FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Smucker Natural Foods, Inc.
- Product
- SANTA CRUZ organic BLACKBERRY POMEGRANATE fruit spread NET W…
- Reason
- The firm was notified that the product did not have an ingredient panel or firm information on the label.
- Published
- April 25, 2018
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Smucker Natural Foods, Inc.
- Product
- SANTA CRUZ organic APRICOT fruit spread NET WT 9.5 OZ (270 g…
- Reason
- The firm was notified that the product did not have an ingredient panel or firm information on the label.
- Published
- April 25, 2018
- Distribution
- Product was shipped to the following sta…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Divinity Product Distribution LLC
- Product
- Kratom powder labeled in the following ways 1) Enhance Your…
- Reason
- The firm's dietary supplement products contain kratom (Mitragyna speciosa), a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;
- Published
- April 25, 2018
- Distribution
- Product distributed to the following US…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Divinity Product Distribution LLC
- Product
- Kratom capsules labeled in the following ways: 1) Divinity K…
- Reason
- The firm's dietary supplement products contain kratom (Mitragyna speciosa), a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;
- Published
- April 25, 2018
- Distribution
- Product distributed to the following US…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Avalanche Distributing, LLC
- Product
- Scotcharoo Valanga Gourmet, is a crispy rice cereal with pea…
- Reason
- Scotcharoo product is recalled because the Contains statement does not declare Milk and Soy. Whey, Milk, and Soy Lecithin are declared in the Ingredients statement.
- Published
- April 25, 2018
- Distribution
- distributed in OR and WA
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FDA Recall
Terminated
Historical recordClass III
Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
by InvaGen Pharmaceuticals, Inc.
- Reason
- Failed impurities/degradation specifications: Failure to water content and impurity
- Published
- April 18, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
by United Pacific Co Ltd
- Reason
- CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
- Published
- April 18, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Conzerol (antipoxin) H2O2 Gel, Hydrogen Peroxide Gel 3%, 1.5 oz. tube, OTC, Manufactured for Elrose Labs, Inc., Sanford, FL
by Elroselabs Inc.
- Reason
- cGMP Deviations
- Published
- April 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Molleave, 2 oz bottle, OTC, Manufactured for Elrose Labs, Inc.
by Elroselabs Inc.
- Reason
- cGMP Deviations
- Published
- April 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs, Sanford Fl 32771 USA --- NDC 70223-001-06
by Elroselabs Inc.
- Reason
- cGMP Deviations
- Published
- April 18, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Poppies International INC
- Product
- GFS Belgian Mini Chocolate Topped Eclairs, Keep Frozen, Net…
- Reason
- Products may be contaminated with Listeria monocytogenes
- Published
- April 18, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Pepsi Cola Bottling Company
- Product
- Diet Pepsi; NOW ASPARTAME FREE; 6 PACK; 16 OZ BOTTLES; 6-16…
- Reason
- Case labeling (shrink-wrap labeling) for Diet Pepsi 6 packs (6-16oz bottles) may indicate that the product is "Now Aspartame Free" when the product actually contains aspartame. The individual 16 oz. bottles have aspartame declared in the ingredient statements. The outer wrapping has the incorrect/misdeclared "Now Aspartame Free" declaration.
- Published
- April 18, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Bestco, Inc.
- Product
- Signature Care Calcium Chews; Dietary Supplement; 500 mg Cal…
- Reason
- A packaging revision and lack of revision to the corresponding packaging batch record caused the labeling for the firm's Signature Care brand Calcium Chews dietary supplement to declare a higher level of Vitamin D than the product actually contained. The bag declares 25 mcg (1000 IU) of Vitamin D. The product actually contains 12.5 mcg (500 IU) of Vitamin D.
- Published
- April 18, 2018
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Bob's Red Mill Natural Foods, Inc.
- Product
- Amaranth Flour, Organic Whole Grain, Item Number: 6001C224,…
- Reason
- Amaranth Flour is recalled due to potential for contamination with Salmonella.
- Published
- April 18, 2018
- Distribution
- Distributed in CA, FL, MI, ND, NH, NY, O…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Taylor Shellfish Co
- Product
- Original Smoked Oysters, packaged in vacuum pouches, net wt.…
- Reason
- Original Smoked Oysters, packaged in vacuum pouches, are recalled because the product is not intended to be packaged in a vacuum pouch. This product is cold smoked and low salt and will not meet the minimum standard of Water Phase Salt % for vacuum pouch processing or consumption. Consumption of this product without maintaining the temperature below 38 degrees F may lead to the introduction of Clostridium botulinum toxin.
- Published
- April 18, 2018
- Distribution
- distributed in OR and WA.
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Taylor Shellfish Co
- Product
- Smoked Scallops, packaged and frozen in vacuum pouches, 4 oz…
- Reason
- Smoked Scallops, packaged and frozen in vacuum pouches, are recalled because product did not meet minimum Water Phase Salt (WPS) percentage of 3.5%.
- Published
- April 18, 2018
- Distribution
- distributed in OR and WA.
View recall →
FDA Recall
Terminated
Historical recordClass III
buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
by InvaGen Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications; during stability testing
- Published
- April 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03
by InvaGen Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications; during stability testing
- Published
- April 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.
by Mayne Pharma Inc
- Reason
- Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
- Published
- April 11, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Natural Grocers by Vitamin Cottage
- Product
- Natural Grocers Organic Coconut Smiles, 10 oz. plastic resea…
- Reason
- Coconut smiles product tested positive for Salmonella.
- Published
- April 11, 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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