Class IIFoodApr 15, 2026
Silver Moon LP dba Loard's Ice Cream: Loard's Rocky Road Ice Cream - 56 oz
Undeclared Milk, Walnuts, Eggs.
Product, lots & distribution
Loard's Rocky Road Ice Cream - 56 oz — Distribution: Loard's brand distributed to Loard's Ice Cream parlors located in Northern California. Private labels distributed to grocery stores located in Northern California. — Lots/codes: None — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 15, 2026
Silver Moon LP dba Loard's Ice Cream: Loard's Sea Salt Caramel Ice Cream - 32 oz
Undeclared Milk, Soy, Sulfites.
Product, lots & distribution
Loard's Sea Salt Caramel Ice Cream - 32 oz — Distribution: Loard's brand distributed to Loard's Ice Cream parlors located in Northern California. Private labels distributed to grocery stores located in Northern California. — Lots/codes: None — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 15, 2026
Silver Moon LP dba Loard's Ice Cream: Loard's Strawberry Ice Cream - 32 oz; 56 oz
Undeclared Milk, Red #40.
Product, lots & distribution
Loard's Strawberry Ice Cream - 32 oz; 56 oz — Distribution: Loard's brand distributed to Loard's Ice Cream parlors located in Northern California. Private labels distributed to grocery stores located in Northern California. — Lots/codes: None — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 15, 2026
Silver Moon LP dba Loard's Ice Cream: Loard's Toasted Almond Ice Cream - 32 oz
Undeclared Milk, Almonds.
Product, lots & distribution
Loard's Toasted Almond Ice Cream - 32 oz — Distribution: Loard's brand distributed to Loard's Ice Cream parlors located in Northern California. Private labels distributed to grocery stores located in Northern California. — Lots/codes: None — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 15, 2026
Silver Moon LP dba Loard's Ice Cream: Loard's Ube Ice Cream - 32 oz
Undeclared Milk, Red #3, Red #40, Blue #1, Blue #2.
Product, lots & distribution
Loard's Ube Ice Cream - 32 oz — Distribution: Loard's brand distributed to Loard's Ice Cream parlors located in Northern California. Private labels distributed to grocery stores located in Northern California. — Lots/codes: None — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 15, 2026
Silver Moon LP dba Loard's Ice Cream: Loard's Vanilla Ice Cream - 32 oz; 56 oz
Undeclared Milk.
Product, lots & distribution
Loard's Vanilla Ice Cream - 32 oz; 56 oz — Distribution: Loard's brand distributed to Loard's Ice Cream parlors located in Northern California. Private labels distributed to grocery stores located in Northern California. — Lots/codes: None — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 15, 2026
Silver Moon LP dba Loard's Ice Cream: Banana Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00903
Undeclared Yellow #5
Product, lots & distribution
Banana Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00903 — Distribution: Loard's brand distributed to Loard's Ice Cream parlors located in Northern California. Private labels distributed to grocery stores located in Northern California. — Lots/codes: UPC: 8-12017-00903 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 15, 2026
Silver Moon LP dba Loard's Ice Cream: Chocolate Mint Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00917
Undeclared Soy (with mitigating circumstances), Yellow #5, Blue #1
Product, lots & distribution
Chocolate Mint Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00917 — Distribution: Loard's brand distributed to Loard's Ice Cream parlors located in Northern California. Private labels distributed to grocery stores located in Northern California. — Lots/codes: UPC: 8-12017-00917 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 15, 2026
Silver Moon LP dba Loard's Ice Cream: Chocolate Showers Ice Cream - 32 oz (5 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods, and Berkeley Bowl) UPC: 8-12017-00918
Undeclared Soy (with mitigating circumstances)
Product, lots & distribution
Chocolate Showers Ice Cream - 32 oz (5 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods, and Berkeley Bowl) UPC: 8-12017-00918 — Distribution: Loard's brand distributed to Loard's Ice Cream parlors located in Northern California. Private labels distributed to grocery stores located in Northern California. — Lots/codes: UPC: 8-12017-00918 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 14, 2026
LACTALIS CANADA, INC: Specially SELECTED brand Vanilla Creme Brulee; NET WT 3.6oz (103g); INGREDIENTS: CREAM (MILK, CREAM), FROZEN YOLK MIX (EGG YOLK, SUGAR) SUGAR, NATURAL VANILLA FLAVOR, TAPIOCA ST…
Product may contain foreign objects, specifically glass.
