FDA Recall
Ongoing
Historical recordClass I
0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
by B. Braun Medical Inc
- Reason
- Presence of Particulate Matter
- Published
- August 28, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
by Teva Pharmaceuticals USA, Inc
- Reason
- Superpotent Drug
- Published
- August 28, 2024
- Distribution
- Nationwide
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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
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Refresco Beverages US Inc
- Product
- Great Value; 8oz Apple Juice in 6 pack; 100% Juice; packaged…
- Reason
- Product contains inorganic arsenic above action level set in industry guidance (13.2ppb)
- Published
- August 28, 2024
- Distribution
- Retail locations in: AL, CT, DC, DE, FL,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Advance Food International Inc.
- Product
- Shahzada brand Pulses and Spices; Cinnamon Powder; 7 oz (200…
- Reason
- Product contains elevated levels of lead (2,030 ppb)
- Published
- August 28, 2024
- Distribution
- Multiple states
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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
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pariva LLC
- Product
- Pariva Marinated Labneh Bites Rosemary Garlic; NET WT 8 OZ (…
- Reason
- Product may be contaminated with mold.
- Published
- August 21, 2024
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pariva LLC
- Product
- Pariva Marinated Labneh Bites Mild Tandoori; NET WT 8 OZ (22…
- Reason
- Product may be contaminated with mold.
- Published
- August 21, 2024
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pariva LLC
- Product
- Pariva Marinated Labneh Bites Za'atar; NET WT 8 OZ (225g); I…
- Reason
- Product may be contaminated with mold.
- Published
- August 21, 2024
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
SUBCO FOODS INC
- Product
- Fox's u-bet Vanilla Flavored Syrup, 20oz, UPC 070216241016,…
- Reason
- Customer complaint for bloated bottles. Testing and examination of these lots has revealed they did not meet specifications, including elevated pH and water activity levels. This may be indicative of microbiological activity, and concurrent risk of food-borne illness.
- Published
- August 21, 2024
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
SUBCO FOODS INC
- Product
- Fox's u-bet Sugar-Free Chocolate Flavored Syrup, 18oz, UPC 0…
- Reason
- Customer complaint for bloated bottles. Testing and examination of these lots has revealed they did not meet specifications, including elevated pH and water activity levels. This may be indicative of microbiological activity, and concurrent risk of food-borne illness.
- Published
- August 21, 2024
- Distribution
- Multiple states
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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
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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
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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
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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
Wiers Farm Inc
- Product
- Wiers Farm - Spaghetti Squash packaged in 1lb cartons - case…
- Reason
- Listeria monocyotgenes contamination
- Published
- August 14, 2024
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wiers Farm Inc
- Product
- Wiers Farm - Green Cabbage packaged in 1lb cartons - case si…
- Reason
- Listeria monocyotgenes contamination
- Published
- August 14, 2024
- Distribution
- Multiple states
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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