FDA Drug Recalls

  • Ata Int. Inc. Issues Voluntary Nationwide Recall of BLUEFUSION Capsules, due to presence of Undeclared Sildenafil, Tadalafil, Desmethyl carbodenafil, Dithiodesmethyl carbodenafil, Scutellarin and Daidzein

    Thu Mar 21, 2019 2:35PM
    Ata Int. Inc. is voluntarily recalling all lots within expiry of BLUEFUSION Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil,...


  • Hill's Pet Nutrition Expands Voluntary Recall of Select Canned Dog Food for Elevated Vitamin D

    Thu Mar 21, 2019 1:29PM
    Hill's Pet Nutrition today announced it is expanding its recall of select canned dog food products due to elevated levels of vitamin D.


  • Better Made Snack Foods Issues Allergy Alert on Undeclared Milk In 10 Ounce $3.99 Original Potato Chips

    Thu Mar 21, 2019 11:59AM
    The recall was initiated after it was discovered that a package of 10-ounce Original Potato Chips dated 10 AUG 2019 did not contain Original Potato Chips but instead contained Cheddar and Sour Cream Potato Chips which contain milk. Subsequent...


  • Century Snacks LLC Recalls Snak Club Honey Bliss Nut Mix Due to Undeclared Allergen

    Thu Mar 21, 2019 11:23AM
    Century Snacks, LLC of Commerce, CA is recalling all packages of 3-oz. and 5.75-oz. SNAK CLUB HONEY BLISS NUT MIX due to undeclared MILK. People who have an allergy or severe sensitivity to MILK run the risk of serious or life-threatening allergic...


  • Kingston Pharma, LLC RECALLS " DG(TM)/health NATURALS baby Cough Syrup + Mucus" Because of Possible Health Risk

    Wed Mar 20, 2019 6:36PM
    Kingston Pharma, LLC of Massena, NY is recalling Lot KL180157 of its 2-fluid ounce (59 mL) bottles of DG(TM)/health NATURALS baby Cough Syrup + Mucus" because it has the potential to be contaminated with Bacillus cereus/ Bacillus circulans....


  • Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

    Mon Mar 18, 2019 4:59PM
    Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by...


  • Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

    Fri Mar 15, 2019 8:05PM
    Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due...


  • Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

    Fri Mar 15, 2019 7:27PM
    Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide...


  • Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

    Fri Mar 15, 2019 5:57PM
    Hospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV, NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the Hospital/Institution level. The recall was...


  • Surtidoras Bakery Inc. Issues Allergy Alert on Undeclared Milk in Marble Muffin, Banana Muffin, and Blueberry Muffin

    Fri Mar 15, 2019 11:56AM
    Surtidoras Bakery Inc. of Auburn, Washington is recalling Marble Muffin, Banana Muffin, and Blueberry Muffin because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or...


  • Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative

    Wed Mar 13, 2019 5:27PM
    Stokes Healthcare Inc. is voluntarily recalling 1 lot of 81 units of Pilocarpine 0.1% Ophthalmic Solution, to the consumer and veterinarian office levels. The ophthalmic solution has been found to contain a higher level of the preservative...


  • Hometown Food Company Recalls Two Production LOT Codes of Pillsbury(R) Unbleached All-Purpose 5lb Flour Due to Possible Health Risk

    Wed Mar 13, 2019 11:05AM
    Please be advised the Hometown Food Company initiated a limited, voluntary retail-level recall on two specific lot codes of its Pillsbury(R) Unbleached All-Purpose 5 lb Flour (UPC 51500-22241) because it may be contaminated with Salmonella. Only...


  • Claire's Stores, Inc., Announces Voluntary Recall of Three Make-Up Products

    Tue Mar 12, 2019 2:47PM
    Out of an abundance of caution, today Claire's Stores, Inc., announced a voluntary recall of three cosmetic products: Claire's Eye Shadows, Claire's Compact Powder and Claire's Contour Palette. We initiated this voluntary recall after testing by...


  • Fullei Fresh Recalls Organic Bean Sprouts Because of Possible Health Risk

    Fri Mar 8, 2019 5:37PM
    Fullei Fresh of Miami, Florida is voluntarily recalling Organic Bean Sprouts because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail...


  • Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk

    Thu Mar 7, 2019 5:59PM
    Norbrook Laboratories Limited of Newry, Northern Ireland is recalling two lots of Enroflox(R) 100 Injection (enrofloxacin), two lots of Noromectin(R) Injection (ivermectin) and two lots of Ivermax(R) 1% Injection (ivermectin) to the...


  • American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

    Thu Mar 7, 2019 1:37PM
    American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the...


  • McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Life-Line Water

    Wed Mar 6, 2019 5:22PM
    McDaniel Life-Line LLC is voluntarily recalling all lots of Life-Line Water to the consumer level. This product is being recalled because FDA analysis found the product to be contaminated with Pseudomonas aeruginosa.


  • Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement

    Mon Mar 4, 2019 11:48AM
    Weston, Florida, Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain...


  • Sunstone Organics Issues Voluntary Nationwide Recall of Select Kratom Products Due to Potential Contamination by Salmonella

    Fri Mar 1, 2019 4:35PM
    Springfield, OR, Sunstone Organics is voluntarily recalling two lots of Sunstone Organics Kratom. These two lots include Sunstone Organics White Vein Kratom Lot 119 and Sunstone Organics Maeng Da Kratom Lot 124A in both capsules and powder form...


  • Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP

    Fri Mar 1, 2019 3:50PM
    Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected...


  • Asia Foods Distributor Inc. Issues Allergy Alert on Undeclared Milk Allergens in "Nova Salted Biscuit"

    Fri Mar 1, 2019 2:36PM
    Asia foods Distributor Inc of 56-29 56 Drive, Maspeth, NY 11378 is recalling its 14.08 ounce packages of "Nova Salted Biscuit" food treats because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the...


  • AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

    Fri Mar 1, 2019 11:53AM
    AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug...


  • Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

    Thu Feb 28, 2019 7:01PM
    Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible...


  • Joy Gourmet Foods LLC Issues Allergy Alert on Undeclared Sulfites

    Wed Feb 27, 2019 5:43PM
    Joy Gourmet Foods Inc. of Maspeth, NY is recalling its Joy Brand Chutneys and Pastes products because they contain undeclared sulfites.. People who have allergies to sulfites run the risk of serious or life-threatening allergic reaction if they...


  • UTZ Quality Foods Issues Allergy Alert on Undeclared Milk in Bachman 10 Ounce Twist

    Tue Feb 26, 2019 2:56PM
    Utz Quality Foods, LLC., is voluntarily recalling a specific expiration date code of Bachman 10 oz Twist Pretzel packages due to undeclared milk. This recall was initiated after reviewing production records which identified a small number of...


  • ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of ChemoLock(TM) and ChemoClave(R) Vial Spikes Due to the Potential for Burr Particulate

    Tue Feb 26, 2019 11:38AM
    ICU Medical, Inc. today announced a voluntary recall of certain lots of ChemoLock(TM) and ChemoClave(R) Vial Spikes due to the potential for burr particulate originating from the protective cap used in the assembly of the device


  • Southern Specialties Voluntarily Recalls Bagged Green Beans and Butternut Squash Distributed in Southeast because of Possible Health Risk

    Mon Feb 25, 2019 6:54PM
    Southern Specialties Inc. of Pompano Beach, Florida is voluntarily recalling select bags of Marketside brand green beans and butternut squash because they have the potential to be contaminated with Listeria monocytogenes, an organism which can...


  • Golean Detox USA Issues Voluntary Nationwide Recall of Golean DETOX Capsules Due to Presence of Undeclared Sibutramine and Phenolphthalein

    Mon Feb 25, 2019 2:16PM
    Golean Detox USA, Charlotte, NC is voluntarily recalling all lots within expiry of Golean DETOX capsules to the consumer level. FDA analysis has found Golean DETOX capsules to be tainted with undeclared sibutramine and phenolphthalein. Sibutramine...


  • B&G Foods Voluntarily Recalls a Limited Number of Jars of Victoria(R) Marinara Sauce Due to Possible Undeclared Cashew

    Mon Feb 25, 2019 1:27PM
    B&G Foods announced today it is voluntarily recalling 1,280 cases of a single date code of 40 oz. Victoria Marinara Sauce, with a "best by" date of 03/06/2022, after learning that the product may contain cashew allergens that are not declared on...


  • Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

    Mon Feb 25, 2019 8:47AM
    Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in...


  • Meijer Recalls Mint Meijer Brand Ultimate Chocolate Mint Chip Cookies Due to an Undeclared Soy Allergen

    Fri Feb 22, 2019 4:22PM
    Meijer is announcing a voluntary recall of its Meijer brand Ultimate Chocolate Mint Chip Cookies because soy it is not properly declared on the label.


  • Jacques Torres Manufacturing LLC Issues Allergy Alert on Undeclared Milk Allergens in "Jacques" Big Daddy Dark Chocolate Bar

    Wed Feb 20, 2019 9:36PM
    Jacques Torres Manufacturing LLC of Brooklyn, New York is recalling its 2.2 lbs. (1kg), "Jacques" Big Daddy Dark Chocolate Bar, because it contains undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious...


  • Gilda Industries, Inc. Issues Allergy Alert on Undeclared Milk in Butter Pound Cake

    Wed Feb 20, 2019 6:34PM
    Gilda Industries, Inc voluntarily recalls select code dates and manufacturing lot numbers of Panque - Butter pound cake because they may contain undeclared milk . People who have an allergy or severe sensitivity to milk run the risk of a serious...


  • Concord Fresh Success Recall Mild Salsa Seasoning Mix Due To Undeclared Milk Allergen

    Tue Feb 19, 2019 6:46PM
    Concord Foods, LLC of Brockton, Massachusetts is recalling Concord Fresh Success Mild Salsa Seasoning Mix because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergen run the risk of serious or...


  • Chukar Cherries Expands Recall Of Amaretto Rainier Ultra Dark Chocolate Cherries Pouches Due To Undeclared Milk

    Mon Feb 18, 2019 6:54PM
    February 18, 2019, Chukar Cherries of Prosser, WA is recalling 7.5oz Amaretto Rainier Ultra Dark Chocolate Cherries because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or...


  • Smoked Alaska Seafoods, Inc. Recalls 6.5 oz Jars & Cans of Smoked Silver Salmon Because of Possible Health Risk

    Sat Feb 16, 2019 10:02AM
    Smoked Alaska Seafoods, Inc. of Wasilla, AK is recalling all jars and cans of Smoked Silver Salmon in 6.5 oz. containers with the production code of AL81111133 on the bottom of the jar/can because it has the potential to be contaminated with...


  • Nature's Path Foods Recalls A Specific Production Run Of Envirokidz Choco Chimps, Gorilla Munch And Jungle Munch Cereals Due To Undeclared Gluten

    Fri Feb 15, 2019 7:25PM
    Today, Nature's Path Foods announced a voluntary recall of a specific production run of EnviroKidz Choco Chimps, Gorilla Munch and Jungle Munch cereals for they may contain undeclared gluten (wheat and barley). People who have a wheat allergy,...


  • Kingston Pharma, LLC Issues Voluntary Recall of All Lots of "DG(TM) Baby Gripe Water Due to Undissolved Ingredient, Citrus Flavonoid

    Fri Feb 15, 2019 4:17PM
    Kingston Pharma, LLC is voluntarily recalling all lots of "DG(TM) Baby Gripe Water herbal supplement with organic ginger and fennel extracts" to the consumer level due to the presence of an undissolved ingredient, citrus flavonoid.


  • Sid Wainer and Son Initiates Class 2 Recall for Jansal Valley Dukkah Due to Potential Glass Pieces

    Fri Feb 15, 2019 1:31PM
    Sid Wainer and Son of New Bedford, MA is voluntarily recalling Jansal Valley brand Dukkah in 2.5oz containers because of the potential of it containing glass pieces


  • Ottogi America, Inc. Expands Recall on Undeclared Egg in Products

    Wed Feb 13, 2019 10:14AM
    Ottogi America, Inc. announced today it is expanding its recall to include the two items below due to a possibility of containing egg ingredient undeclared on the packages. People who have an allergy or severe sensitivity to eggs run the risk of...