Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 21292200000 SALMON CAJUN PREMIUM FS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 21292200000 SALMON CAJUN PREMIUM FS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 21136500000 Ready Meals BOWL SALMON TERIYAKI SS COLD UPC 21477800000 Ready Meals BOWL TERIYAKI SALMON LARGE SS COLD UPC 21502100000 Ready Meals MEAL SALMON TERIYAKI SS C…
Contains statement does not declare Salmon
Product, lots & distribution
UPC 21136500000 Ready Meals BOWL SALMON TERIYAKI SS COLD UPC 21477800000 Ready Meals BOWL TERIYAKI SALMON LARGE SS COLD UPC 21502100000 Ready Meals MEAL SALMON TERIYAKI SS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 21494500000 Ready Meals MEAL SALMON With LEMON CAPELLINI PASTA SS This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 21494500000 Ready Meals MEAL SALMON With LEMON CAPELLINI PASTA SS This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 29120700000 Ready Meals SALAD SMOKED SALMON & FETA PASTA SS UPC 29137800000 SALAD SMOKED SALMON & FETA PASTA FS COLD This is Albertson's store-made item and sold by rand…
Contains statement does not declare Salmon
Product, lots & distribution
UPC 29120700000 Ready Meals SALAD SMOKED SALMON & FETA PASTA SS UPC 29137800000 SALAD SMOKED SALMON & FETA PASTA FS COLD This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 21382900000 Ready Meals SALMON PESTO With ASPARAGUS SS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 21382900000 Ready Meals SALMON PESTO With ASPARAGUS SS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 21497700000 Ready Meals SALMON POT ROSETTES & ROSEMARY SS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 21497700000 Ready Meals SALMON POT ROSETTES & ROSEMARY SS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 23098000000 SALMON ATLANTIC PORTION CA ORANGE MARINADE This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 23098000000 SALMON ATLANTIC PORTION CA ORANGE MARINADE This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 23100200000 SALMON ATLANTIC PORTION PIRI PIRI MARINADE This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 23100200000 SALMON ATLANTIC PORTION PIRI PIRI MARINADE This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 23041600000 SALMON COHO FILLET GARLIC HERB SEASONED This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 23041600000 SALMON COHO FILLET GARLIC HERB SEASONED This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 23077600000 SALMON FILLET CARNE ASADA MARINADE This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 23077600000 SALMON FILLET CARNE ASADA MARINADE This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 23090400000 SALMON FILLET POLLO ASADO MARINADE This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 23090400000 SALMON FILLET POLLO ASADO MARINADE This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 23151700000 SALMON FILLET With CITRUS LEMON MARINADE This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 23151700000 SALMON FILLET With CITRUS LEMON MARINADE This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 23180600000 SALMON KABOB With CITRUS LEMON MARINADE This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 23180600000 SALMON KABOB With CITRUS LEMON MARINADE This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 21919300000 SALMON LEMON PEPPER KOSHER PO SS COLD This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 21919300000 SALMON LEMON PEPPER KOSHER PO SS COLD This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 21877300000 SALMON SWEET CHILI KOSHER PO SS COLD This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 21877300000 SALMON SWEET CHILI KOSHER PO SS COLD This is Albertson's store-made item and sold by random weight at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMay 6, 2026
Albertsons Companies LLC: UPC 29604300000 SALMON WASABI GRILLED FS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label.
Contains statement does not declare Salmon
Product, lots & distribution
UPC 29604300000 SALMON WASABI GRILLED FS COLD This is Albertson's store-made item and sold by unit at point of sale with grocery store's scale label. — Distribution: Nationwide. — Lots/codes: Product was labeled with a Packed On date of May 05. 26 or before. — Status: Terminated (voluntary: firm initiated)
Class IIIMedicationMay 4, 2026
Sagent Pharmaceuticals: Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.
