FDA Recall
🇺🇸 United States
TerminatedTerminated: April 7, 2020Historical recordClass I
WHOLE FOODS MARKET
- Product
- Chocolate Dipped Coconut Macaroon Cookie sold by the individ…
- Reason
- Undeclared milk
- Published
- March 11, 2020
- Distribution
- Kentucky, Maryland, New Jersey, Pennsylv…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 7, 2020Historical recordClass I
WHOLE FOODS MARKET
- Product
- Dark Chocolate Dipped Almond Horn Cookie sold by the individ…
- Reason
- Undeclared milk
- Published
- March 11, 2020
- Distribution
- Kentucky, Maryland, New Jersey, Pennsylv…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 7, 2020Historical recordClass I
WHOLE FOODS MARKET
- Product
- Marble Bundt Cake sold by the slice packaged in Self Serve a…
- Reason
- Undeclared milk
- Published
- March 11, 2020
- Distribution
- Kentucky, Maryland, New Jersey, Pennsylv…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 7, 2020Historical recordClass I
WHOLE FOODS MARKET
- Product
- Chocolate Fudge Mini Bundt Cake sold by the slice packaged i…
- Reason
- Undeclared milk
- Published
- March 11, 2020
- Distribution
- Kentucky, Maryland, New Jersey, Pennsylv…
View recall →
FDA Recall
TerminatedTerminated: August 31, 2020Historical recordClass III
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98.
by Breckenridge Pharmaceutical, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
- Published
- March 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 11, 2023Historical recordClass I
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
- Published
- March 4, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 28, 2022Historical recordClass III
CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01
by Akorn, Inc.
- Reason
- Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
- Published
- March 4, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 28, 2022Historical recordClass III
Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.
by Akorn, Inc.
- Reason
- Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
- Published
- March 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 28, 2022Historical recordClass III
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
by Akorn, Inc.
- Reason
- Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
- Published
- March 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: April 4, 2023Historical recordClass III
TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012
by Golden State Medical Supply Inc.
- Reason
- Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
- Published
- March 4, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 19, 2021Historical recordClass III
Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545
by Teva Pharmaceuticals USA
- Reason
- Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
- Published
- February 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 19, 2021Historical recordClass II
Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39.
by NCS Healthcare of Kentucky Inc
- Reason
- Failed Impurities/Degradation Specification: High Out of Specification Results for Individual Unknown Impurity.
- Published
- February 26, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 4, 2022Historical recordClass II
Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-604-21; NDC Unit Dose 68084-604-11
by American Health Packaging
- Reason
- GMP Deviations: Product bottle may be absent of desiccant.
- Published
- February 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 4, 2022Historical recordClass II
Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-606-21; NDC Unit Dose 68084-606-11
by American Health Packaging
- Reason
- GMP Deviations: Product bottle may be absent of desiccant.
- Published
- February 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 4, 2020Historical recordClass III
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61
by The Harvard Drug Group
- Reason
- Failed Dissolution Specifications: High out of specification result observed at stability studies.
- Published
- February 26, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 9, 2020Historical recordClass II
Suja Life LLC
- Product
- Suja Organic Tropical Dragon Fruit + Veggie Smoothie, 12 oz.…
- Reason
- Firm was notified by supplier of an unapproved herbicide in raw material, flax, that was used in their juice product.
- Published
- February 26, 2020
- Distribution
- One consignee with distribution centers…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: June 9, 2020Historical recordClass II
Suja Life LLC
- Product
- Suja Organic Mango Mojito Fruit + Veggie Smoothie, 12 oz. U…
- Reason
- Firm was notified by supplier of an unapproved herbicide in raw material, flax, that was used in their juice product.
- Published
- February 26, 2020
- Distribution
- One consignee with distribution centers…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 9, 2020Historical recordClass II
Suja Life LLC
- Product
- Suja Organic Ginger Bliss Fruit + Veggie Smoothie, 12 oz. U…
- Reason
- Firm was notified by supplier of an unapproved herbicide in raw material, flax, that was used in their juice product.
- Published
- February 26, 2020
- Distribution
- One consignee with distribution centers…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 9, 2020Historical recordClass II
Suja Life LLC
- Product
- Suja Organic Berry Zest Fruit + Veggie Smoothie, 12 oz. UPC…
- Reason
- Firm was notified by supplier of an unapproved herbicide in raw material, flax, that was used in their juice product.
- Published
- February 26, 2020
- Distribution
- One consignee with distribution centers…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 23, 2020Historical recordClass II
CSM Bakery Products
- Product
- 22.5 lb. cases of 24 15 oz pouches CINNABON CREAM CHEESE FRO…
- Reason
- Pieces of plastic polymer were introduced into the sugar system.
- Published
- February 26, 2020
- 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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