Product, lots & distribution
Specially SELECTED brand Vanilla Creme Brulee; NET WT 3.6oz (103g); INGREDIENTS: CREAM (MILK, CREAM), FROZEN YOLK MIX (EGG YOLK, SUGAR) SUGAR, NATURAL VANILLA FLAVOR, TAPIOCA STARCH, CARRAGEENAN; TOPPING INGREDIENTS: CARAMEL FLAKES (SUGAR, GLUCOSE SYRUP); CONTAINS: MILK, EGGS. MAY CONTAIN: WHEAT, SOY; DIST.SOLD EXCLUSIVELY BY: ALDI BATAVIA, IL; packaged in glass jars — Distribution: NY, IN, FL, IL, VA, MD, and MI — Lots/codes: Best Before/Use By Date: 5/9/2026 Product Number: 710298-4099100342826 Barcode: 4099100342826 — Status: Terminated (voluntary: firm initiated)
Class IIFoodApr 13, 2026
Guangdong Zonegoing Food Co., LTD: 52USA brand POPPING BOBA; STRAWBERRY FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E14…
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
Product, lots & distribution
52USA brand POPPING BOBA; STRAWBERRY FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), sucralose (E955), allura red (E129), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 10185 42123 7 — Distribution: NY — Lots/codes: Lot Numbers: 20250813 Expiration Date: Feb 8, 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 13, 2026
Guangdong Zonegoing Food Co., LTD: 52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (…
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
Product, lots & distribution
52USA brand POPPING BOBA; PASSION FRUIT FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42125 1 — Distribution: NY — Lots/codes: Lot Numbers: 20250813 Expiration Date: Feb 8, 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 13, 2026
Guangdong Zonegoing Food Co., LTD: 52USA brand POPPING BOBA; MANGO FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442),…
Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).
Product, lots & distribution
52USA brand POPPING BOBA; MANGO FLAVOR; Net wt: 7 lb (3.2kg); Ingredients Drinking water, fructose syrup, food additives (hydroxypropyl distarch phosphate (E1442), calcium lactate (E327), DL-malic acid (E296), sodium alginate (E401), citric acid (E330), carrageenan (EE407), potassium chloride (E508), potassium sorbate (E202), guar gum (E412), trisodium citrate (E331), beta-carotene (E160a). sucralose (E955), tartrazine (E102), sunset yellow (E110)), food flavors.; CONTAINS NO JUICE; Shelf Life: 18 months; Distributed for Felicific Inc., Queens, NY 11435; PRODUCT OF CHINA; UPC 8 1018 42124 4 — Distribution: NY — Lots/codes: Lot Numbers: 20250813 Expiration Date: Feb 8, 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 13, 2026
Raja Foods and Vegetables Inc.: Swad Orange Flavored Masala Candy
Contains undeclared FD&C Yellow 6
Product, lots & distribution
Swad Orange Flavored Masala Candy — Distribution: NY, NJ, DE, MA, PA, MD, CT, CA, NH, VT, — Lots/codes: Lot: RF CA25233 UPC Codes: 5117939577 Use by: FEBRUARY 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 13, 2026
Raja Foods and Vegetables Inc.: Swad Mango Flavored Masala Candy
Contains undeclared Blue 1
Product, lots & distribution
Swad Mango Flavored Masala Candy — Distribution: NY, NJ, DE, MA, PA, MD, CT, CA, NH, VT, — Lots/codes: Lot: RF CA25301 UPC: 5117939557 Use by: APRIL 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 9, 2026
The Harvard Drug Group LLC: Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, In…
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Product, lots & distribution
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06 — Distribution: Nationwide in the USA — Lots/codes: Lot#: Lot N02406, Exp 10/31/2026; Lot N02845, Exp 12/31/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Apotex Corp.: Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505…
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Product, lots & distribution
Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0 — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: VM4231, Exp 06/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78…
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Product, lots & distribution
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01. — Distribution: Nationwide in the USA — Lots/codes: Lot #: BL3435, Exp. 11/06/26 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Product, lots & distribution
TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01. — Distribution: Nationwide in the USA — Lots/codes: Lot #BL3411R, Exp 6/8/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01.