Failed Impurities/Degradation Specifications
Product, lots & distribution
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 656412, Exp. Date 08/31/2026; 659646, Exp. Date 03/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMay 1, 2026
Amerisource Health Services LLC: Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton N…
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product, lots & distribution
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11 — Distribution: USA Nationwide — Lots/codes: Lot#: 1027583, Exp 09/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMay 1, 2026
Amerisource Health Services LLC: Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton ND…
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product, lots & distribution
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11 — Distribution: USA Nationwide — Lots/codes: Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 27, 2026
Golden State Medical Supply Inc.: Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-…
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product, lots & distribution
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05 — Distribution: USA Nationwide — Lots/codes: Lot#: GS066750, GS067084, GS067710, GS067873, Exp 3/31/2028; GS068339, GS068897, Exp 8/31/2028 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 27, 2026
Golden State Medical Supply Inc.: Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-63…
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product, lots & distribution
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01 — Distribution: USA Nationwide — Lots/codes: Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 24, 2026
Lannett Company Inc.: Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Product, lots & distribution
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01. — Distribution: USA Nationwide — Lots/codes: Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028. — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 16, 2026
American Regent, Inc.: Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
Labeling: Missing Label
Product, lots & distribution
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01 — Distribution: U.S. Nationwide — Lots/codes: Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIFoodApr 15, 2026
Silver Moon LP dba Loard's Ice Cream: Burgundy Cherry Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00909
Undeclared Red #40, Blue #1, Blue #2
Product, lots & distribution
Burgundy Cherry Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00909 — 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: 8-12017-00909 — Status: Ongoing (voluntary: firm initiated)
Class IIIFoodApr 15, 2026
Silver Moon LP dba Loard's Ice Cream: Peppermint Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00933
Undeclared Red #40
Product, lots & distribution
Peppermint Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00933 — 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: 8-12017-00933 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 14, 2026
Premier Dental Products Co: Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-…
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Product, lots & distribution
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08. — Distribution: Nationwide within the United States — Lots/codes: Lot #: 640911253, Exp Date. 09/14/2027. — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 13, 2026
Unichem Pharmaceuticals USA Inc.: busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India M…
Subpotent drug
Product, lots & distribution
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05. — Distribution: USA Nationwide — Lots/codes: Lot: ZBUL25001, Exp 12/31/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationApr 7, 2026
Water-Jel Technologies, LLC: Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, R…
Failed PH Specifications
Product, lots & distribution
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by: CVS PHarmacy, INc., One CVS Drive, Woonsocket, RI 02895. NDC 59898-950 — Distribution: Nationwide in the USA — Lots/codes: Lots: A5014, A5018, A5019 — Status: Ongoing (voluntary: firm initiated)
Class IIIMedicationMar 31, 2026
Avantor Performance Materials LLC: Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite…
Subpotent drug
Product, lots & distribution
Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-1 — Distribution: Nationwide in the USA, Belgium and France — Lots/codes: Lot 23G3161005, Exp 9/21/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIFoodMar 24, 2026
Tops Markets LLC: Garland Fresh Peeled Garlic 6 oz. bag
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm
Product, lots & distribution
Garland Fresh Peeled Garlic 6 oz. bag — Distribution: NY, VT, PA — Lots/codes: UPC: 00068826753408 UPC: UPC: 00071894000005 Codes: all — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMar 24, 2026
Tops Markets LLC: Christopher Ranch Peeled Garlic 6 oz.
