Class IFoodApr 2, 2026
Raw Farm LLC: RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE IN THE USA KEEP REFRIGERATED INGREDIENTS: WHOLE RAW MILK, VEGETABLE RENN…
Multi-state outbreak of E. coli O157:H7.
Product, lots & distribution
RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE IN THE USA KEEP REFRIGERATED INGREDIENTS: WHOLE RAW MILK, VEGETABLE RENNET, CULTURES, KOSHER SEA SALT Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001184 — Distribution: U.S. distribution: AZ, CA, CO, FL, GA, IL, IN, MD, NV, TX. Foreign distribution: None. — Lots/codes: 8 oz - BATCH: 20260212, BEST BY: 5/13/2026 and all prior batches/dates. — Status: Ongoing (voluntary: firm initiated)
Class IFoodApr 2, 2026
Raw Farm LLC: RAW FARM SHREDDED RAW CHEDDAR 80 OZ [BULK ITEM] UPC: 835204000194
Multi-state outbreak of E. coli O157:H7.
Product, lots & distribution
RAW FARM SHREDDED RAW CHEDDAR 80 OZ [BULK ITEM] UPC: 835204000194 — Distribution: U.S. distribution: AZ, CA, CO, FL, GA, IL, IN, MD, NV, TX. Foreign distribution: None. — Lots/codes: 80 oz - BATCH: 2026020, BEST BY: 5/6/2026 and all prior batches/dates. — Status: Ongoing (voluntary: firm initiated)
Class IFoodApr 2, 2026
Raw Farm LLC: RAW FARM ORIGINAL RAW CHEDDAR 80 OZ [BULK ITEM] UPC: 835204001160
Multi-state outbreak of E. coli O157:H7.
Product, lots & distribution
RAW FARM ORIGINAL RAW CHEDDAR 80 OZ [BULK ITEM] UPC: 835204001160 — Distribution: U.S. distribution: AZ, CA, CO, FL, GA, IL, IN, MD, NV, TX. Foreign distribution: None. — Lots/codes: 80 oz - BATCH: 20251015-4, BEST BY: 8/11/2026 and all prior batches/dates. — Status: Ongoing (voluntary: firm initiated)
Class IFoodApr 2, 2026
Wawa Beverage Company: Wawa Iced Tea Lemon 16 oz Pint, Plastic bottle
Undeclared Milk Allergen,
Product, lots & distribution
Wawa Iced Tea Lemon 16 oz Pint, Plastic bottle — Distribution: The product has been distributed to the following states: DE, MD, NJ, PA, VA — Lots/codes: UPC: 726191018425 — Status: Ongoing (voluntary: firm initiated)
Class IFoodApr 2, 2026
Wawa Beverage Company: Wawa Diet Iced Tea Lemon Pint (16oz),Plastic bottle
Undeclared Milk Allergen,
Product, lots & distribution
Wawa Diet Iced Tea Lemon Pint (16oz),Plastic bottle — Distribution: The product has been distributed to the following states: DE, MD, NJ, PA, VA — Lots/codes: UPC: 726191018548 — Status: Ongoing (voluntary: firm initiated)
Class IFoodApr 2, 2026
Wawa Beverage Company: Wawa Diet Lemonade Pint (16oz), Plastic bottle
Undeclared Milk Allergen,
Product, lots & distribution
Wawa Diet Lemonade Pint (16oz), Plastic bottle — Distribution: The product has been distributed to the following states: DE, MD, NJ, PA, VA — Lots/codes: UPC: 726191055901 — Status: Ongoing (voluntary: firm initiated)
Class IFoodApr 2, 2026
Wawa Beverage Company: Wawa Fruit Punch Pint (16oz), Plastic bottle
Undeclared Milk Allergen,
Product, lots & distribution
Wawa Fruit Punch Pint (16oz), Plastic bottle — Distribution: The product has been distributed to the following states: DE, MD, NJ, PA, VA — Lots/codes: UPC: 726191018432 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 1, 2026
International Medication Systems Ltd.: EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Compa…
Lack of Assurance of Sterility
Product, lots & distribution
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1 — Distribution: U.S. Nationwide — Lots/codes: Lot Number: EA038A5, Expiration Date: 08/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 1, 2026
Island Kinetics, Inc. d.b.a. CoValence Laboratories: Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
Failed Stability Specifications
Product, lots & distribution
Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9. — Distribution: U.S. Nationwide — Lots/codes: Lot#: 4228D2, 4229D1, Exp.: 07/31/2026 Lot#: 5147D2, Exp.: 04/30/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 1, 2026
Wells Pharma of Houston LLC: Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
cGMP deviations.