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Product, lots & distribution
TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01. — Distribution: Nationwide in the USA — Lots/codes: Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Product, lots & distribution
vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2. — Distribution: Nationwide in the USA — Lots/codes: Lot BL3462, Exp. 2/7/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Product, lots & distribution
TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01 — Distribution: Nationwide in the USA — Lots/codes: Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal…
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Product, lots & distribution
Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid). Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc — Distribution: Nationwide in the USA — Lots/codes: Lot BL3572, Exp 04/16/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 8, 2026
Blaine Labs Inc: Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, w…
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Product, lots & distribution
Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670, — Distribution: Nationwide in the USA — Lots/codes: Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 7, 2026
Hikma Pharmaceuticals USA INC: Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC…
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Product, lots & distribution
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59. — Distribution: US Nationwide. — Lots/codes: Lot # AC2040A, Exp Date: 04/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 7, 2026
Marquez Brothers International, Inc.: Bulk Horchata Powder 3951 (100547) 1/25 HORCHATA UPC: 042743-19015-0 Item: 100547
Undeclared milk.
Product, lots & distribution
Bulk Horchata Powder 3951 (100547) 1/25 HORCHATA UPC: 042743-19015-0 Item: 100547 — Distribution: Domestic distribution: AK, AL, AR, AZ, CA, CO, FL, IA, ID, IL, IN, KS, LA, MI, MN, MO, MT, NE, NM, NV, OH, OK, OR, TN, TX, UT, VA, WA, WI. Foreign distribution: Canada, Japan. — Lots/codes: Lot, Expiration: HR02224, 01/23/26; HR06124, 03/05/26; HR16524, 06/14/26; HR23624, 08/27/26; HR34124, 12/11/26; HR07125, 03/13/27; HR09025, 04/03/27; HR23425, 08/27/27; HR34425, 12/15/27; HR01926, 01/28/28. — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 7, 2026
Marquez Brothers International, Inc.: EL MEXICANO horchata casera Instant Horchata Drink NET WT 14oz (396g) INGREDIENTS: *** MILK SUBSTITUTE (WHEY *** LACTOSE *** DISTRIBUTED BY MARQUEZ BROTHERS INTE…
Undeclared milk.
Product, lots & distribution
EL MEXICANO horchata casera Instant Horchata Drink NET WT 14oz (396g) INGREDIENTS: *** MILK SUBSTITUTE (WHEY *** LACTOSE *** DISTRIBUTED BY MARQUEZ BROTHERS INTERNATIONAL, INC. San Jose CA 95138 UPC: 042743190266 Item: 102284 — Distribution: Domestic distribution: AK, AL, AR, AZ, CA, CO, FL, IA, ID, IL, IN, KS, LA, MI, MN, MO, MT, NE, NM, NV, OH, OK, OR, TN, TX, UT, VA, WA, WI. Foreign distribution: Canada, Japan. — Lots/codes: Lot, Expiration: HC10124, 04/11/26; HC16524, 06/14/26; HC21324, 08/01/26; HC29924, 10/28/26; HC06625, 03/06/27; HC06625, 03/07/27; HC16325, 06/13/27; HC19525, 07/15/27; HC28325, 10/13/27; HC28325, 10/14/27. — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 7, 2026
Marquez Brothers International, Inc.: EL MEXICANO agua fresca de horchata Instant Horchata Drink NET WT 12oz (340g) INGREDIENTS: *** MILK SUBSTITUTE (WHEY *** LACTOSE *** DISTRIBUTED BY MARQUEZ BROTH…
Undeclared milk.