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm
Product, lots & distribution
Christopher Ranch Peeled Garlic 6 oz. — Distribution: NY, VT, PA — Lots/codes: UPC: 00007457410852 Codes: all — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMar 24, 2026
Falcon Trading Co., Inc.: SunRidge Farms Organic Black Beans CERTIFIED ORGANIC BY QAI NET WT. 25 LBS. ORIGEN: ARGENTINA EXPORTADOR: ESPAR SRL FECHA PRODUCCION: 11/13/2023 Item: 003040 UPC: 0867009304…
Potential contamination with pesticides, haloxyfop and thiamethoxam
Product, lots & distribution
SunRidge Farms Organic Black Beans CERTIFIED ORGANIC BY QAI NET WT. 25 LBS. ORIGEN: ARGENTINA EXPORTADOR: ESPAR SRL FECHA PRODUCCION: 11/13/2023 Item: 003040 UPC: 086700930403 — Distribution: U.S. Distribution: CA, CO, HI, MO, TX, VT, WA. Foreign Distribution: None. — Lots/codes: Lot: PND-23-11-36 — Status: Ongoing (voluntary: firm initiated)
Class IIIFoodMar 24, 2026
Falcon Trading Co., Inc.: SunRidge Farms Organic CHILI BEAN BLEND CERTIFIED ORGANIC BY QAI NET WT. 15 LBS Item: 003056 UPC: 086700030561
Potential contamination with pesticides, haloxyfop and thiamethoxam
Product, lots & distribution
SunRidge Farms Organic CHILI BEAN BLEND CERTIFIED ORGANIC BY QAI NET WT. 15 LBS Item: 003056 UPC: 086700030561 — Distribution: U.S. Distribution: CA, CO, HI, MO, TX, VT, WA. Foreign Distribution: None. — Lots/codes: Lots: 3132585, 2652535, 0282570, 2302416. — Status: Ongoing (voluntary: firm initiated)
Class IIIFoodMar 24, 2026
Falcon Trading Co., Inc.: SunRidge Farms Organic SUNSET SOUP MIX CERTIFIED ORGANIC BY QAI NET WT. 25 LBS Item: 013000 UPC: 086700130001
Potential contamination with pesticides, haloxyfop and thiamethoxam
Product, lots & distribution
SunRidge Farms Organic SUNSET SOUP MIX CERTIFIED ORGANIC BY QAI NET WT. 25 LBS Item: 013000 UPC: 086700130001 — Distribution: U.S. Distribution: CA, CO, HI, MO, TX, VT, WA. Foreign Distribution: None. — Lots/codes: Lots: 0062614, 3132500, 2162598, 1252536, 3552404, 2612435. — Status: Ongoing (voluntary: firm initiated)
Class IIIFoodMar 20, 2026
Bee Well Honey Farm & Supply Inc.: Raw & Unfiltered Bee Well Wildflower Honey NET wT. 12 OZ (340g) UPC 8 32587 00003 2, NET WT. 22 OZ (624g) UPC 8 32587 00002 5 & NET WT. 44 OZ (1.25g) UPC 8 32587 00…
High sugar content. The firm was notified by the FDA that sample results were positive for a high C4 sugar content.
Product, lots & distribution
Raw & Unfiltered Bee Well Wildflower Honey NET wT. 12 OZ (340g) UPC 8 32587 00003 2, NET WT. 22 OZ (624g) UPC 8 32587 00002 5 & NET WT. 44 OZ (1.25g) UPC 8 32587 00001 8 100% Pure Honey Bee Well Honey 909 W. Main Street Pickens, SC 29671 — Distribution: Product was shipped to retailers in South Carolina. — Lots/codes: 7/24/29 — Status: Terminated (voluntary: firm initiated)
Class IIIMedicationMar 18, 2026
Island Kinetics, Inc. d.b.a. CoValence Laboratories: Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
Subpotent Drug
Product, lots & distribution
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13 — Distribution: U.S. Nationwide — Lots/codes: Lot 4155D2, 4155D3; Exp. 05/15/2026 — Status: Terminated (voluntary: firm initiated)
Class IIIMedicationMar 18, 2026
Island Kinetics, Inc. d.b.a. CoValence Laboratories: Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Air…
Subpotent Drug
Product, lots & distribution
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04 — Distribution: U.S. Nationwide — Lots/codes: Lot 4212D2; Exp. 07/03/2026 — Status: Terminated (voluntary: firm initiated)
Class IIIMedicationMar 18, 2026
Island Kinetics, Inc. d.b.a. CoValence Laboratories: Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.…
