FDA Recall
Terminated
Historical recordClass II
Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ. (355 mL) bottles, Manufactured By: RIJ PHARMACEUTICAL CORPORATION 40 Commercial Avenue Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357, NDC 53807-12612, UPC 53807126122
by RIJ Pharmaceutical LLC
- Reason
- CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- Published
- June 20, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL. OZ. (355 mL), Manufactured By: RIJ Pharmaceutical Corp.40 Commercial Avenue, Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357 NDC 53807-158-12, UPC 353807158123
by RIJ Pharmaceutical LLC
- Reason
- CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- Published
- June 20, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
SDQ Trading Inc.
- Product
- BISCUIT FOOD Cheese Biscuits, The product comes in a 16.5 oz…
- Reason
- Product contains undeclared milk.
- Published
- June 20, 2018
- Distribution
- Retailers in NY
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Divvies LLC
- Product
- simply delicious Divvies SEMI-SWEET PEPPERMINT BARS made to…
- Reason
- Product may contain traces of milk.
- Published
- June 20, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
New Century Snacks LLC
- Product
- Snak Club Tropical Trail Mix: 16 oz. plastic pouch: Ingr…
- Reason
- Firm was notified by customer that some bags of Tropical Trail mix contain Yogurt Trail mix and therefore do not declare milk, soy, wheat or cashews.
- Published
- June 20, 2018
- Distribution
- Alabama, Arizona, California, Colorado,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
R.A.B. Food Group LLC
- Product
- Manischewitz Brand, Dark Chocolate covered Potato Chips, 4.2…
- Reason
- The R.A.B. Food Group LLC dba The Manischewitz Company, 80 Avenue K, Newark, NJ 07105 has initiated a recall of Manischewitz Brand, Dark Chocolate covered Potato Chips, 4.25 oz. /12 per case. because of an undeclared allergen peanut, tree nut and milk.
- Published
- June 20, 2018
- Distribution
- Distribution states MD, PA, WA, CT, NY…
View recall →
FDA Recall
Terminated
Historical recordClass I
Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL
by HOSPIRA INC, LAKE FOREST
- Reason
- Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
- Published
- June 13, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
- Published
- June 13, 2018
- Distribution
- IN, MI, MS, NC, NJ, NY and OH
View recall →
FDA Recall
Terminated
Historical recordClass III
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
by Pharmaceutical Associates Inc
- Reason
- Resuspension problems: Out of specification for appearance and resuspendability.
- Published
- June 13, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1
by Apotex Inc.
- Reason
- Presence of foreign substance: glass particles
- Published
- June 13, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Desly International Corp.
- Product
- Melanie Mini Cookies with Caramel Flavor in a 17.6 oz (500g)…
- Reason
- Products contain undeclared peanuts.
- Published
- June 13, 2018
- Distribution
- CA CT FL GA IL KS KY MA MD ME…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Desly International Corp.
- Product
- Melanie Liubitelskie Cookies in a 17.6 oz (500g) clear plast…
- Reason
- Products contain undeclared peanuts.
- Published
- June 13, 2018
- Distribution
- CA CT FL GA IL KS KY MA MD ME…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GLOBAL COMMODITIES INC
- Product
- WATAN DRY FRUITS PREMIUM QUALITY NATURAL DRIED APRICOT WITH…
- Reason
- Product contains high levels of undeclared sulfites (2901 ppm).
- Published
- June 13, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
BLM Products U. Vertriebsges
- Product
- Priano Rosso Pesto Sauce, 6.7oz glass jar
- Reason
- BLM Prod.-und Vertriebsges.mbH & Co. KG has initiated a voluntary recall of Priano Rosso Pesto Sauce, 6.7 oz. packaged in glass jars due to undeclared allergens egg and milk.
- Published
- June 13, 2018
- Distribution
- Domestic only: Arkansas, California, Con…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dean Foods, Inc.
- Product
- Baskin Robbins Mint Chocolate Chip
- Reason
- Product may contain unlabeled coconut.
- Published
- June 13, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Trader Joes Company
- Product
- Trader Joe's Artisan Bread - Organic French Baguette; (Bro…
- Reason
- FDA was notified by the Canadian Food Inspection Agency of that two lot codes of Trader Joe's Organic French Baguette may be contaminated with Listeria monocytogenes.
- Published
- June 13, 2018
- Distribution
- Distribution Centers in CA and PA - reta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lake Michigan Distilling Co LLC
- Product
- Ethanol Extraction 190 Proof Non-Denatured Grain Alcohol, M…
- Reason
- Lake Michigan Distilling, LLC, dba Ethanol Extraction has initiated a voluntary recall of Ethanol Extraction s 190 Proof Non-Denatured Grain Alcohol due to contamination with methanol which could cause serious injury or death if consumed.
- Published
- June 13, 2018
- Distribution
- Domestic: AK, AL, AR, AZ, CA, CO, CT, DC…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ahold Usa
- Product
- Broccoli cuts, All Natural, No Preservatives, Net Wt 16 OZ;…
- Reason
- Ahold Delhaize received a report from State of CT of finding significant amount of Listeria monocytogenes in a bag of Stop and Shop's Broccoli Cuts, 16 oz.
- Published
- June 13, 2018
- Distribution
- CT, DC, MD, MA, NJ, NY PA, RI, VA and WV
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Driscoll's Strawberry Associates, Inc.
- Product
- Driscoll's Blackberries; 6 oz. clamshell container; Keep r…
- Reason
- Random sample indicated an over tolerance for three pesticides: Thidiazuron; forchlorfenuron; and Thiamethoxam.
- Published
- June 13, 2018
- Distribution
- NY, MO, MI, IN.
View recall →
FDA Recall
Terminated
Historical recordClass I
7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
by Shoreside Enterprises Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- Published
- June 6, 2018
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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