Product, lots & distribution
EL MEXICANO agua fresca de horchata Instant Horchata Drink NET WT 12oz (340g) INGREDIENTS: *** MILK SUBSTITUTE (WHEY *** LACTOSE *** DISTRIBUTED BY MARQUEZ BROTHERS INTERNATIONAL, INC. San Jose CA 95138 UPC: 042743190204 Item: 102279 — Distribution: Domestic distribution: AK, AL, AR, AZ, CA, CO, FL, IA, ID, IL, IN, KS, LA, MI, MN, MO, MT, NE, NM, NV, OH, OK, OR, TN, TX, UT, VA, WA, WI. Foreign distribution: Canada, Japan. — Lots/codes: Lot, Expiration: HR02324, 01/26/26; HR02324, 01/29/26; HR06424, 03/07/26; HR09924, 04/09/26; HR10024, 04/10/26; HR12924, 05/09/26; HR13024, 05/13/26; HR13024, 05/14/26; HR16424, 06/13/26; HR17824, 06/27/26; HR17824, 06/28/26; HR21124, 07/30/26; HR21224, 07/31/26; HR23524, 08/26/26; HR23624, 08/27/26; HR26724, 09/25/26; HR29724, 10/24/26; HR29824, 10/25/26; HR29924, 11/19/26; HR32424, 11/20/26; HR02225, 01/23/27; HR02225, 01/24/27; HR05825, 03/05/27; HR05925, 03/06/27; HR08625, 03/28/27; HR08625, 03/31/27; HR08725, 04/01/27; HR15725, 06/09/27; HR16025, 06/10/27; HR16225, 06/12/27; HR16325, 06/… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 6, 2026
Fresenius Medical Care Holdings, Inc.: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-…
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Product, lots & distribution
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451. — Distribution: Nationwide in the USA — Lots/codes: Lot #: 25CU02007, 25CU02008, 25CU02009 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 6, 2026
Fresenius Medical Care Holdings, Inc.: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-…
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Product, lots & distribution
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451. — Distribution: Nationwide in the USA — Lots/codes: Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 6, 2026
Teva Pharmaceuticals USA, Inc: Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-…
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Product, lots & distribution
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. — Distribution: Nationwide in the USA, Puerto Rico and Virgin Islands — Lots/codes: Lots#: 100067507, 100067508, Exp 07/31/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 6, 2026
LIQUID BLENZ CORP: Liquid Blenz Soursop Bitters 16 oz and 32 oz.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Product, lots & distribution
Liquid Blenz Soursop Bitters 16 oz and 32 oz. — Distribution: NY and online sales — Lots/codes: 16 oz with upc: 860005735006 & 32 oz with upc: 860005735013 Lots: SS75223, SS00669, SS95811, SS95114, SS11139, SS54495, SS81258, SS44886 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 6, 2026
LIQUID BLENZ CORP: Blackseed Bitters 16 oz and 32 oz.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Product, lots & distribution
Blackseed Bitters 16 oz and 32 oz. — Distribution: NY and online sales — Lots/codes: 16 oz. with upc: 860005735020 & 32 oz with upc: 860005735037 Lots: BS62367, BS25400, BS11595, BS75444, BS75721, BS90605, BS34888 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 6, 2026
LIQUID BLENZ CORP: Sea Moss Tonic 16 oz and 32. oz.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Product, lots & distribution
Sea Moss Tonic 16 oz and 32. oz. — Distribution: NY and online sales — Lots/codes: 16 oz with upc: 196852654833 & 32 oz with upc: 196852456406 Lots: not provided — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 6, 2026
