Drug & Food Recall Alerts
Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Date: 20150903
Status: Terminated
Reason: Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Classification: Class II
Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610
Date: 20200730
Status: Ongoing
Reason: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Classification: Class II
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02
Date: 20200522
Status: Terminated
Reason: Some bottles may contain mixed strengths of the product.
Classification: Class II
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10
Date: 20211026
Status: Terminated
Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Classification: Class II
2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48
Date: 20160505
Status: Terminated
Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Classification: Class II
VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70
Date: 20140708
Status: Terminated
Reason: Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.
Classification: Class III
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004
Date: 20240620
Status: Ongoing
Reason: CGMP deviations
Classification: Class II
Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1352-05
Date: 20180910
Status: Terminated
Reason: Lack of Assurance of Sterility
Classification: Class II
Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22
Date: 20130913
Status: Terminated
Reason: Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Classification: Class II
Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
Date: 20170619
Status: Terminated
Reason: Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Classification: Class II
Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328
Date: 20210315
Status: Terminated
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Classification: Class II
HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
Date: 20150602
Status: Terminated
Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Classification: Class II
Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.
Date: 20131107
Status: Terminated
Reason: Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Classification: Class II
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69
Date: 20220126
Status: Terminated
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Classification: Class II
Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04.
Date: 20180803
Status: Terminated
Reason: Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Classification: Class I
Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Date: 20171116
Status: Terminated
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Classification: Class II
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00409-2634-50
Date: 20221227
Status: Completed
Reason: Lack of sterility assurance
Classification: Class II
Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Date: 20150602
Status: Terminated
Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Classification: Class II
FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 16714036104
Date: 20130702
Status: Terminated
Reason: Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003507, EXP: 6/21/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 0037822500
Classification: Class II
Ling Zhi capsules
Date: 20180119
Status: Terminated
Reason: Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Classification: Class II
CytoDetox, Hydrolyzed Clinoptilolite Fragments, 1 oz./30 mL, OTC Non-Sterile. Dietary supplement.
Date: 20160808
Status: Terminated
Reason: Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.
Classification: Class II
Koi Palace Mini Moon Cake: Single Box - Mini Oolong Tea Paste Unit Size 1/2 lb. and 1/4 lb. in circular box (1 piece) and rectangular boxes (4, 6 or 8 pieces).
Date: 20160831
Status: Terminated
Reason: Mooncake products, manufactured and distributed by Magic Gourmet Trading, Inc. of Milbrae, CA did not have adequate product labeling, including ingredient statements and allergen declaration. Undeclared ingredients include wheat, peanut oil.
Classification: Class II
Crema GuateLinda (Guatemalan Style Cream) in individually soft poly/plastic bags labeled in part: Lacteos Santa Martha Crema GuateLinda Guatemalan Style Cream Net WT 1 LB (16 oz)
Date: 20141010
Status: Terminated
Reason: Virginia State (VDACS) found Listeria monocytogenes in Lacteos Santa Martha Quesito Casero Fresh Curd (Best by 9/27/14), FDA made an inspection, were the environmental samples collected came up positive also for Listeria monocytogenes, also the Oasis Brands Inc. sent finish products samples to a private lab, the Lacteos Santa Martha Cuajada en Hoja Queso Casero Hecho a Mano Fresh Curd (Best By dates of 10/18/14 and 11/25/14) came also positive for Listeria monocytogenes. Oasis Brands Inc. is voluntarily recalling ALL their Lacteos Santa Martha brand products manufactured that are within expiration date.
Classification: Class I
Yellow Onion. Product is labeled in part: "***FC Salsa Mango"***Refrigerate at 34 F***" Item # 302940 FC SALSA MANGO 2/5#. Product is fresh made - Ready To Eat.
Date: 20120727
Status: Terminated
Reason: FreshPoint South Florida is recalling sliced fresh yellow onions and salsa products processed using yellow onions sourced from Gills Onions, LLC which were recalled for Listeria monocytogenes.
Classification: Class I
Pure Planet Organic Parasite Cleanse; Net Wt. 174g Glass Jar; Finished Product Item # 52700 Manufactured and Distributed by: Pure Planet, Rancho Dominguez, CA
Date: 20200224
Status: Terminated
Reason: Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop
Classification: Class III
Coffee Toffee - 4 oz. packages. UPC 6 55974 89001 2. The label is read in parts: "***Ingredients: butter (milk), sugar, bittersweet chocolate 60% (cocoa liquor, emulsifier, soya lecithin, vanilla), coffee, pecans *** Contains: milk & soya ***".
Date: 20180525
Status: Terminated
Reason: Coffee Toffee is recalled because pecan is listed on the Ingredients statement but it is not listed in the Contains statement.
