FDA Recall
Ongoing
Historical recordClass II
BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4
by PREQUEL SKIN
- Reason
- Microbial contamination of non-sterile Products -
- Published
- September 18, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
American Outdoor Products, Inc.
- Product
- American Outdoor Products - Astronaut Strawberries, packaged…
- Reason
- Elevated levels of lead
- Published
- September 18, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
by ProRx LLC
- Reason
- Lack of Assurance of Sterility
- Published
- September 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
by ProRx LLC
- Reason
- Lack of Assurance of Sterility
- Published
- September 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02
by ProRx LLC
- Reason
- Lack of Assurance of Sterility
- Published
- September 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
by ProRx LLC
- Reason
- Lack of Assurance of Sterility
- Published
- September 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
by ProRx LLC
- Reason
- Lack of Assurance of Sterility
- Published
- September 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
by ProRx LLC
- Reason
- Lack of Assurance of Sterility
- Published
- September 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
by ProRx LLC
- Reason
- Lack of Assurance of Sterility
- Published
- September 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
by Baxter Healthcare Corporation
- Reason
- Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- Published
- September 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Refresco Beverages US Inc
- Product
- a.) Great Value 8oz Apple Juice in 6pack; PET plastic bottle…
- Reason
- Products contains inorganic arsenic above action level set in guidance to industry.
- Published
- September 11, 2024
- Distribution
- Great Value (8oz):IN, OH, PA, ME, NY, FL…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Unilever North America Supply Chain Company, LLC
- Product
- Popsicle Jolly Rancher Frozen Confection Pop Net Wt 2.71 FL…
- Reason
- Undeclared milk
- Published
- September 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
by Lupin Pharmaceuticals Inc.
- Reason
- Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
- Published
- September 4, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- Published
- September 4, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- Published
- September 4, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
- Published
- September 4, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications: below specification results
- Published
- September 4, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
NOW Foods
- Product
- NOW Real Foods Whole & Unsalted Raw Brazil Nuts 12oz. bag UP…
- Reason
- High mold, yeast, and total viable count
- Published
- September 4, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Colonna Brothers Inc.
- Product
- Ground cinnamon. Supreme Tradition brand ground cinnamon p…
- Reason
- Elevated lead levels in cinnamon
- Published
- September 4, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Prime Food Processing Corp.
- Product
- Prime Food brand Steam Bun with Egg Custard & Coconut Added;…
- Reason
- Products may contain undeclared sesame
- Published
- September 4, 2024
- Distribution
- AZ, CA, CO, CT, FL, GA, HI, IL, KS, KY,…
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.