Class IIMedicationMay 1, 2026
Safecor Health, LLC: Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by:…
Presence of a Foreign Substance; black particles observed in liquid
Product, lots & distribution
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08 — Distribution: OH — Lots/codes: Lot, expiry: Lots 26110722, 26110743, exp 9/8/2026; Lot 26111218, exp 9/9/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 1, 2026
Ocinet, Inc.: ...And Kimchi branded kimchi; packaged in 3 sizes of glass containers (126oz, 63oz, 30oz); 126oz UPC- 8541200408 62oz UPC- 8651200409 30oz UPC- 8541200411
Undeclared allergen ingredient (fish)
Product, lots & distribution
...And Kimchi branded kimchi; packaged in 3 sizes of glass containers (126oz, 63oz, 30oz); 126oz UPC- 8541200408 62oz UPC- 8651200409 30oz UPC- 8541200411 — Distribution: Product was distributed to locations in California, Texas and Georgia. — Lots/codes: No lot numbers provided. Recall includes all product. — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMay 1, 2026
SECOND NATURE BRAND: SECOND NATURE KETO CRUNCH SMART MIX, 10-ounce retail-sized plastic pouch, UPC 077034013405, 6-10oz units per case.
The product may contain undeclared allergens (cashews, pistachios), and dried cherries.
Product, lots & distribution
SECOND NATURE KETO CRUNCH SMART MIX, 10-ounce retail-sized plastic pouch, UPC 077034013405, 6-10oz units per case. — Distribution: Distributed nationwide in retail stores and through online orders. — Lots/codes: Best if Used By: 2/12/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 30, 2026
Safecor Health, LLC: Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Product, lots & distribution
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01 — Distribution: TX only — Lots/codes: Lot #: 25530722 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 29, 2026
Ajanta Pharma Ltd.: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Ph…
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Product, lots & distribution
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India — Distribution: Nationwide within U.S — Lots/codes: Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 29, 2026
Ajanta Pharma Ltd.: Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Product, lots & distribution
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03 — Distribution: Nationwide within U.S — Lots/codes: Lot#: PA07434, Exp. May 2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 29, 2026
Ajanta Pharma Ltd.: Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Product, lots & distribution
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06. — Distribution: Nationwide within U.S — Lots/codes: Lot#: PA10734, Exp. Jun 2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 29, 2026
Zydus Pharmaceuticals (USA) Inc: Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (…
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Product, lots & distribution
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1). — Distribution: Nationwide within the U.S — Lots/codes: Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 29, 2026
Zydus Pharmaceuticals (USA) Inc: Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (…
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Product, lots & distribution
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3). — Distribution: Nationwide within the U.S — Lots/codes: Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 28, 2026
Prospector Popcorn, LLC: Prospector Popcorn brand Belgian Chocolate Toffee flavored popcorn; Ingredients: Non-GMO popcorn, brown sugar, corn syrup, butter, vanilla, baking soda, sea salt, white choco…
Products contain undeclared soy, specifically soy lecithin.