LIQUID BLENZ CORP: Pure Diabetes Bully 16 oz and 32 oz.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Product, lots & distribution
Pure Diabetes Bully 16 oz and 32 oz. — Distribution: NY and online sales — Lots/codes: 16 oz with upc: 195893374878 & 32 oz with upc: 195893984466 Lots: DB58525, DB58885, DB21000, DB58661, DB25909, DB09550, DB66236, DB52855 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 6, 2026
LIQUID BLENZ CORP: Pure Libido Drink 16 oz and 32 oz.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Product, lots & distribution
Pure Libido Drink 16 oz and 32 oz. — Distribution: NY and online sales — Lots/codes: 16 oz with upc: 195893463176 & 32 oz with upc: 195893949991 Lots: LB08560, LB18863, LB76882, LB84633, LB55881 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 6, 2026
LIQUID BLENZ CORP: Immunity Enhancer Elderberry 16 oz and 32 oz.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Product, lots & distribution
Immunity Enhancer Elderberry 16 oz and 32 oz. — Distribution: NY and online sales — Lots/codes: 16 oz with upc: 860005735099 & 32 oz with upc: 195893965434 Lots: not provided — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 6, 2026
LIQUID BLENZ CORP: Menopause Bully 16 oz and 32 oz.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Product, lots & distribution
Menopause Bully 16 oz and 32 oz. — Distribution: NY and online sales — Lots/codes: 16oz with upc: 860010984420 & 32oz with upc: 860010984437 Lots: not provided — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 6, 2026
LIQUID BLENZ CORP: Fibroid Bully 16 oz and 32 oz.
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Product, lots & distribution
Fibroid Bully 16 oz and 32 oz. — Distribution: NY and online sales — Lots/codes: 16 oz with upc: 860010984406 & 32 oz with upc: 860010984413 Lots: not provided — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 6, 2026
LIQUID BLENZ CORP: Prostate Bully 16 oz and 32 oz
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Product, lots & distribution
Prostate Bully 16 oz and 32 oz — Distribution: NY and online sales — Lots/codes: 16 oz with upc: 860010984444 & 32 oz with upc: 860010984451 Lots: PB11333, PB29969, PB57444, PB00880, PB48552; — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 6, 2026
LIQUID BLENZ CORP: Pure Shilajit Tonic 16 oz and 32 oz
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Product, lots & distribution
Pure Shilajit Tonic 16 oz and 32 oz — Distribution: NY and online sales — Lots/codes: 16 oz with upc: 860010984482 & 32 oz with upc: 860010984499 Lots: not provided — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 6, 2026
LIQUID BLENZ CORP: Blood Pressure Bully 16 oz and 32 oz
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Product, lots & distribution
Blood Pressure Bully 16 oz and 32 oz — Distribution: NY and online sales — Lots/codes: 16 oz with upc: 196852985432 & 32 oz with upc: 196852553129 Lots: BP02581, BP83283, BP14888, BP95123, BP75660 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 6, 2026
LIQUID BLENZ CORP: Flat Belly Bully 16 oz and 32 oz
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Product, lots & distribution
Flat Belly Bully 16 oz and 32 oz — Distribution: NY and online sales — Lots/codes: 16 oz with upc: 196852337118 & 32 oz with upc: 196852926770 Lots: : FBB5552, FBB6226, FBB8166, FBB8536, FBB7757, FBB5277 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 6, 2026
LIQUID BLENZ CORP: Liquid Blenz Good Brain Tonic 16 oz and 32 oz
May be under-processed resulting in growth of Clostridium botulinum and lists health claims.
