FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Neighbors LLC
- Product
- Crazy About Cookies***GLUTEN FREE CHOCOLATE CHIP COOKIE DOUG…
- Reason
- Undeclared almonds on the labeling
- Published
- October 10, 2018
- Distribution
- Products were distributed in the followi…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Church & Dwight Co
- Product
- Trader Darwin s Chewable Peppermint Flavored Melatonin Dieta…
- Reason
- Product is misbranded. Bottles contain another product -GABA Calm Sublingual Orange tablets.
- Published
- October 10, 2018
- Distribution
- The product was distributed to the follo…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
McCormick & Company, Inc. - Flavor Manufacturing Center
- Product
- Meijer Taco Seasoning Mix, Net wt. 4.5 oz.
- Reason
- Product contains undeclared milk.
- Published
- October 10, 2018
- Distribution
- Product shipped predominantly to the Mid…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wismettac Asian Foods (USA) dba Nishimoto Trading Co Ltd
- Product
- EVERYBURGER - Burger-Shaped Chocolate Cookies: NET WT. 2.32…
- Reason
- The ingredient list and allergen information are partially covered by a nutrition sticker. Allergens of wheat, milk and eggs are visible.
- Published
- October 10, 2018
- Distribution
- Multiple states
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FDA Recall
Terminated
Historical recordClass II
Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC 0597-0175-18
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Cross Contamination With Other Products:
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.
by Baxter Healthcare Corporation
- Reason
- Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.
by Hetero Labs Limited Unit V
- Reason
- Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8
by Noven Pharmaceuticals, Inc.
- Reason
- Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass I
Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30
by Hetero Labs Limited Unit V
- Reason
- Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Pin Hsiao & Associates, LLC dba Zen Bakery
- Product
- TRADER JOE'S Cinnamon Coffee Cake; NET WT. 16 OZ (1 LB) 454g…
- Reason
- Product contains undeclared soy lecithin.
- Published
- October 3, 2018
- Distribution
- Direct to: WA, CA, AZ, CT, PA, IL, TX, F…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Swire Coca Cola USA
- Product
- Caffeine-Free Barq s Root Beer 12 Pack, 12 oz cans
- Reason
- Recalling Caffeine-Free Barq s Root Beer 12 Pack due to mislabeling.
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Brett Anthony Foods
- Product
- Gotham Greens Classic Pesto 6.5 oz. plastic cup, 12 cups pe…
- Reason
- Ingredient declaration does not match principal display panel. Product is classic pesto with basil, parmigiano, and pine nuts. Ingredients listed for vegan pesto without parmigiano (milk). Principal display panel correctly identifies product as classic pesto and lists basil, parmigiano, and pine nuts.
- Published
- October 3, 2018
- Distribution
- The product was sold by Whole Foods Mark…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Swanson Health Products, Inc
- Product
- Swanson Ultra, Himalayan Crystal Salt, #SWU403, Net Wt. 35.2…
- Reason
- Himalayan Crystal Salt may contain metal wire pieces.
- Published
- October 3, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Zakah Life LLC
- Product
- Top Shelf White Maeng Da Premium Kratom, Zakah Life Dietary…
- Reason
- The firm distributes dietary supplements which contain Mitragyna speciosa (kratom) a dietary ingredient with inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Also, based on FDA sample positive sample results, the red and green strains are potentially contaminated with Salmonella.
- Published
- October 3, 2018
- Distribution
- Distributed to consumers and retailers i…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Zakah Life LLC
- Product
- Super Green Maeng Da Premium Kratom, Zakah Life Dietary Supp…
- Reason
- The firm distributes dietary supplements which contain Mitragyna speciosa (kratom) a dietary ingredient with inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Also, based on FDA sample positive sample results, the red and green strains are potentially contaminated with Salmonella.
- Published
- October 3, 2018
- Distribution
- Distributed to consumers and retailers i…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Zakah Life LLC
- Product
- Powerful Red Vein Bali Premium Kratom, Zakah Life Dietary Su…
- Reason
- The firm distributes dietary supplements which contain Mitragyna speciosa (kratom) a dietary ingredient with inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Also, based on FDA sample positive sample results, the red and green strains are potentially contaminated with Salmonella.
- Published
- October 3, 2018
- Distribution
- Distributed to consumers and retailers i…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Confidence Inc./Confidence U.S.A. Inc.
- Product
- FP0392, For-Men-10, All Natural Formula to Overall Men's Hea…
- Reason
- Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG), Triacetin, FD&C Yellow #6 (Sunset Yellow FCF), FD&C Red #40 (Allura Red AC), FD&C Blue #1 (Aluminum Lake).
- Published
- October 3, 2018
- Distribution
- Multiple states
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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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