Product, lots & distribution
Prospector Popcorn brand Belgian Chocolate Toffee flavored popcorn; Ingredients: Non-GMO popcorn, brown sugar, corn syrup, butter, vanilla, baking soda, sea salt, white chocolate (sugar, palm kernel fat, skimmed milk powder [12%], emulsifier [lecithins], natural vanilla flavoring), dark chocolate (sugar, palm kernel fat, fat reduced cocoa powder [20%], emulsifiers [lecithins], natural vanilla flavoring), pretzels (flour, water, salt, malt, dextrose, canola oil, yeast, soda), tofee bits (sugar, butter, almonds), coarse sea salt.; CONTAINS: MILK, TREE NUTS (ALMONDS), WHEAT; Produced in a facility that is shared with gluten, nuts, dairy, and soy.; Manufactured by: Prospector Popcord, LLC, Ridgefield, CT 06877; UPC: 850073852125 — Distribution: CT and NY — Lots/codes: Expiration dates August 5 - October 24, 2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 27, 2026
Oasis Medical, Inc.: Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made…
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Product, lots & distribution
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1. — Distribution: Nationwide within the United States — Lots/codes: Lot # 1V59, Exp Date: 05/31/26; Lot # 3V12, 3V69, Exp Date: 08/31/26. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 27, 2026
Ascend Laboratories, LLC: Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laborat…
Failed Dissolution Specifications
Product, lots & distribution
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01. — Distribution: U.S. Nationwide — Lots/codes: Lot # 25140859; Exp. Date: Jan 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 27, 2026
The Brownie Baker Inc.: cafe nouria blueberry muffin NET WT. 6 OZ (170g) UPC: 811070033986
Undeclared walnuts
Product, lots & distribution
cafe nouria blueberry muffin NET WT. 6 OZ (170g) UPC: 811070033986 — Distribution: U.S. Distribution: IL Foreign Distribution: Not Applicable — Lots/codes: Lot: 6082 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 27, 2026
Chocolate Bar Holdings LLC: Winfield's CWB Chocolate Bar, packed in clear cello bag with fabric bow on top. Manufactured by CBSL Commissary (DBA Winfield's Chocolate Bar) 9127 Stella Link Rd Houston…
Undeclared milk allergen.
Product, lots & distribution
Winfield's CWB Chocolate Bar, packed in clear cello bag with fabric bow on top. Manufactured by CBSL Commissary (DBA Winfield's Chocolate Bar) 9127 Stella Link Rd Houston Texas. Multiple product shapes/sizes: 1) Cat, Net wt. 8oz (226.8g), UPC: 00810079833030, Unit size 5 x 3 1/2 x 2. 2) Teddy Bear, Net wt. 8oz (226.8g), UPC: 00810079833405, Unit size 5 1/2 x 2 1/2 x 2. 3) Easter Bunny, Net wt. 16oz (453.59g), UPC: 00810079837892, Unit size 4 x 1 x 8 1/2. — Distribution: Houston, TX — Lots/codes: No lot numbers are on these products, so the firm's recall scope is for the entire production line for the following product numbers: 00810079833030 00810079833405 00810079837892 — Status: Completed (voluntary: firm initiated)
Class IIMedicationApr 24, 2026
Teva Pharmaceuticals USA, Inc: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe co…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Product, lots & distribution
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21. — Distribution: Nationwide in the USA — Lots/codes: Lot: 45011002, Exp. 03/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 24, 2026
Lupin Pharmaceuticals Inc.: Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA…
Presence of particulate matter: a white thread-like structure in the cartridge
Product, lots & distribution
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03. — Distribution: Nationwide within U.S — Lots/codes: Lots: a) WB00097, WB00094, WB00088, Expires: Jul. 2027; WB00103, Expires: Oct. 2027; WC00016, Expires: Dec. 2027; b) WB00098, WB00092, WB00093, Expires: Jul. 2027; WB00104, WB00106, WB00105, Expires: Oct. 2027. — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 24, 2026
Target Corporation: Good & Gather Fresh from Our Deli. Sesame Teriyaki Chicken with Rice. Net Wt 18.0 oz (1.125lb). Keep Refrigerated. DPCI # 878-02-0227. UPC (01) 00250086000009 (3922) 00999. Distri…
Undeclared allergens (sesame and soy)
Product, lots & distribution
Good & Gather Fresh from Our Deli. Sesame Teriyaki Chicken with Rice. Net Wt 18.0 oz (1.125lb). Keep Refrigerated. DPCI # 878-02-0227. UPC (01) 00250086000009 (3922) 00999. Distributed by SuperTarget Mpls, MN 55403. — Distribution: AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MN, MO, NC, ND, NE, OK, TN, TX, UT, VA, WI — Lots/codes: Use or Freeze By: 4/15/26 through 4/27/26 — Status: Terminated (voluntary: firm initiated)
Class IIMedicationApr 23, 2026
Thea Pharma, Inc.: iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Product, lots & distribution
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11 — Distribution: Nationwide within the United States — Lots/codes: Lot#: 3T36B, Exp. Date October 31, 2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 23, 2026
Thea Pharma, Inc.: Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Product, lots & distribution
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11 — Distribution: Nationwide within the United States — Lots/codes: Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 23, 2026
JB Chemicals and Pharmaceuticals Ltd: Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceutica…
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Product, lots & distribution
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10. — Distribution: Nationwide in the USA — Lots/codes: Lot #: GEH25023, Expires: 6/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
King Juice Company, Inc.: Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UPC 0 79581-18709 7. Keep Refrigerated After Opening. King Juice Company, Inc., Milwaukee, Wisconsin 53221.
