FDA Recall
Ongoing
Historical recordClass II
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03
by Rising Pharma Holding, Inc.
- Reason
- Presence of Foreign Tablets/Capsules
- Published
- January 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
- Published
- January 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass I
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53
by InvaGen Pharmaceuticals, Inc.
- Reason
- Defective Container: powder may leak out of the pouch
- Published
- January 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01
by Dr. Reddy's Laboratories, Inc.
- Reason
- Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
- Published
- January 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Garden Spot Foods, LLC.
- Product
- Shiloh Farms Organic Salt Free 7 Grain Bread UPC 0-47593-021…
- Reason
- Daily recommended consumption of Cholesterol and Sodium are listed in grams instead of milligrams. Product content information is accurate.
- Published
- January 17, 2024
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Garden Spot Foods, LLC.
- Product
- Shiloh Farms Organic 7 Grain Bread UPC 0-47593-02112-8
- Reason
- Daily recommended consumption of Cholesterol and Sodium are listed in grams instead of milligrams. Product content information is accurate.
- Published
- January 17, 2024
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Garden Spot Foods, LLC.
- Product
- Shiloh Farms Bread for Life Organic 7 Grain UPC 0-47593-0281…
- Reason
- Daily recommended consumption of Cholesterol and Sodium are listed in grams instead of milligrams. Product content information is accurate.
- Published
- January 17, 2024
- Distribution
- Multiple states
View recall →
FDA Recall
Ongoing
Historical recordClass II
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Sterility Assurance
- Published
- January 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
by Azurity Pharmaceuticals, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
- Published
- January 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BioMylz Pvt. Ltd.
- Product
- Spring Valley Biotin & Collagen Liquid, Natural Berry Flavor…
- Reason
- Potential mold contamination
- Published
- January 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5518-06
by TCP HRB ACQUISITON LLC
- Reason
- Chemical contamination: Presence of benzene
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distributed by Idelle Labs, Ltd., El Paso, TX 79912, NDC 41595-5517-06
by TCP HRB ACQUISITON LLC
- Reason
- Chemical contamination: Presence of benzene
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC 00827755070085, NDC 41595-7103-1) and b) 6 oz. (170g) aerosol cans (UPC 00827755070108, NDC 41595-7103-2), Distributed by Idelle Labs, Ltd. El Paso, TX 79912 USA
by TCP HRB ACQUISITON LLC
- Reason
- Chemical contamination: Presence of benzene
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7. Amazon's ASIN# B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ
by Meta Herbal
- Reason
- Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W. Sunset Road, Las Vegas, NV, NDC 72682-8721-3.
by AnazaoHealth Corporation
- Reason
- Presence of Particulate Matter.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML Sterile Multiple-Dose Vial, Rx only, AnazaoHealth, 7465 W Sunset Rd #1200, Las Vegas, NV 89113, NDC 72682-2230-3
by AnazaoHealth Corporation
- Reason
- Presence of Particulate Matter.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 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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