FDA Recall
Ongoing
Historical recordClass II
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-512-01
by Imprimis NJOF, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01
by Imprimis NJOF, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr A, Houston, TX 77018, internally assigned NDC 99000-9278-64
by Revive Rx LLC dba Revive Rx Pharmacy
- Reason
- Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52
by Dr. Reddy's Laboratories, Inc.
- Reason
- Lack of Assurance of Sterility: Leaking vials
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
by Genentech, Inc.
- Reason
- Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Nutrition Corp
- Product
- Fresh N Lean brand Crustless Chicken Potato Pot Pie. Package…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 9. 25pc Mother s Day heart ganache box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 8. 16pc Mother s Day ganache box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 7. 7pc Mother s Day heart box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 6. Mother s Day love purse
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 5. 9pc signature box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 4. 6pc signature ganache box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 3. 4pc ganache box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 2. 2pc signature Ganache box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Maribel's Sweets, Inc.
- Product
- 1. 2pc Ganache tote box
- Reason
- Contains undeclared coconut.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01
by American Regent, Inc.
- Reason
- Subpotent product in addition to having out-of-specification results for impurities.
- Published
- May 29, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India.
by SOMERSET THERAPEUTICS LLC
- Reason
- Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
- Published
- May 29, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- May 29, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Natural Waters of Viti Limited
- Product
- Fiji Natural Artesian Water 500 mL (24 pack) Case UPC Code:…
- Reason
- Firm testing revealed Manganese in addition to three bacterial genera.
- Published
- May 29, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Product is MACARONI Salad, but the bottom container is misla…
- Reason
- Undeclared Wheat. Aldi Macaroni Salad was mislabeled as Coleslaw and Coleslaw label does not declare wheat. Macaroni (pasta) is visible through a clear plastic package.
- Published
- May 29, 2024
- Distribution
- Distributed in AL, CT, FL, GA, LA, MA, M…
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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