FDA Recall
Terminated
Historical recordClass III
Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.
by Fagron, Inc
- Reason
- Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072, UPC 3-59726-72025-0; (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24, UPC 0-75450-12369-2; (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24, UPC 3-59726-72025-0; (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24, UPC 8-83967-39839-3.
by P & L Development, LLC
- Reason
- Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
by Amneal Pharmaceuticals LLC
- Reason
- Failed Dissolution Specifications
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04
by The Harvard Drug Group
- Reason
- Superpotent Drug; out of specification results for assay (manufacturer)
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS: Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
by Meridian Medical Technologies a Pfizer Company
- Reason
- Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
by Meridian Medical Technologies a Pfizer Company
- Reason
- Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61
by The Harvard Drug Group
- Reason
- Failed Dissolution Specifications
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61
by The Harvard Drug Group
- Reason
- Failed Dissolution Specifications
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
BEYOND MEAT
- Product
- Beyond Beef Feisty Crumble Vegan Gluten-free Non-GMO Weight:…
- Reason
- Undeclared peanuts
- Published
- May 10, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Quaker Oats Co
- Product
- Tropicana 100% JUICE, orange juice From Concentrate with Oth…
- Reason
- One lot of Tropicana orange juice, may have small plastic fragments.
- Published
- May 10, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Aroma Imports Inc
- Product
- Nabelsi Thyme (also known on invoices as Zatar) 450g retail…
- Reason
- Elevated lead levels in product
- Published
- May 10, 2017
- Distribution
- Illinois, Michigan, Ohio, Virginia, and…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Threshold Enterprises Ltd
- Product
- Source Naturals Dietary Supplement Vitamin D-3; Bioactive…
- Reason
- Testing of Vitamin D-3 as a result of a consumer complaint found specific lots to have lower concentrations than product specifications of ingredient labeling.
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Weaver Popcorn Co.
- Product
- Trail's End Chicago Cubs Sweet and Savory Collection Trai…
- Reason
- Product has the potential to be contaminated with Salmonella
- Published
- May 10, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Ton Shen Health Inc
- Product
- Life Rising Formulas SHT Chest Relief, 54 Capsules; Manufact…
- Reason
- Product potentially contaminated with lead.
- Published
- May 10, 2017
- Distribution
- IL
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ardent Mills Llc Usa
- Product
- Safeguard Flour product code 5122286 packaged in 50 lb bags
- Reason
- Product potentially contaminated with Salmonella
- Published
- May 10, 2017
- Distribution
- Product distributed to manufacturers in…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Global Marketing Enterprises, Inc.
- Product
- 40/50 ct/kg (21/25 ct/lb) Farm Raised Head-On Shrimps, Keep…
- Reason
- Product label for frozen shrimp does not declare the presence of sulfites.
- Published
- May 10, 2017
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.
by Isomeric Pharmacy Solution, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- May 3, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.
by Isomeric Pharmacy Solution, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- May 3, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.
by Isomeric Pharmacy Solution, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- May 3, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.
by Isomeric Pharmacy Solution, LLC
- Reason
- Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
- Published
- May 3, 2017
- 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.
Read the full medical disclaimer.