Product, lots & distribution
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03 — Distribution: U.S. Nationwide. — Lots/codes: 120325122032719, Exp Date 04/03/2026, 120425122032734 Exp Date 04/04/2026, 120425122032735, Exp Date 04/04/2026, 120925122032781, Exp Date 04/10/2026, 010626122030010, Exp Date, 05/08/2026, 010626122030009, Exp Date 05/08/2026, 010826122030031, Exp Date 05/13/2026, 010826122030032, Exp Date 05/13/2026, 011326122030072, Exp Date 05/15/2026, 011326122030071, Exp Date 05/15/2026, 011626122030107, Exp Date 05/20/2026, 011626122030106, Exp Date 05/20/2026, 011926122030118, Exp. Date, 05/21/2026, 011926122030119, Exp Date, 05/21/2026, 012726122030171, Exp Date, 05/29/2026, 012726122030170, Exp Date… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 1, 2026
Wells Pharma of Houston LLC: fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02.
cGMP deviations.
Product, lots & distribution
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Houston, NDC 73702-202-02. — Distribution: U.S. Nationwide. — Lots/codes: 120925202022769, Expiration Date 04/09/2026, 123125202022883, Expiration Date 05/05/2026, 123125202022884, Expiration Date 05/05/2026 011226202020057, Expiration Date 05/14/2026, 011226202020058, Expiration Date 05/14/2026, 011626202020110, Expiration Date 05/20/2026 012726202020156, Expiration Date 05/28/2026. 012726202020161, Expiration Date 05/28/2026 020226202020195, Expiration Date 06/04/2026 021826202020386, Expiration Date 06/20/2026 022026202020417, Expiration Date 06/24/2026 022026202020424 Expiration Date 06/24/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 1, 2026
Wells Pharma of Houston LLC: fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
cGMP deviations.
Product, lots & distribution
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03. — Distribution: U.S. Nationwide. — Lots/codes: 120125202032701, Exp Date 04/01/2026; 122625202032857, Exp Date 04/25/2026; 122625202032862, Exp Date 04/28/2026, 122625202032863. Exp Date 04/28/2026; 122625202032864, Exp Date 04/28/2026; 122625202032865, Exp Date 04/28/2026, 011226202030062, Exp Date 05/14/2026, 011326202030776, Exp Date 05/15/2026; 011326202030077, Exp Date 05/15/2026, 011626202030111, Exp Date 05/20/2026, 011926202030122, Exp Date 05/21/2026; 011926202030123, Exp Date 05/21/2026, 012726202030159, Exp Date 05/28/2026, 020226202030200, Exp Date 06/04/2026, 020326202030216, Exp Date 06/05/2026, 020426202030234, Exp Date 06/… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 1, 2026
Wells Pharma of Houston LLC: fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25.
cGMP deviations.
Product, lots & distribution
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC 73702-204-25. — Distribution: U.S. Nationwide. — Lots/codes: Lot 011226204250063, Exp Date 05/14/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 1, 2026
Wells Pharma of Houston LLC: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
cGMP deviations.
Product, lots & distribution
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65. — Distribution: U.S. Nationwide. — Lots/codes: Lot 022326203650432; Exp Date 06/25/2026 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 1, 2026
Wells Pharma of Houston LLC: Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
cGMP deviations.
Product, lots & distribution
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31. — Distribution: U.S. Nationwide. — Lots/codes: 120925302312764, Exp Date 04/09/2026, 123125302312879 Exp Date, 05/05/2026, 123125302312880, Exp Date 05/05/2026, 010226302310003, Exp Date 05/06/2026, 010626302310007, Exp Date 05/08/2026, 010626302310008, Exp Date 05/08/2026 020426302310243, Exp Date 06/06/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationApr 1, 2026
Wells Pharma of Houston LLC: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
cGMP deviations.