Product contains undeclared Yellow No. 5.
Product, lots & distribution
Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UPC 0 79581-18709 7. Keep Refrigerated After Opening. King Juice Company, Inc., Milwaukee, Wisconsin 53221. — Distribution: Nationwide. Outside the US to Australia, New Zealand, Singapore, and Trinidad and Tobago — Lots/codes: All Lot Codes including and prior to 01APR2027 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: Joint Nourish. Dosage:2 tablespoons (30mL). Liquid. For Oral use. Packaging: Plastic Bottle. Net Volume:480 ml. Firm Address: VitaminAlly LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen contamination and possible C. Botulinum concerns.
Product, lots & distribution
Joint Nourish. Dosage:2 tablespoons (30mL). Liquid. For Oral use. Packaging: Plastic Bottle. Net Volume:480 ml. Firm Address: VitaminAlly LLC Chandler, AZ 85225. — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution dates: 10/01/2025-04/08/2026 Lot Number JN0925 Expiry Date 09/2027 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: FulviLife Complex. Dosage:2 tablespoons (30mL). Liquid. Packaging: Plastic Bottle. Net Volume:16 fl oz (480 ml). Firm Address: VitaminAlly LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Product, lots & distribution
FulviLife Complex. Dosage:2 tablespoons (30mL). Liquid. Packaging: Plastic Bottle. Net Volume:16 fl oz (480 ml). Firm Address: VitaminAlly LLC Chandler, AZ 85225. — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution dates: 10/01/2024-04/08/2026 Lot Number: FL1024 Expiry Date: 10/2026 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: Liposomal Womens 50+ Liquid Multivitamin Drops. Dosage: 3ml Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Product, lots & distribution
Liposomal Womens 50+ Liquid Multivitamin Drops. Dosage: 3ml Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225. — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution dates: 10/01/2024-04/08/2026 Lot Number: W+0925 Expiry Date: 09/2027 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: Liposomal Mens Liquid Multivitamin Drops. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Product, lots & distribution
Liposomal Mens Liquid Multivitamin Drops. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225. — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution dates: 10/01/2024-04/08/2026 Lot Number MM0925 Expiry Date 09/2027 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: Liposomal Mens 50+ Liquid Multivitamin Drops. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Product, lots & distribution
Liposomal Mens 50+ Liquid Multivitamin Drops. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225. — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution dates: 06/01/2025-04/08/2026 Lot Number M+0625 Expiry Date 06/2027 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: Liposomal Women's Liquid Multivitamin Drops with Iron. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Product, lots & distribution
Liposomal Women's Liquid Multivitamin Drops with Iron. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225. — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution dates: 06/01/2025-04/08/2026 Lot Number WM0625 Expiry Date 06/2027 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: Liposomal Collagen Booster. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Product, lots & distribution
Liposomal Collagen Booster. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225. — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution Dates: 06/01/2025-04/08/2026 Lot Number CB0625 Expiry Date 06/2027 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: Liposomal Kids Liquid Multivitamin Drops. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Product, lots & distribution
Liposomal Kids Liquid Multivitamin Drops. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225 — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution Dates: 06/01/2025-04/08/2026 Lot Number KM0625 Expiry Date 06/2027 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: Liposomal Women's Liquid Multivitamin Drops - Iron Free. Dosage: 3ml Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Product, lots & distribution
Liposomal Women's Liquid Multivitamin Drops - Iron Free. Dosage: 3ml Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225. — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution Dates: 10/01/2024-04/08/2026 Lot Number:WN0924 Expiry Date:09/2026 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: Liposomal Prenatal+Postnatal Liquid Multivitamin Drops - Iron Free. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Product, lots & distribution
Liposomal Prenatal+Postnatal Liquid Multivitamin Drops - Iron Free. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225 — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution Dates: 09/01/2024-04/08/2026 Lot Number PN0824 Expiry Date 08/2026 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: Liposomal D3-5000IU Spray Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Product, lots & distribution