Classification: Class III
XinXing Dried Plum, Net Wt. 5.3 oz.(150g)
Date: 20200401
Status: Terminated
Reason: Product contains dried peaches, but front labeling of product stated dried plums
Classification: Class III
Honey Bourbon Pecans Net Wt. 20 lb. (9.088g) Mfg. By: Trophy Nut Co. Tipp City, OH 45371
Date: 20170505
Status: Terminated
Reason: The firm stated that the product contains undeclared allergens.
Classification: Class II
Gourmet Mix Fruit Delight Net Wt. 64 oz. (1814g) Best If Enjoyed By: 12/03/14, Dist. By: Wegmans Food Markets, Inc., Rochester, NY 14603 UPC 077890241516
Date: 20141209
Status: Terminated
Reason: Possible contamination with Listeria monocytogenes.
Classification: Class I
Marketside 12oz Classic Salad UPC:6-81131-32894-4 SKU: 3107
Date: 20220106
Status: Terminated
Reason: Harvest equipment used in harvesting raw iceberg lettuce was tested by Dole and found to contain Listeria monocytogenes.
Classification: Class I
TranSmart Raspberry Filled frozen unbaked cookie dough, 108/1.75 oz. units, CSM Bakery Products, 3301 Montreal Industrial Way Tucker, GA 30084..
Date: 20140626
Status: Terminated
Reason: Undeclared Allergen; Peanuts.
Classification: Class I
Market Pantry Vanilla Ice Cream 128oz UPC: 85239014943 Target item number: 288-7-307
Date: 20180327
Status: Terminated
Reason: Shipping container from CA to HI was not held at proper temperature which could cause food items to be contaminated with spoilage organisms or pathogens
Classification: Class II
Golden delicious whole fresh apples, Apple Ridge 5lb, 2-3/4 apples, packaged in red net mesh bags " 3lb, 2-1/2 apples, packaged in poly bags " 2lb, 2-1/2 apples, packaged in poly bags " 45ct individual apples on trays with re-useable plastic container boxes " 50ct, individual apples on trays with re-useable plastic container boxes " 55ct, individual apples on trays with re-useable plastic container boxes " 60ct individual apples on trays with re-useable plastic container boxes " 78ct individual apples on trays with re-useable plastic container boxes " 50ct, individual apples on trays in cardboard tray boxes " 55ct, individual apples on trays in cardboard tray boxes
Date: 20171214
Status: Terminated
Reason: Nyblad Orchards Inc. initiated a voluntary recall of multiple varieties of whole fresh apples due to potential contamination with Listeria monocytogenes.
Classification: Class I
Honey Caramels Blue Raspberry. Product available in 5.87 oz. bag, 1 lb. bag, 3 lb. bag, 6 lb. bag. PLU Code for 5.87 oz. bag: 788394 12675 8.
Date: 20220428
Status: Terminated
Reason: Products may potentially contain one or more of the following undeclared tree nuts: Pecans, Almonds, Coconut, Macadamia Nuts, & Walnuts.
Classification: Class II
1. Palmer Candy Drizzled Caramel Corn, Item 19271, Net Wt. 16/5oz tubs, UPC 77343 19271 2. Meijer Drizzled Caramel Popcorn Snack Bowl, Net Wt. 12oz, UPC 60236 18830, 8/12oz case
Date: 20240503
Status: Ongoing
Reason: Potential salmonella contamination
Classification: Class I
Grape Fanta, Grape Flavored Soda, 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA
Date: 20180212
Status: Terminated
Reason: Sharp edges were observed on several of the cans which have the potential of causing cuts on the mouths of consumers who use the product.
Classification: Class II
ELITE MILK CHOCOLATE COATED RICE CAKES UPC:815871011884 NET WT 2.47OZ (70 g)
Date: 20220428
Status: Terminated
Reason: Potential contamination with Salmonella
Classification: Class I
H&NATURAL 2 PACK! BRAZIL SEED 60 PIECES, PURE NATURAL SEMILLA DE BRASIL FOR 60 DAYS, 5 GRAMS PER BOX, 2 BLACK BOXES.
Date: 20240209
Status: Ongoing
Reason: Product recalled due to the presence of yellow oleander and its components in the product.
Classification: Class I
Tiny Isle Chocolate Truffles Macadamia Nut: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
Date: 20140725
Status: Terminated
Reason: Candy was made using carob powder that is currently under recall by the direct supplier due to potential Salmonella contamination.
Classification: Class I
San Marco Premium Dough on Parchment: packaged as 8in, 14in
Date: 20230718
Status: Terminated
Reason: Undeclared Allergen - Soy Flour
Classification: Class II
