États-Unis Recalls

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.

Lack of Assurance of Sterility

Zarlengo's Chocolate Chocolate Chip Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups, 1-gallon bucket/pail and 2-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and round Polyethylene terephthalate cup with peelable paper lid, laminated with heat-sealable plastic, 16 fl oz cups and 32 fl oz cups translucent freezer grade and round High-Density Polyethylene container with lid and 1-Gallon and 2-Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid.

Zarlengo Italian Ice

Apr 15, 2026Zarlengo Italian Ice

Zarlengo's Chocolate Chocolate Chip Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups, 1-gallon bucket/pail and 2-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and round Polyethylene terephthalate cup with peelable paper lid, laminated with heat-sealable plastic, 16 fl oz cups and 32 fl oz cups translucent freezer grade and round High-Density Polyethylene container with lid and 1-Gallon and 2-Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid.

Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.

MEI YU CHENG DA TRADING INC

Olive Skewers individually wrapped and packaged in clear plastic bag; 500g; INGREDIENTS: Olive, edible salt, white sugar, monosodium glutamate, licorice, cloves, food additives (citric acid, DL malic acid, saccharin, sodium saccharin, steviol glycosides, aspartame, vanillin, ethyl malt powder, lemon yellow, carmine, sodium benzoate, potassium sorbate, sodium metabisulfite); MANUFACTURER: Fuzhou Hangzhengiou food Co. Ltd; UPC: 6 922279 985205

FDA FoodClass III

Olive Skewers individually wrapped and packaged in clear plastic bag; 500g; INGREDIENTS: Olive, edible salt, white sugar, monosodium glutamate, licorice, cloves, food additives (citric acid, DL malic acid, saccharin, sodium saccharin, steviol glycosides, aspartame, vanillin, ethyl malt powder, lemon yellow, carmine, sodium benzoate, potassium sorbate, sodium metabisulfite); MANUFACTURER: Fuzhou Hangzhengiou food Co. Ltd; UPC: 6 922279 985205

Products contain banned sweetener: cyclamates.

Apr 15, 2026MEI YU CHENG DA TRADING INC

5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.

5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.

Lack of Assurance of Sterility

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).

Lack of Assurance of Sterility

Apr 15, 2026Medline Industries, LP

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107; 18. CATH SET UP PACK, Medline SKU DYNJ46711O

Medline Industries, LP

FDA DevicesClass I

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107; 18. CATH SET UP PACK, Medline SKU DYNJ46711O

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwich, perishable, Keep Refrigerated, plastic clamshell, net wt. 10 oz, UPC 8 26766 25036 3. Distributed By F&S Fresh Foods Vineland, NJ 08360. Label declares CONTAINS EGG, MILK, SOY, WHEAT.

F&S Fresh Foods, Inc.

Apr 15, 2026F&S Fresh Foods, Inc.

ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwich, perishable, Keep Refrigerated, plastic clamshell, net wt. 10 oz, UPC 8 26766 25036 3. Distributed By F&S Fresh Foods Vineland, NJ 08360. Label declares CONTAINS EGG, MILK, SOY, WHEAT.

Undeclared sesame. Sandwich contains visible sesame but label does not declare sesame.

Preferred Pharmaceuticals, Inc.

Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0

Apr 15, 2026Preferred Pharmaceuticals, Inc.

Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0

Lack of Assurance of Sterility

Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67

Cipla USA, Inc.

Apr 15, 2026Cipla USA, Inc.

Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.

0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.

Lack of Assurance of Sterility

Apr 15, 2026AYCO FARMS INC

Fresh Cantaloupe (Whole, Fresh), brand name Ayco, wrapped in food safe plastic bags packed in corrugated cardboard cartons; 6-12 melons per box; individual carton count per label. Keep refrigerated; store between 36 40¿F.

AYCO FARMS INC

FDA FoodClass I

Fresh Cantaloupe (Whole, Fresh), brand name Ayco, wrapped in food safe plastic bags packed in corrugated cardboard cartons; 6-12 melons per box; individual carton count per label. Keep refrigerated; store between 36 40¿F.

Potential Salmonella Contamination

Apr 15, 2026Medline Industries, LP

NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017.

Medline Industries, LP

FDA DevicesClass I

NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80083007; 5. SYRINGE,8,ML,TR/FR,RA,W/RES,OEM,PG, Medline SKU 80084007; 6. MTO,SYRINGE,8,ML,TR/FR,RA,NO,RES,OEM,PG, Medline SKU 80084017.

0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.

0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.

Lack of Assurance of Sterility

0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.

0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.

Lack of Assurance of Sterility

Teva Pharmaceuticals USA, Inc

Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).

Apr 15, 2026Teva Pharmaceuticals USA, Inc

Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).

Superpotent and Subpotent

Pure Vitamins and Natural Supplements, LLC

Boner Bears Honey Male Enhancement 100% Wildflower Honey, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume 1 entire pouch 30 minutes before Intercourse. MANUFACTURED IN: FLORIDA. UPC 788362191603

FDA FoodClass I

Boner Bears Honey Male Enhancement 100% Wildflower Honey, total of 15 pouches per box, Net Wt 15 G each pouch. Dosage: Consume 1 entire pouch 30 minutes before Intercourse. MANUFACTURED IN: FLORIDA. UPC 788362191603

FDA analysis revealed the presence of undeclared sildenafil and Tadalafil

Apr 15, 2026Pure Vitamins and Natural Supplements, LLC

Zarlengo's Chocolate Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups and 1-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and round Polyethylene terephthalate cup with peelable paper lid, laminated with heat-sealable plastic, 16 fl oz cups and 32 fl oz cups translucent freezer grade and round High-Density Polyethylene container with lid and 1 Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid.

Zarlengo Italian Ice

Apr 15, 2026Zarlengo Italian Ice

Zarlengo's Chocolate Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups and 1-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and round Polyethylene terephthalate cup with peelable paper lid, laminated with heat-sealable plastic, 16 fl oz cups and 32 fl oz cups translucent freezer grade and round High-Density Polyethylene container with lid and 1 Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid.

Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.

Connecticut Crab Company LLC

Crab Cakes various sizes sold to food service

Apr 15, 2026Connecticut Crab Company LLC

Crab Cakes various sizes sold to food service

May be temperature abused, which may result in growth of Clostridium botulinum

5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.

5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.

Lack of Assurance of Sterility

Apr 15, 2026Medline Industries, LP

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B

Medline Industries, LP

FDA DevicesClass I

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B

Apr 15, 2026Cook Incorporated

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

Cook Incorporated

FDA DevicesClass II

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91

Viatris, Inc.

Apr 15, 2026Viatris, Inc.

Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91

Failed Dissolution Specifications

Apr 15, 2026Cook Incorporated

COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.

Cook Incorporated

FDA DevicesClass II

COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

GE Healthcare Ireland Limited

GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.