FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mary's Harvest Fresh Foods, Inc.
- Product
- Refrigerated Mary's Harvest Fiesta Corn Salsa 16 oz. UPC# 08…
- Reason
- Fiesta Corn Salsa is recalled due to a potential for contamination with Salmonella or Listeria monocytogenes.
- Published
- December 5, 2018
- Distribution
- Retailers and one distributor in Washing…
View recall →
FDA Recall
Terminated
Historical recordClass II
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Medi-Stat Foam, Antimicrobial Hand Soap, Chloroxylenol 0.5%, 1250 mL (42.3 fl oz), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-503-59
by Ecolab Inc
- Reason
- Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-521-41
by Ecolab Inc
- Reason
- Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11)
by American Health Packaging
- Reason
- Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
by Sciegen Pharmaceuticals Inc
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
by Sciegen Pharmaceuticals Inc
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
by Sciegen Pharmaceuticals Inc
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA.
by Sciegen Pharmaceuticals Inc
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854, Made in the USA.
by Sciegen Pharmaceuticals Inc
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA
by Sciegen Pharmaceuticals Inc
- Reason
- CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand NDC: 55316-014-72, Distributed by DZA Brands, LLC, Salisbury, NC 28147, Scarborough, ME 04074], [HealthMart Pharmacy brand NDC: 62011-0295-1, Distributed by McKessen, One Post Street, San Francisco, CA 94104], [DG health brand NDC: 55910-717-72, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072]
by L. Perrigo Company
- Reason
- Presence of foreign substance: Product found to contain metal particles.
- Published
- November 28, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Harvest Food Group
- Product
- Path of Life All Natural Southwest Quinoa; 10oz., 6 and 12…
- Reason
- Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.
- Published
- November 28, 2018
- Distribution
- AZ, CA, CO, FL, GA, IL, MA, MI, NH, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Harvest Food Group
- Product
- Zinetti Roasted Vegetable Blend; 40lb. bulk case; Keep Fr…
- Reason
- Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.
- Published
- November 28, 2018
- Distribution
- AZ, CA, CO, FL, GA, IL, MA, MI, NH, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Harvest Food Group
- Product
- Signature Select Mexican Style Roasted Corn; 12 oz.; 12/12…
- Reason
- Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.
- Published
- November 28, 2018
- Distribution
- AZ, CA, CO, FL, GA, IL, MA, MI, NH, NJ,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cadence Gourmet LLC
- Product
- Cadence Gourmet Cauliflower & Cheese Net Weight: 10 lbs. (4…
- Reason
- Recall of products manufactured with vegetables from McCain Foods USA and currently under recall for potential Salmonella and/or Listeria Monocytogenes contamination
- Published
- November 28, 2018
- Distribution
- Food service locations in UT, CA, MD, TX…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cadence Gourmet LLC
- Product
- Roasted Vegetable Blend; Net Weight: 30 lbs. (12 x 2.5 lb.…
- Reason
- Recall of products manufactured with vegetables from McCain Foods USA and currently under recall for potential Salmonella and/or Listeria Monocytogenes contamination
- Published
- November 28, 2018
- Distribution
- Food service locations in UT, CA, MD, TX…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cadence Gourmet LLC
- Product
- Cadence Gourmet Balsamic Roasted Vegetables; Net Weight: 10…
- Reason
- Recall of products manufactured with vegetables from McCain Foods USA and currently under recall for potential Salmonella and/or Listeria Monocytogenes contamination
- Published
- November 28, 2018
- Distribution
- Food service locations in UT, CA, MD, TX…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cadence Gourmet LLC
- Product
- Roasted Corn Salsa; Net Weight: 10 lbs. (10 x 1 lb. bags)…
- Reason
- Recall of products manufactured with vegetables from McCain Foods USA and currently under recall for potential Salmonella and/or Listeria Monocytogenes contamination
- Published
- November 28, 2018
- Distribution
- Food service locations in UT, CA, MD, TX…
View recall →
FDA Recall
Terminated
Historical recordClass I
Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3.
by Epic Products, LLC
- Reason
- Marketed Without An Approved NDA/ANDA: product contains undeclared sildenafil, tadalafil, and oxytetracycline, FDA approved drug products making Euphoric an unapproved drug.
- Published
- November 21, 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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