FDA Recall
Ongoing
Historical recordClass II
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01
by Safecor Health, LLC
- Reason
- cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
- Published
- November 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01
by Safecor Health, LLC
- Reason
- cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
- Published
- November 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, packed in a paper carton/box, MANUFACTURED BY NOVEN PHARMACEUTICALS, INC., Miami, FL 33186 United Sates, NDC 68968-0215-3
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).
- Published
- November 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
- Published
- November 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
- Published
- November 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
- Published
- November 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare: 24416 N 19th Ave, Phoenix, AZ, NDC 81483-0041-1
by Tailstorm Health INC
- Reason
- Lack of Sterility Assurance
- Published
- November 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Failed Impurity/Degradation Specifications
- Published
- November 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Failed Impurity/Degradation Specifications
- Published
- November 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC: 45802-0063-05
by Padagis US LLC
- Reason
- Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability testing.
- Published
- November 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Tablet/Capsule Specifications
- Published
- November 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The JM Smucker Company LLC
- Product
- Great Value Cinnamon Rolls 16.5oz UPC 078742201160, 12 retai…
- Reason
- Pieces of plastic in product
- Published
- November 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The JM Smucker Company LLC
- Product
- Great Value Cheese Danish 16.5 oz UPC 078742201177, 12 retai…
- Reason
- Pieces of plastic in product
- Published
- November 27, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured by: Keystone Industries, 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC 68400-202-10
by Keystone Industries
- Reason
- Subpotent Drug
- Published
- November 20, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
- Published
- November 20, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90
by Cipla USA, Inc.
- Reason
- Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
- Published
- November 20, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98
by Cipla USA, Inc.
- Reason
- Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
- Published
- November 20, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC 29716, USA, Ph: 704-629-8203, www.trinitygold.com, Made in India, UPC 802992001009
by Trinity Gold Nutrition
- Reason
- Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
- Published
- November 20, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).
by Direct Rx
- Reason
- Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
- Published
- November 13, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
by Staska Pharmaceuticals, Inc.
- Reason
- Presence of Particulate Matter: Presence of glass particulates.
- Published
- November 13, 2024
- 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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