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
Ongoing
Historical recordClass II
Diamond Crystal Brands, Inc.
- Product
- HOUSE BLEND Barbecue SAUCE INGREDIENTS: ***Contains 2% or le…
- Reason
- During a label check the firm noticed that the product was shipped with the incorrect label. The label is missing the following ingredients: Soybean Oil, Onion Powder & EDTA.
- Published
- November 28, 2018
- Distribution
- Product was shipped to the following sta…
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
Pepsico Gatorade Plant
- Product
- Gatorade Vanilla Protein Shake, 330-mL, Primary Package HDPE…
- Reason
- Gatorade is voluntarily recalling a limited number of 12-pack 330-mL Gatorade Vanilla Protein Shake bottles because they may contain Bacillus cereus bacteria.
- Published
- November 28, 2018
- Distribution
- Domestic only: MI, IL
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 →
FDA Recall
Terminated
Historical recordClass III
Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031
by Breckenridge Pharmaceutical, Inc.
- Reason
- Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- Published
- November 21, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- 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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