs. UPC 041415064454. Product was sold at Publix.

Shrimp may be contaminated with Cesium-137 (Cs-137).

" Product Name: Pastured Grade AA Large Eggs " Product Description: Egg Carton, 12 eggs per dozen " Pack/Julian Date(s): Julian date 241(Aug 30) to 244 (Sep 2) and 246 (Sep 4) to 247 (Sep 5), Best by Dates 10/11 to 10/14/25 and 10/16 to 10/17.

Eggs may be contaminated with Salmonella.

AquaStar Raw Peeled Tail-on Shrimp Skewers, net wt. 1.25lbs. UPC 731149390010. Product is packaged in a printed bag with a black top and blue bottom and printed pictures of the skewers inside.

Shrimp may be contaminated with Cesium-137 (Cs-137).

In-shell chicken eggs distributed on Jacob King's farm in Addison, NY

Product may be contaminated with Salmonella

Kroger Raw Colossal EZ Peel Shrimp, net wt. 2lbs., UPC 20011110643906. Product is packaged in transparent printed bag with a blue band on the top with yellow and red details.

Shrimp may be contaminated with Cesium-137 (Cs-137).

Frozen Coconut bar Net wt. 4oz (113g) single bars packed in a plastic cup. UPC: 61058590845. Crafted by Fruitique International Miami USA 33016. Phone 1(888)960-6024

Undeclared sulfites in product label.

Giant/Martin's Crunchy Taco Dinner Kit, Net Wt 9.4 OZ (266g), UPC: 068826757516, DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC SALISBURY, NC 28147 Product consists of 12 taco shells, 1 sauce packet, and 1 seasoning packet within a carton; packed 12 cartons per case

Undeclared allergen - milk

Big Y Brown Jumbo A 12ct Eggs; UPC: 018894319146 Simple Truth Cage Free Brown Large AA 12ct; UPC: 011110797698 Stater Bros Cage Free Large AA 18ct; 074175001650 That's Smart Cage Free Large AA 60ct; 193476006192 Lindsey s Gold Free Range Brown Large A 12ct; 860011334408 Marketside Cage Free Brown Large A 12ct; 681131122764

Firm received, repackaged eggs that are potentially contamination with Salmonella.

Best Yet Frozen Raw EZ-Peel White Shrimp 16/20 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700282 Best Yet Frozen Raw EZ-Peel White Shrimp 21/25 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700286 Best Yet Frozen Raw EZ-Peel White Shrimp 26/30 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700283 Best Yet Frozen Raw EZ-Peel White Shrimp 31/40 (net wt. 1 lbs/pkg; 10 pkgs per case). UPC 04218700287 Best Yet Frozen Raw EZ-Peel White Shrimp 41/50 (net wt. 1 lbs/pkg; 10 pkgs per cas

Shrimp may be contaminated with Cesium-137 (Cs-137).

Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04

Lack of Assurance of Sterility

Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08

Lack of Assurance of Sterility

Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0379-01

CGMP Deviations: Potential presence of metal particulate matter

Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10

CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-06

Lack of Assurance of Sterility