FDA Recall
Ongoing
Historical recordClass II
Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.
by Fagron Compounding Services
- Reason
- Lack of Assurance of Sterility
- Published
- August 28, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, [NDC 64980-514-05].
by FDC Limited
- Reason
- Defective container; yellow colored spike from cap lodged in the nozzle
- Published
- August 21, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05
by Granules Pharmaceuticals Inc.
- Reason
- Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2
by A-S Medication Solutions LLC
- Reason
- Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064
by EMPOWER CLINIC SERVICES LLC
- Reason
- Lack of Assurance of Sterility
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
by Amneal Pharmaceuticals, LLC
- Reason
- Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.
by Novel Laboratories, Inc. d.b.a Lupin Somerset
- Reason
- Defective container: potential for non-sealed pouches which can lead to product leakage.
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
by MAIN PRODUCTS INC
- Reason
- Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90
by Dr. Reddy's Laboratories, Inc.
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Palmer & Company
- Product
- 1. Palmer Patriotic Pretzels, White & Chocolatey Fudge Cover…
- Reason
- Potential salmonella contamination
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Palmer & Company
- Product
- Favorite Day Bakery White Fudge Mini Cookies, Net Wt 7oz, UP…
- Reason
- Potential salmonella contamination
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Palmer & Company
- Product
- Palmer Frosted Munchy Medley, A mixture of Sweet & Salty Fav…
- Reason
- Potential salmonella contamination
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Palmer & Company
- Product
- Palmer Candy Chow Down Mix, Item 10731, Net Wt 25lbs, UPC 77…
- Reason
- Potential salmonella contamination
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Palmer & Company
- Product
- Snackin' With The Crew! Tiger Treats, Net Wt 8oz., UPC 77232…
- Reason
- Potential salmonella contamination
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Palmer & Company
- Product
- 1. Palmer Patriotic White Fudge Cookies, Net Wt. 7oz, UPC 77…
- Reason
- Potential salmonella contamination
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Palmer & Company
- Product
- 1. Freshness Guaranteed Patriotic Red, White & Blue Pretzel…
- Reason
- Potential salmonella contamination
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Palmer & Company
- Product
- Palmer Candy Cookies & Cream Yummy Chow, Item 10706, Net Wt.…
- Reason
- Potential salmonella contamination
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Palmer & Company
- Product
- 1. Urge! Caramel Swirl Pretzels, White Fudge Coated Pretzel…
- Reason
- Potential salmonella contamination
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Palmer & Company
- Product
- Palmer Patriotic Snack Mix, A Seasonal Mix of Sweet & Salty…
- Reason
- Potential salmonella contamination
- Published
- August 14, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Palmer & Company
- Product
- 1. Palmer Candy Classic Yogurt Pretzels, Net Wt 28 lbs, UPC…
- Reason
- Potential salmonella contamination
- Published
- August 14, 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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