FDA Recall
Terminated
Historical recordClass II
Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601
by Banner Pharmacy Services, LLC
- Reason
- Lack of Assurance of Sterility.
- Published
- November 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
General Mills, Inc
- Product
- Cascadian Farm Organic Cinnamon Raisin Granola, Net Wt 15.6…
- Reason
- General Mills is recalling 2 production runs of Cascadian Farm Organic Cinnamon Raisin Granola due to undeclared nut allergen, almond.
- Published
- November 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Whole Foods Market Brand 365, Llc
- Product
- 365 Organic Raisin Bran Flakes 15 oz. packaged in plastic ba…
- Reason
- Undeclared (peanut) allergen: 365 Organic Peanut Butter and Cocoa Balls were packaged into 365 Organic Raisin Bran Flakes boxes.
- Published
- November 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-5858-61.
by The Harvard Drug Group
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
- Published
- October 25, 2017
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbrouck Heights, NJ 07604, NDC 29300-126-13.
by UNICHEM PHARMACEUTICALS USA INC
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
- Published
- October 25, 2017
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bel Brands USA
- Product
- Merkts Port Wine Cheese Spread, Net Wt. 14 oz (396g), UPC 7…
- Reason
- Bel Brands USA is recalling Merkts Port Wine Cheese Spread after being notified by customers that white plastic pieces were found in the product.
- Published
- October 25, 2017
- Distribution
- Nationwide
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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
View recall →
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
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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 →
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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