Product, lots & distribution
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15. — Distribution: U.S. Nationwide. — Lots/codes: Lot 020226202150202, Exp Date 05/05/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIFoodApr 1, 2026
PURE PALM C/O DVD: Label is predominantly green with white lettering in a clear plastic clamshell container. Pure Palm dates- Medjool Dates Net Wt. 16OZ UPC: 852160007005
mislabeled Coconut Date Bites. (product is coconut covered, label is for regular date bites)
Product, lots & distribution
Label is predominantly green with white lettering in a clear plastic clamshell container. Pure Palm dates- Medjool Dates Net Wt. 16OZ UPC: 852160007005 — Distribution: Product was distributed to a single Direct Account with multiple locations across several East Coast states including (Delaware, Pennsylvania, New Jersey, Maryland, New York) — Lots/codes: LOT CODE PP0576D1 BEST BY:02/26/2027 — Status: Terminated (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 IIFoodMar 30, 2026
HEYTEA USA INC: Coconut Drink 1; NET VOLUME: 1L; Ingredients: Coconut water, freshly squeezed coconut gravy, white granulated sugar, emulsion stabilizer [sodium caseinate, mono- and diglycerides fatt…
Product contains undeclared milk.
Product, lots & distribution
Coconut Drink 1; NET VOLUME: 1L; Ingredients: Coconut water, freshly squeezed coconut gravy, white granulated sugar, emulsion stabilizer [sodium caseinate, mono- and diglycerides fatty acid esters, sucrose fatty acid esters]; Storage Condition: Room temperature; Manufactured in: Hainan, China; imported By: HK HEYTEA FOOD AND BEVERAGE MANAGEMENT LIMITED; For catering establishment; UPC: 673367992785 — Distribution: New York, New Jersey, Massachusetts, Virginia, Maryland, California, Washington, Texas — Lots/codes: Batch Numbers: 2025/03/25 2025/04/06 2025/04/12 2025/08/17 2025/09/04 2025/09/08 2025/09/18 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 27, 2026
Appco Pharma LLC: Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-…
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Product, lots & distribution
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11. — Distribution: U.S.A. Nationwide — Lots/codes: Lot:2404160C, Exp.:2026/MAR; 2406253C, Exp.:2026/MAY; 2407311C, Exp.: 2026/JUL; 2407312C, Exp.:2026/JUL; 2408350C, Exp.:2026/JUL; 2505172C, Exp.:2027/MAY; 2506191C, Exp.: 2027/JUN. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 27, 2026
Appco Pharma LLC: Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-…
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Product, lots & distribution
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11. — Distribution: U.S.A. Nationwide — Lots/codes: Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 27, 2026
Appco Pharma LLC: Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-…
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Product, lots & distribution
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11. — Distribution: U.S.A. Nationwide — Lots/codes: Lot:2406255UC, Exp.: 2026/MAY; 2406256UC, Exp.: 2026/JUL; 2407313UC Exp.: 2026/JUL; 2408351UC, Exp.: 2026/JUL; 2408352UC , Exp.: 2026/JUL; 2509311UC, Exp.: 2027/SEP. . — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMar 27, 2026
Blueroot Health, Inc.: Vital Nutrients Aller-C (vitamin C, citrus bioflavonoids, isoquercitrin, and bromelain)100 count bottles and 200 count bottles
Contains undeclared egg, soy, and hazelnut
Product, lots & distribution
Vital Nutrients Aller-C (vitamin C, citrus bioflavonoids, isoquercitrin, and bromelain)100 count bottles and 200 count bottles — Distribution: Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Montana, North Carolina, New Hampshire, New J… — Lots/codes: 100 count bottles - UPC: 693465524114,693465000083 Lot: 25E04-A, 25E04-B, 25E04 Expiration date: 05/27 200 count bottles - UPC:693465524213,693465000090 Lot: 25E04-B Expiration date: 05/27 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 26, 2026
Hetero Labs Limited (Unit V): Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, H…
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Product, lots & distribution
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10 — Distribution: Nationwide in the USA. — Lots/codes: Batch # FD253967, Exp Date: 06/26/2027 — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMar 26, 2026
Zarlengo Italian Ice: Zarlengo's Chocolate Chocolate Chip Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups, 1-gallon bucket/pail and 2-gallon bucket/pail) , Net Wt. 6 fl…
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Product, lots & distribution
Zarlengo's Chocolate Chocolate Chip Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups, 1-gallon bucket/pail and 2-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and round Polyethylene terephthalate cup with peelable paper lid, laminated with heat-sealable plastic, 16 fl oz cups and 32 fl oz cups translucent freezer grade and round High-Density Polyethylene container with lid and 1-Gallon and 2-Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid. — Distribution: IL, IN and TX — Lots/codes: Lot Codes: 6 fl oz cups--- 03026, 00226, 05426, 05726 16 fl oz (or pint) -- 33825 32 fl oz-- 33825 1 gallon-- 03026 — Status: Terminated (voluntary: firm initiated)
Class IIFoodMar 26, 2026
Zarlengo Italian Ice: Zarlengo's Chocolate Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups and 1-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and rou…
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Product, lots & distribution
Zarlengo's Chocolate Gelato packaged in multiple sizes (6 fl oz cups, 16 fl oz cups, 32 fl oz cups and 1-gallon bucket/pail) , Net Wt. 6 fl oz cups - clear freezer grade and round Polyethylene terephthalate cup with peelable paper lid, laminated with heat-sealable plastic, 16 fl oz cups and 32 fl oz cups translucent freezer grade and round High-Density Polyethylene container with lid and 1 Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid. — Distribution: IL, IN and TX — Lots/codes: Lot Codes: 6 fl oz cups--- 00226, 03026, 05426, 33825 16 fl oz (or pint) -- 33825 1 gallon--05726 — Status: Terminated (voluntary: firm initiated)
Class IIFoodMar 26, 2026
Zarlengo Italian Ice: Zarlengo's Double Dark Chocolate Gelato packaged in 1 Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid.
