FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Gem City Fine Foods, LLC
- Product
- Gem City Fine Foods GF Vegan Chocolate Cake, 25 oz, in recyc…
- Reason
- Incorrect ingredients label on back of product shows "Contains: rBST-free dairy, cage-free eggs, and soy" when the product does not. This statement is found above "Made in a facility that uses Dairy, Eggs and Soy."
- Published
- March 15, 2023
- Distribution
- Distributor in CO.
View recall →
FDA Recall
Terminated
Historical recordClass II
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: Major Pharmaceuticals Indianapolis, IN 46268 USA. NDC 0904-7257-61, UPC 3 09047 25761 4
by The Harvard Drug Group
- Reason
- Packaging defect: observed packaging defect, blister packaging inadequately sealed.
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
by SCA Pharmaceuticals
- Reason
- Subpotent Drug
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25.
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10.
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-302-10.
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- March 8, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25.
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25.
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25.
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.
by Nephron Sterile Compounding Center LLC
- Reason
- Lack of Assurance of Sterility
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark
by DuPont Nutrition USA, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark
by DuPont Nutrition USA, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark
by DuPont Nutrition USA, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.
by Volt Candy Wholesale Club
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.
by Sciegen Pharmaceuticals Inc
- Reason
- Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.
by Alvogen, Inc
- Reason
- Sub-Potent Drug: Out of specification for assay at the 24 month interval.
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark
by DuPont Nutrition USA, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Published
- March 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Snack Innovations Inc.
- Product
- Snack Day by Lidl Vanilla Flavored Kettle Corn Drizzled wit…
- Reason
- May contain undeclared peanut residue.
- Published
- March 8, 2023
- Distribution
- Distributed to distributors in OH, CT, C…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Snack Innovations Inc.
- Product
- The Safe + Fair Food Company Key Lime Pie Drizzled Popcorn K…
- Reason
- May contain undeclared peanut residue.
- Published
- March 8, 2023
- Distribution
- Distributed to distributors in OH, CT, C…
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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