FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Fresh Chile Company
- Product
- Sweet & Spicy BBQ sauce, Fresh Chile BBQ sweet & Spicy Mediu…
- Reason
- Label lacked Fish (anchovies) allergen declaration.
- Published
- October 11, 2023
- Distribution
- 6,453 6,475 19 fl oz. (510g) jars distri…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lipari Foods Operating Company, LLC.
- Product
- JLM Roasted Salted Pecan Halves, 10oz clear plastic containe…
- Reason
- Top label says Roasted Salted Pecan Halves, but product is actually filberts / hazelnuts
- Published
- October 11, 2023
- Distribution
- MI OH IL PA FL WV IN MT
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Vive Organic
- Product
- 2 oz VIVE ORGANIC DETOX + IMMUNITY KIWI APPLE SUPERGREENS WE…
- Reason
- Undeclared allergen; coconut
- Published
- October 11, 2023
- Distribution
- Vive Organic did not sell directly to an…
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FDA Recall
Terminated
Historical recordClass III
Clearasil Rapid Rescue Deep Treatment Pads (Salicylic Acid 2%), packaged in 90-count plastic jar, further packaged in case of 6 jars per case, Distributed by RB Health (US), Parsippany, NJ 07054, NDC 63824-431-90
by RB Health (US) LLC
- Reason
- Labeling: Label Error on Declared Strength: The incorrect label on the back of the product packaging.
- Published
- October 4, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526.
by Tolmar, Inc.
- Reason
- Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
- Published
- October 4, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only, Manufactured by SOFIE Co dba SOFIE, Dulles, VA 20166 for Life Molecular Imagining Ltd., NDC 54828-001-50
by Sofie Co dba Sofie
- Reason
- Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).
- Published
- October 4, 2023
- Distribution
- Product was released to one facility in…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Weis Markets, Inc., Ice Cream Division
- Product
- Weis Quality Brownie Moose Tracks Ice Cream (48oz)UPC of 041…
- Reason
- Undeclared egg
- Published
- October 4, 2023
- Distribution
- Retail locations in the following states…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ozona Organics LLC
- Product
- OZONA ORGANICS LIQUID PROBIOTICS & GO HEALTHY LIQUID PROBIOT…
- Reason
- Products contain high water activity in the formula that provides a potential for microbial growth.
- Published
- October 4, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lipari Foods Operating Company, LLC.
- Product
- IO Inspired Organics Organic Raw Walnuts, 5oz bag, UPC 8 636…
- Reason
- Undeclared cashews
- Published
- October 4, 2023
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fresh Unlimited Inc
- Product
- Freshway Foods - Diced Butternut Squash, packaged in 4 pound…
- Reason
- Potential contamination of Listeria monocytogenes
- Published
- October 4, 2023
- Distribution
- US Foods Distribution locations: IN, NC,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Knickerbocker 365 Inc.
- Product
- Knickerbocker Homestyle hamburger buns, 16oz, 8 count in cle…
- Reason
- Undeclared milk
- Published
- October 4, 2023
- Distribution
- MI. The recalled "Homestyle Hamburger Bu…
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FDA Recall
Ongoing
Historical recordClass II
Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002
by HUMANRACE
- Reason
- Subpotent Drug: Product does not contain SPF that is declared on the label.
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01
by HUMANRACE
- Reason
- Subpotent Drug: Product does not contain SPF that is declared on the label.
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass I
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.
by Novartis Pharmaceuticals Corp.
- Reason
- Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle, DISTRIBUTED BY THEKROGER CO. CINCINNATI, OHIO 45202, UPC 011110380807
by Vi-Jon, LLC
- Reason
- Incorrect/Undeclared Excipients.
- Published
- September 27, 2023
- Distribution
- The consignee list includes one distribu…
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FDA Recall
Terminated
Historical recordClass III
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France NDC 47335-506-96
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Subpotent: Out of Specification result observed for low assay
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
by Aurobindo Pharma USA Inc.
- Reason
- Failed dissolution specifications - results obtained were below spec average.
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass II
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case).
by CareFusion 213, LLC
- Reason
- Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
- Published
- September 27, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.
by AMMAN PHARMACEUTICAL INDUSTRIES
- Reason
- Lack of Assurance of Sterility
- Published
- September 27, 2023
- Distribution
- Product was distributed to two (2) direc…
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FDA Recall
Ongoing
Historical recordClass II
TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-099-15.
by AMMAN PHARMACEUTICAL INDUSTRIES
- Reason
- Lack of Assurance of Sterility
- Published
- September 27, 2023
- Distribution
- Product was distributed to two (2) direc…
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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