FDA Recall
Ongoing
Historical recordClass II
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 4oz (113.39g), painwizard.com Made in the USA, PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00019 2
by ARG Laboratories, Inc.
- Reason
- Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Tube, NET WT 8 oz (226.79g), Made in the USA, painwizard.com PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00011 6
by ARG Laboratories, Inc.
- Reason
- Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.
by ARG Laboratories, Inc.
- Reason
- Out of Specification for active ingredient
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB Protection, NEW WT. 5 FL OZ (148ML), Distributed by: Bullfrog Brands LLC, PO Box 600207, Dallas, TX 75360 USA. UPC 8 50016 52112 5
by ARG Laboratories, Inc.
- Reason
- Out of Specification for active ingredient
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Gallon Jug 128 fl. oz. (3776 ml), Manufactured for Golden Tiger LLC, Made in USA, UPC 1 82294 00005 5
by ARG Laboratories, Inc.
- Reason
- Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol & MSM, Bottle with pump, NET WT 16 fluid oz / 473.17 ml, Made in USA, www.painwizard.com Pain Wizard LLC.PO Box 1099, Johnstown, CO 80534, UPC 8 63865 00012 3
by ARG Laboratories, Inc.
- Reason
- Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
- 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 vial 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
Terminated
Historical recordClass II
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04
by Lupin Pharmaceuticals Inc.
- Reason
- Defective container: lack of seal integrity.
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00
by Rubicon Research Private Limited
- Reason
- Presence of Foreign Substance: metal in tablet
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08
by Imprimis NJOF, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
by Imprimis NJOF, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/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 71384-513-01
by Imprimis NJOF, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 5, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
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 →
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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