FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Death Wish Coffee Company, LLC
- Product
- Death Wish Nitro Canned Cold Brew Coffee 11 oz UPC: 8515520…
- Reason
- Potential for Clostridium Botulinum
- Published
- October 25, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, Made in India
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
- Published
- October 18, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417
by United Pharmacy
- Reason
- CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
- Published
- October 18, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
- Published
- October 18, 2017
- Distribution
- CO and OH
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pinnacle Food Group, Llc
- Product
- Birds Eye Baby Sweet Peas, Net Wt. 13 oz. (369g ), Keep Froz…
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes.
- Published
- October 18, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Silver Spring Foods, Inc.
- Product
- waterfront Bistro Tatar Sauce, Net Wt 9 oz. (255g), UPC 2113…
- Reason
- Silver Spring is recalling Waterfront Bistro Tartar Sauce because an incorrect back label does not identify egg.
- Published
- October 18, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Universal Valve, Inopak LTD, Ringwood, NJ
by Inopak Ltd
- Reason
- GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
- Published
- October 11, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Disc Pump, 800 mL Universal Valve, and 1 gallon bottles, Inopak. Ltd, Ringwood, NJ 07456
by Inopak Ltd
- Reason
- GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
- Published
- October 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18 fl oz. bottles and 500, mL 800 mL, and 1000 mL pouches, ALSO labeled as STYLE Antibacterial Hand Soap, Inopak Ltd Ringwood, NJ --- NDC 5031-431-02
by Inopak Ltd
- Reason
- GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
- Published
- October 11, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.
by Pfizer Inc.
- Reason
- CGMP Deviations: Firm failed to control impurity for color change at the API stage.
- Published
- October 11, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Garden Of Life, LLC
- Product
- Garden of Life, Baby Organic Liquid probiotic formula, 56 ml…
- Reason
- The product may pose a choking hazard to newborns due to the thickness of the liquid.
- Published
- October 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pro Bioteks Laboratories
- Product
- Bio35, Vitamin-Mineral Omega Oils Trace Minerals Dietary Sup…
- Reason
- Bio-35 has undeclared soy lecithin.
- Published
- October 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
KIND LLC
- Product
- KIND Dark Chocolate Nuts and Sea Salt Bar-containing 12 /1.…
- Reason
- Outer box fails to declare the allergen walnuts, the individual bar is properly labeled
- Published
- October 11, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540.
by Sandoz Inc
- Reason
- Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
- Published
- October 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 16252-523-01.
by Teva Pharmaceuticals USA
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
- Published
- October 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24
by Pfizer Inc.
- Reason
- Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
- Published
- October 4, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
House Of Thaller Inc
- Product
- Marketside CLASSIC HUMMUS WITH PINE NUTS NET WT. 10 oz (283g…
- Reason
- The firm was notified by their ingredient supplier that the pine nuts may be contaminated with Listeria monocytogenes.
- Published
- October 4, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Lipari Foods, Inc.
- Product
- Sunflower Seeds Honey Roasted, 12oz Tubs & 25lb Bulk
- Reason
- Lipari Foods LLC initiated a voluntary recall of Honey Roasted Sunflower Seeds, 12oz Tubs & 25lb Bulk, due to an off taste following a consumer complaint and mislabeled shelf life.
- Published
- October 4, 2017
- Distribution
- Domestic Only: MI, FL, SC, OH, KY, WI, M…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
House Of Thaller Inc
- Product
- LANTANA White Bean HUMMUS NET WT. 10 oz (283g)
- Reason
- The firm was notified by their ingredient supplier that the pine nuts may be contaminated with Listeria monocytogenes.
- Published
- October 4, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
House Of Thaller Inc
- Product
- FRESH FOODS MARKET Artisan Humus Pine Nuts NET WT 10 oz (283…
- Reason
- The firm was notified by their ingredient supplier that the pine nuts may be contaminated with Listeria monocytogenes.
- Published
- October 4, 2017
- Distribution
- Product was shipped to the following sta…
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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