Product, lots & distribution
Liquid Blenz Good Brain Tonic 16 oz and 32 oz — Distribution: NY and online sales — Lots/codes: 16 oz with UPC: 860010984468 & 32 oz with UPC: 860010984475 Lots: not provided — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 4, 2026
Dakota Honey Company: Dakota Honey Company Spreadable Spun Honey, Original. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60010-57…
Foreign object (stainless steel dust/flakes or shreds of plastic)
Product, lots & distribution
Dakota Honey Company Spreadable Spun Honey, Original. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60010-57969 5. 2. Net Wt 12 oz (340g) UPC 8 60010-57961 9. — Distribution: Retail locations in FL, GA, and SD Internet sales Nationwide — Lots/codes: Honey does not have any code on container. 1. 4 oz spun honey purchased from December 19, 2025 to April 3, 2026 2. 12 oz spun honey purchased from February 25, 2026 to April 3, 2026 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 4, 2026
Dakota Honey Company: Dakota Honey Company Spreadable Spun Honey, Cinnamon-Infused. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8…
Foreign object (stainless steel dust/flakes or shreds of plastic)
Product, lots & distribution
Dakota Honey Company Spreadable Spun Honey, Cinnamon-Infused. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60012-41980 7. 2. Net Wt 12 oz (340g) UPC 8 60010-57963 3. — Distribution: Retail locations in FL, GA, and SD Internet sales Nationwide — Lots/codes: Honey does not have any code on container. 1. 4 oz spun honey purchased from December 19, 2025 to April 3, 2026 2. 12 oz spun honey purchased from February 25, 2026 to April 3, 2026 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 4, 2026
Dakota Honey Company: Dakota Honey Company Spreadable Spun Honey, Salted Caramel. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60…
Foreign object (stainless steel dust/flakes or shreds of plastic)
Product, lots & distribution
Dakota Honey Company Spreadable Spun Honey, Salted Caramel. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60012-41981 4. 2. Net Wt 12 oz (340g) UPC 8 60010-57964 0. — Distribution: Retail locations in FL, GA, and SD Internet sales Nationwide — Lots/codes: Honey does not have any code on container. 1. 4 oz spun honey purchased from December 19, 2025 to April 3, 2026 2. 12 oz spun honey purchased from February 25, 2026 to April 3, 2026 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 4, 2026
Dakota Honey Company: Dakota Honey Company Spreadable Spun Honey, Jalapeno. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60012-41…
Foreign object (stainless steel dust/flakes or shreds of plastic)
Product, lots & distribution
Dakota Honey Company Spreadable Spun Honey, Jalapeno. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60012-41982 1. 2. Net Wt 12 oz (340g) UPC 8 60010-57965 7. — Distribution: Retail locations in FL, GA, and SD Internet sales Nationwide — Lots/codes: Honey does not have any code on container. 1. 4 oz spun honey purchased from December 19, 2025 to April 3, 2026 2. 12 oz spun honey purchased from February 25, 2026 to April 3, 2026 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 4, 2026
Dakota Honey Company: Dakota Honey Company the Honey Flight. 4 Flavors of Spreadable Spun Honey Original - Salted Caramel - Cinnamon - Jalapeno. UPC 8 60010-57968 8. 4 - 4 oz (340g) jars. Net Wt 16 o…
Foreign object (stainless steel dust/flakes or shreds of plastic)
Product, lots & distribution
Dakota Honey Company the Honey Flight. 4 Flavors of Spreadable Spun Honey Original - Salted Caramel - Cinnamon - Jalapeno. UPC 8 60010-57968 8. 4 - 4 oz (340g) jars. Net Wt 16 oz (454g). Produced in Winner, SD. — Distribution: Retail locations in FL, GA, and SD Internet sales Nationwide — Lots/codes: Honey does not have any code on container. 4 oz spun honey Flights purchased from December 19, 2025 to April 3, 2026 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 3, 2026
Walker Honey Co: Fain s Blackberry Honey Spread, 12oz net wt., UPC 01832213862
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
Product, lots & distribution
Fain s Blackberry Honey Spread, 12oz net wt., UPC 01832213862 — Distribution: Texas — Lots/codes: Packed after 12/1/2025 — Status: Ongoing (voluntary: firm initiated)