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Product, lots & distribution
Zarlengo's Double Dark Chocolate Gelato packaged in 1 Gallon bucket/pail - white round food and freezer grade High-Density Polyethylene bucket/pail with tamper resistant lid. — Distribution: IL, IN and TX — Lots/codes: Lot Codes: 6 fl oz cups--- 00226, 03026, 05426, 33825 16 fl oz (or pint) -- 33825 1 gallon--05726 — Status: Terminated (voluntary: firm initiated)
Class IIFoodMar 26, 2026
Schreiber Foods Inc: Top Lid Label: Einstein Bros Bagels Honey Almond Double-Whipped Shmear. Cup Label: Plain Whipped Cream Cheese Spread. Net Wt 6 oz (170g). UPC 8 75343 00001 3. Keep Refrigerated.…
Undeclared allergen (almond).
Product, lots & distribution
Top Lid Label: Einstein Bros Bagels Honey Almond Double-Whipped Shmear. Cup Label: Plain Whipped Cream Cheese Spread. Net Wt 6 oz (170g). UPC 8 75343 00001 3. Keep Refrigerated. Made For Einstein Noah Restaurant Group Inc., Lakewood, CO 80228. — Distribution: CA, CO, OR, SC — Lots/codes: Best if Used By: Jul 21 2026 — Status: Terminated (voluntary: firm initiated)
Class IIFoodMar 26, 2026
FINESALER LLC: Alain MILLIAT; MARMELADE ORANGE; 300 g 10.6 oz; packaged in glass jars
Product may contain foreign objects, specifically glass.
Product, lots & distribution
Alain MILLIAT; MARMELADE ORANGE; 300 g 10.6 oz; packaged in glass jars — Distribution: MA — Lots/codes: C250422AT DDM: 04/2028 — Status: Terminated (voluntary: firm initiated)
Class IIMedicationMar 25, 2026
Preferred Pharmaceuticals, Inc.: Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266…
Lack of Assurance of Sterility
Product, lots & distribution
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0 — Distribution: Nationwide within the United States — Lots/codes: Lot #: F1924R, F2024G, F2424E, G2424M, G2624P, J2424M — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 25, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc.…
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Product, lots & distribution
Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1 — Distribution: Nationwide in the USA. — Lots/codes: Lot# AD76252, Exp Date: 6/30/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 25, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc.…
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Product, lots & distribution
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2. — Distribution: Nationwide in the USA. — Lots/codes: Lot# AD76251, Exp Date: 6/30/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 25, 2026
SUN PHARMACEUTICAL INDUSTRIES INC: Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc.…
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Product, lots & distribution
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-3. — Distribution: Nationwide in the USA. — Lots/codes: Lot# AD76250, Exp Date: 6/30/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIFoodMar 25, 2026
Connecticut Crab Company LLC: Crab Cakes various sizes sold to food service
May be temperature abused, which may result in growth of Clostridium botulinum
Product, lots & distribution
Crab Cakes various sizes sold to food service — Distribution: NY and NJ — Lots/codes: Production on March 9, 11, 13, 16 & 18 in 2026 Unit Size: Our crabcakes are custom made and go from .5oz up to 5oz per cake 1.5 - Container Description: They are shipped in shrimp boxes that generally weigh between 4-5lbs 1.6 - Total Package Size: They contain from 20 up to 135 crabcakes per box depending on the cake size — Status: Terminated (voluntary: firm initiated)
