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…
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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
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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
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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
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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
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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
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FDA Recall
Terminated
Historical recordClass III
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01
by Sandoz Inc
- Reason
- Cross Contamination with Other Products
- Published
- November 21, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00
by Sandoz Inc
- Reason
- Cross Contamination with Other Products
- Published
- November 21, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00
by Sandoz Inc
- Reason
- Cross Contamination with Other Products
- Published
- November 21, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00
by Sandoz Inc
- Reason
- Cross Contamination with Other Products
- Published
- November 21, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01
by Sandoz Inc
- Reason
- Cross Contamination with Other Products
- Published
- November 21, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540
by Sandoz Inc
- Reason
- Cross Contamination with Other Products
- Published
- November 21, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0.
by Kadesh International
- Reason
- Non-Sterility: Product manufactured under non-sterile production conditions.
- Published
- November 21, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ 08876 USA. NDC: 66733-958-23
by Eli Lilly & Co
- Reason
- Labeling: Missing label; potential for missing primary container label on the vial.
- Published
- November 21, 2018
- Distribution
- AL, AZ, CA, KS, LA, MS, OH, OR, TN, TX a…
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FDA Recall
Terminated
Historical recordClass II
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
by Zero Xtreme USA
- Reason
- Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
- Published
- November 21, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ukrop's Homestyle Foods, LLC
- Product
- Ukrop's Honey Ham & Swiss on White House Rolls 2CT, NET WT 5…
- Reason
- The products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
- Published
- November 21, 2018
- Distribution
- Product was shipped to 5 different state…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ukrop's Homestyle Foods, LLC
- Product
- Ukrop's Roasted Turkey & Colby Jack Sub, NET WT 8.3 OZ (235g…
- Reason
- The products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
- Published
- November 21, 2018
- Distribution
- Product was shipped to 5 different state…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ukrop's Homestyle Foods, LLC
- Product
- Ukrop's Italian Style Sub , NET WT 8.2 OZ (232g) UPC 722515…
- Reason
- The products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
- Published
- November 21, 2018
- Distribution
- Product was shipped to 5 different state…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ukrop's Homestyle Foods, LLC
- Product
- Ukrop's Honey Turkey & Cheddar on White House Rolls 2CT, NET…
- Reason
- The products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
- Published
- November 21, 2018
- Distribution
- Product was shipped to 5 different state…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ukrop's Homestyle Foods, LLC
- Product
- Ukrop's Honey Ham & Turkey on White House Rolls 4CT, NET WT…
- Reason
- The products may have come into contact with equipment used to process the country ham the supplier recalled for Listeria monocytogenes.
- Published
- November 21, 2018
- Distribution
- Product was shipped to 5 different state…
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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