Liposomal D3-5000IU Spray Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225. — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution Dates: 10/01/2024-04/08/2026 Lot Number DS1024 Expiry Date 10/2026 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: Liposomal D3+B12 Spray. Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm Address: VitaminAlly LLC Chandler, AZ 85225.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Product, lots & distribution
Liposomal D3+B12 Spray. Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm Address: VitaminAlly LLC Chandler, AZ 85225. — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution Dates: 10/01/2024-04/08/2026 Lot Number DB1024 Expiry Date 10/2026 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: Liposomal B12 Spray. Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm Address: VitaminAlly LLC Chandler, AZ 85225
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Product, lots & distribution
Liposomal B12 Spray. Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm Address: VitaminAlly LLC Chandler, AZ 85225 — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution Dates: 10/01/2024-04/08/2026 Lot Number MB1024 Expiry Date 10/2026 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Wellnov Supplements LLC: Liposomal Sleep Spray. Dosage: 6 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm Address: VitaminAlly LLC Chandler, AZ 85225
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.
Product, lots & distribution
Liposomal Sleep Spray. Dosage: 6 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm Address: VitaminAlly LLC Chandler, AZ 85225 — Distribution: Products were distributed nationwide and the United States Territory of Puerto Rico. — Lots/codes: Distribution Dates: 10/01/2025-04/08/2026 Lot Number SL0925 Expiry Date 09/2027 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Mango Lassi 16 oz., 64 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Mango Lassi 16 oz., 64 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 16 oz. UPC: 68061710002 64 oz. UPC: 68061710018 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Rose Lassi 16 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Rose Lassi 16 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 UPC:68061710005 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Sweet Lassi 16 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Sweet Lassi 16 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 UPC: 68061710006 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Salty Lassi 16 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Salty Lassi 16 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 UPC: 68061710010 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Pineapple Lassi 16 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Pineapple Lassi 16 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 UPC: 68061710004 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Strawberry Lassi 16 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Strawberry Lassi 16 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 UPC: 68061710007 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Mango-Pina-Strawberry Lassi 16 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Mango-Pina-Strawberry Lassi 16 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 UPC: 68061710009 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Mango-Pina-Orange Lassi 16 oz., 64 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Mango-Pina-Orange Lassi 16 oz., 64 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 16 oz. UPC: 68061710008 64 oz. UPC: 68061710008 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Plain Chaash Lassi 16 oz., 64 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Plain Chaash Lassi 16 oz., 64 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 64 oz UPC: 68061710050 16 oz. UPC: 68061710021 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Masala Chaash Lassi 16 oz., 64 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Masala Chaash Lassi 16 oz., 64 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 16 oz. UPC Codes: 68061710012 64 oz. UPC code: 68061710014 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Mint Lassi 16 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Mint Lassi 16 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 UPC Codes:68061710060 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Peach Lassi 16 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Peach Lassi 16 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 UPC Codes:68061710001 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Orange Lassi 16 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Orange Lassi 16 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 UPC: 68061710033 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 23, 2026
Joy Gourmet Foods LLC.: Joy Saffron Cardamon Lassi 16 oz.
Product not adequately pasteurized
Product, lots & distribution
Joy Saffron Cardamon Lassi 16 oz. — Distribution: NY, NJ, PA — Lots/codes: Expiry June 30 through July 30, 2026 68061710034 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 22, 2026
CareFusion 213, LLC: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 7…
Lack of assurance of Sterility: potential product contamination
Product, lots & distribution
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42. — Distribution: Nationwide in the USA — Lots/codes: Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp. — Status: Ongoing (voluntary: firm initiated)