Subpotent Drug
Product, lots & distribution
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05 — Distribution: U.S. Nationwide — Lots/codes: Lot 4212D4; Exp. 07/31/2026 — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMar 16, 2026
Pocas International Corp.: POPPING BOBA RTD PEACH OOLONG TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
Product, lots & distribution
POPPING BOBA RTD PEACH OOLONG TEA 12 X 13.8OZ — Distribution: The product was distributed to the following states: NY, VA, FL, MA, TX, LA, UT, CA and Canada — Lots/codes: Will be provided by firm — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMar 16, 2026
Pocas International Corp.: POPPING BOBA RTD MIXED BERRY HIBISCUS TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
Product, lots & distribution
POPPING BOBA RTD MIXED BERRY HIBISCUS TEA 12 X 13.8OZ — Distribution: The product was distributed to the following states: NY, VA, FL, MA, TX, LA, UT, CA and Canada — Lots/codes: Will be provided by firm — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMar 16, 2026
Pocas International Corp.: POPPING BOBA RTD STRAWBERRY DRAGON F/OOLONG TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
Product, lots & distribution
POPPING BOBA RTD STRAWBERRY DRAGON F/OOLONG TEA 12 X 13.8OZ — Distribution: The product was distributed to the following states: NY, VA, FL, MA, TX, LA, UT, CA and Canada — Lots/codes: Will be provided by firm — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMar 16, 2026
Pocas International Corp.: POPPING BOBA RTD MANGO PASSION FRUIT GREEN TEA 12 X 13.8OZ
Packaging integrity issue that may compromise product quality .
Product, lots & distribution
POPPING BOBA RTD MANGO PASSION FRUIT GREEN TEA 12 X 13.8OZ — Distribution: The product was distributed to the following states: NY, VA, FL, MA, TX, LA, UT, CA and Canada — Lots/codes: Will be provided by firm — Status: Terminated (voluntary: firm initiated)
Class IIIFoodMar 12, 2026
Sato Pharmaceutical Inc.: Yunker(branded) Energy & Health Herbal Supplement with Vitamins; Manufactured by Sato Pharmaceuticals Co. Ltd.; 30ml container. Packed in single serving, 3 units/pack, and 1…
Product does not meet label claim for Vitamin E.
Product, lots & distribution
Yunker(branded) Energy & Health Herbal Supplement with Vitamins; Manufactured by Sato Pharmaceuticals Co. Ltd.; 30ml container. Packed in single serving, 3 units/pack, and 10 units per pack. Single UPC: 49873-916-11 3pack UPC: 49873-916-15 10pack UPC: 49873-916-07 — Distribution: Product was distributed to two domestic consignees who further distribute nationwide. — Lots/codes: Lot: Expiration date: single CXW T Jan-27 3pack CXW T Jan-27 10pack PXW Z Mar-26 10pack XXW W Dec-27 — Status: Ongoing (voluntary: firm initiated)
Class IIIFoodFeb 25, 2026
Tipp Distributors, Inc. dba Novamex: C2O Coconut Water with Pulp (17.5 oz) 15 Pack UPC: 8-50274-00792-8
The outer cardboard box for the canned coconut water has the incorrect Nutrition Facts Panel and Ingredient List, which does not include added sugar (5g per 17.5oz can), while the primary packaging (the can) has the correct Nutrition Facts Panel and Ingredient List.
Product, lots & distribution
C2O Coconut Water with Pulp (17.5 oz) 15 Pack UPC: 8-50274-00792-8 — Distribution: CO, CA, AZ, WA, TX, FL, IL, MO, NJ, MN, MI — Lots/codes: Expiry 4/3/2027 to 6/5/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIFoodFeb 25, 2026
Weikfield Foods Pvt. Ltd.: WeiKFiELD Custard Powder Kesar Pista, Net Wt. 300g (10.6 OZ.), Poly Jar , 24 units per outer case.
The ingredient, Pista, currently declared on our label should be corrected to the standard American nomenclature, Pistachio.