Class IIFoodMar 25, 2026
Ethnic Foods Inc: Bombay Kitchen brand Tikka Sev; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO Expeller Pressed Canola Oil, Spices, Salt, FD&C Tomato Color and Citric Acid; CAUTION:…
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Product, lots & distribution
Bombay Kitchen brand Tikka Sev; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO Expeller Pressed Canola Oil, Spices, Salt, FD&C Tomato Color and Citric Acid; CAUTION: May Contain Traces of Peanuts, Cashews and/or Tree Nuts; Manufactured by Bombay Kitchen Foods Port Washington, NY 11050 — Distribution: NJ — Lots/codes: UPC: 808550100085 — Status: Terminated (voluntary: firm initiated)
Class IIFoodMar 25, 2026
Ethnic Foods Inc: Bombay Kitchen brand Punjabi Mix; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO Expeller Pressed Canola Oil, Chana Dal (Split Bengal Gram), Brown Lentils (Masoor),…
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Product, lots & distribution
Bombay Kitchen brand Punjabi Mix; Net Wt 9oz (255g); INGREDIENTS: Chickpea Flour, Water, Non-GMO Expeller Pressed Canola Oil, Chana Dal (Split Bengal Gram), Brown Lentils (Masoor), Chickpeas, Rice Flakes, Puffed Rice, Spices, Sugar, Peanuts, Raisins, Yogurt (pasteurized Grade A Milk and Cultures), Green Chilli, Salt, FD&C tomato Color and Citric Acid; CONTAINS: Peanuts, Milk; CAUTION: May Contain Traces of Peanuts, Cashews and/or Tree Nuts; Manufactured by Bombay Kitchen Foods Port Washington, NY 11050 — Distribution: NJ — Lots/codes: UPC: 808550100016 — Status: Terminated (voluntary: firm initiated)
Class IIMedicationMar 24, 2026
GE Healthcare Ireland Limited: GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.
Presence of particulate matter
Product, lots & distribution
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63. — Distribution: U.S. Nationwide. — Lots/codes: Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; Exp. November 25, 2028 Lot# 17321225; Exp. September 8, 2028 Lot# 17333589; Exp. November 24, 2028 Lot# 17333611; Exp. November 26. 2028 Lot# 17333613; Exp. November 23. 2028 Lot# 17357000; Exp. December 5, 2028 Lot# 17366399; Exp. December 14, 2028… — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 24, 2026
GE Healthcare Ireland Limited: GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.
Presence of particulate matter
Product, lots & distribution
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91. — Distribution: U.S. Nationwide. — Lots/codes: Lot# 17333197; Exp. December 10, 2028 Lot# 17333198; Exp. November 17, 2028 Lot# 17396945; Exp. December 18, 2028 Lot# 17396948; Exp. December 22, 2028 Lot# 17396953; Exp. January 11, 2029 Lot# 17396956; Exp. January 9, 2029 Lot# 17423503; Exp. January 1, 2029 Lot# 17423525; Exp. January 3, 2029 Lot# 17426429; Exp. January 1, 2029 Lot# 17426440; Exp. January 4, 2029 Lot# 17431310; Exp. January 11, 2029 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 24, 2026
The Harvard Drug Group LLC: Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis,…
Failed Dissolution Specifications
Product, lots & distribution
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61 — Distribution: US Nationwide. — Lots/codes: Lot # N02425, Exp Date: 05/31/2027. — Status: Ongoing (voluntary: firm initiated)
Class IFoodMar 24, 2026
Unistel Industries Inc.: SALUTE SEASONINGS; Ground All Spice; Net Wt 16oz; Unistel Industries 650 Blossom Road Rochester, NY 14610; UPC: 7 69203 01617 0
Product may be contaminated with Salmonella.