Product, lots & distribution
WeiKFiELD Custard Powder Kesar Pista, Net Wt. 300g (10.6 OZ.), Poly Jar , 24 units per outer case. — Distribution: The adulterated product was distributed to the following states: Iowa, Ohio, North Carlina, New Jersey, & Illinois — Lots/codes: Lot No. 118 — Status: Terminated (voluntary: firm initiated)
Class IIIMedicationFeb 19, 2026
Radnostix: Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 8340…
Failed Tablet/Capsule Specifications
Product, lots & distribution
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35 — Distribution: Nationwide in the US, including Puerto Rico — Lots/codes: Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIIFoodFeb 19, 2026
Super World Trading Inc.: MEI HEONG YUEN TANGERINE FLAVOR ROASTED PEANUTS; NET 9.17 oz (260g); Ingredients: Peanuts, Salt, Sugar, Liquorice, Spices, Sodium Cyclamate, Acesulfame-K, Vanilla, Ethyl Mal…
Products contain cyclamates (banned sweetener)
Product, lots & distribution
MEI HEONG YUEN TANGERINE FLAVOR ROASTED PEANUTS; NET 9.17 oz (260g); Ingredients: Peanuts, Salt, Sugar, Liquorice, Spices, Sodium Cyclamate, Acesulfame-K, Vanilla, Ethyl Maltol; Shelf Life: 18 Months; Manufacturer: Heshan Mei Heong Yuen Food Pte Ltd; Distributor in USA: Super World Trading Inc 28 Varick Ave. Brooklyn, NY 11237 UPC: 6912449124312 — Distribution: CO, CT, DE, FL, GA, IL, MA, MD, MI, NY, NC, NJ, OH, OR, PA, TX, UT, VA, WA — Lots/codes: MFD: 2050721, EXP 20270120, FIRM CODE: 401019 — Status: Terminated (voluntary: firm initiated)
Class IIIFoodFeb 19, 2026
Super World Trading Inc.: MEI HEONG YUEN WALNUT FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Liquorice, Sugar, Spices, Sodium Cyclamate, Acesulfame-K, Vanilla, Ethyl Maltol; Sh…
Products contain cyclamates (banned sweetener)
Product, lots & distribution
MEI HEONG YUEN WALNUT FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Liquorice, Sugar, Spices, Sodium Cyclamate, Acesulfame-K, Vanilla, Ethyl Maltol; Shelf Life: 18 Months; Manufacturer: Heshan Mei Heong Yuen Food Pte Ltd; Distributor in USA: Super World Trading Inc 28 Varick Ave. Brooklyn, NY 11237; UPC: 6912449124282 — Distribution: CO, CT, DE, FL, GA, IL, MA, MD, MI, NY, NC, NJ, OH, OR, PA, TX, UT, VA, WA — Lots/codes: MFD:20250717, EXP:20270116, FIRM CODE: 401020 — Status: Terminated (voluntary: firm initiated)
Class IIIFoodFeb 19, 2026
Super World Trading Inc.: MEI HEONG YUEN GARLIC FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Garlic, Liquorice, Sugar, Saccharin; Shelf Life: 18 Months; Manufacturer: Heshan Me…
Products contain cyclamates (banned sweetener)
Product, lots & distribution
MEI HEONG YUEN GARLIC FLAVOR ROASTED PEANUTS; 9.17 oz (260g); Ingredients: Peanuts, Salt, Garlic, Liquorice, Sugar, Saccharin; Shelf Life: 18 Months; Manufacturer: Heshan Mei Heong Yuen Food Pte Ltd; Distributor in USA: Super World Trading Inc 28 Varick Ave. Brooklyn, NY 11237; UPC: 6912449124329 — Distribution: CO, CT, DE, FL, GA, IL, MA, MD, MI, NY, NC, NJ, OH, OR, PA, TX, UT, VA, WA — Lots/codes: MFD: 20250710, EXP:20270109, FIRM CODE: 401021 — Status: Terminated (voluntary: firm initiated)
Class IIIMedicationFeb 18, 2026
Cipla USA, Inc.: Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Su…
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Product, lots & distribution
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17 — Distribution: U.S.A. Nationwide — Lots/codes: Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027 — Status: Ongoing (voluntary: firm initiated)