Product, lots & distribution
SALUTE SEASONINGS; Ground All Spice; Net Wt 16oz; Unistel Industries 650 Blossom Road Rochester, NY 14610; UPC: 7 69203 01617 0 — Distribution: CA, HI, WA — Lots/codes: Lot: A6040, A6054, A6068 — Status: Terminated (voluntary: firm initiated)
Class IFoodMar 24, 2026
AYCO FARMS INC: Fresh Cantaloupe (Whole, Fresh), brand name Ayco, wrapped in food safe plastic bags packed in corrugated cardboard cartons; 6-12 melons per box; individual carton count per label. Kee…
Potential Salmonella Contamination
Product, lots & distribution
Fresh Cantaloupe (Whole, Fresh), brand name Ayco, wrapped in food safe plastic bags packed in corrugated cardboard cartons; 6-12 melons per box; individual carton count per label. Keep refrigerated; store between 36 40¿F. — Distribution: Distributed to PA, FL, CA, NY. No foreign distribution and none to government agencies. — Lots/codes: Lot Numbers: GC26257, GC26270, GC26288, GC26289, GC26290, GC26294, GC26299, GC26301, GC26307, GC26308, GC26311, GC26312, GC26313, GC26318, GC26325, GC26326, GC26328, SCX2601, SCX2606, SCX2611, SCX2614, SCX2622, SCX2625, SCX2629, SCX2633, SGC2601, SGC2602, SGC2607 — Status: Terminated (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 IIFoodMar 23, 2026
Booey's Gourmet LLC: Booey's Dragon's Breath sauce, 15.2oz ringneck glass bottle. UPC on bottle: 7 01936 29222 3. There are 12 bottles per case. Manufactured Exclusively for BOOEYS GOURMET 3924 N. Ca…
Ingredients statement declares Anchovy and Sasame, but Contains statement does not declare Fish (Anchovy) and Sesame.
Product, lots & distribution
Booey's Dragon's Breath sauce, 15.2oz ringneck glass bottle. UPC on bottle: 7 01936 29222 3. There are 12 bottles per case. Manufactured Exclusively for BOOEYS GOURMET 3924 N. Cannon St. Spokane, WA 99205. Label declares: INGREDIENTS: Contains Soy and Wheat. *** Soy Sauce (Water, Soybeans, Wheat, Salt ***Squid Sauce (Anchovy Extract) ***Sesame Oil***. — Distribution: Distributed in WA. — Lots/codes: None — Status: Terminated (voluntary: firm initiated)
Class IIFoodMar 23, 2026
BEF Foods, Inc: Park St. Deli Macaroni & Cheese, NET WT 20 OZ (1 LB 4 OZ) 567g, product packed in plastic tub and placed into paperboard sleeve. 9/20 oz packages per case.
Undeclared allergen (soy lecithin).
Product, lots & distribution
Park St. Deli Macaroni & Cheese, NET WT 20 OZ (1 LB 4 OZ) 567g, product packed in plastic tub and placed into paperboard sleeve. 9/20 oz packages per case. — Distribution: Nationwide — Lots/codes: SUL4839705; SUL4839706; SUL4853771; SUL4853772; SUL4854698; SUL4854700; SUL4854701; SUL4855698; SUL4855699; SUL4855700; SUL4857735; SUL4857736; SUL4857737; SUL4857784; SUL4857785; SUL4866750; SUL4866751; SUL4866752; SUL4866781; SUL4866782; SUL4866783; SUL4866784; SUL4872813; SUL4872814; SUL4872815; SUL4873787; SUL4873788; SUL4886739; SUL4886740; SUL4887698; SUL4887699 — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Fagron Compounding Services: norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Product, lots & distribution
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000049934, Exp.: 4/23/2026; C274-000049963, Exp.:4/24/2026; C274-000050074, Exp.: 4/30/2026; C274-000050123, Exp.:5/1/2026; C274-000050296, Exp.: 5/9/2026; C274-000050420, Exp.: 5/16/2026; C274-000050774, Exp.:6/5/2026; C274-000050924, 6/7/2026; C274-000050961, Exp.: 6/11/2026; C274-000050991, Exp.: 6/12/2026; C274-000051139, Exp.:6/19/2026; C274-000051166, Exp.:6/20/2026; C274-000051198, Exp.:6/21/2026; C274-000051343, Exp.:6/28/2026. — Status: Ongoing (voluntary: firm initiated)
Class IIMedicationMar 20, 2026
Fagron Compounding Services: norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Product, lots & distribution
norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02 — Distribution: Nationwide in the U.S.A. — Lots/codes: Lot: C274-000050004, Exp.: 4/24/2026; C274-000050295, Exp.:5/8/2026; C274-000050773, Exp.: 6/4/2026; C274-000051219, Exp.: 6/21/2026; C274-000051318, Exp.: 6/27/2026; C274-000051602, Exp.: 7/12/2026. — Status: Ongoing (voluntary: firm initiated)