FDA Recall
🇺🇸 United States
TerminatedTerminated: January 17, 2023Historical recordClass III
Karlsburger Foods, Inc.
- Product
- Karlsburger Kitchens NSLP 140 Beef Gravy Mix, Gluten Free.…
- Reason
- undeclared non-wheat gluten, product labeled gluten-free
- Published
- October 26, 2022
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 22, 2023Historical recordClass II
Seeking Health LLC
- Product
- Seeking Health brand Optimal Multivitamin Chewable Dietary S…
- Reason
- The product label claim for copper is 0.5mg, but third-party lab results revealed product contains higher levels of copper.
- Published
- October 26, 2022
- Distribution
- Distributed in AL, AK, AZ, AR, CA, CO, C…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: February 24, 2023Historical recordClass II
Snak King Corporation
- Product
- 16 oz. bags of Trader Joe's Organic Yellow Tortilla Chip Rou…
- Reason
- Bags of Trader Joe's Organic Round Tortilla Chips were found to contain small amounts of Trader Joes Spicy Cheese Crunchies which includes the allergens of milk and soy which are not declared on the label.
- Published
- October 26, 2022
- Distribution
- Affected product was distributed to the…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: October 28, 2022Historical recordClass II
D. F. Stauffer Biscuit Co, Inc.
- Product
- White frosted animal cookies with multi-colored non-pareils…
- Reason
- Potential contamination with foreign material (metal).
- Published
- October 26, 2022
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 11, 2023Historical recordClass II
Eden Foods, Inc
- Product
- Eden Organic Apple Juice in 32floz., 64floz., and 1.82L size…
- Reason
- culling not performed to remove rotted apples, excessive levels of patulin found in 1 lot
- Published
- October 19, 2022
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass III
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
by AuroMedics Pharma LLC
- Reason
- Presence of Particulate Matter: Piece of metal found in a vial
- Published
- October 12, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 25, 2023Historical recordClass II
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.
by CIPLA
- Reason
- Lack of Assurance of Sterility: environmental monitoring failure.
- Published
- October 12, 2022
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass III
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
- Published
- October 12, 2022
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 12, 2023Historical recordClass I
Kenover Marketing Corp.
- Product
- "Mighty Sesame 10.9oz Organic Tahini" in a 10.9oz plastic sq…
- Reason
- Kenover Marketing, 72 New Hook, Bayonne NJ, 07002, has initiated a recall of Mighty Sesame 10.9 Oz Organic Tahini (Squeezable), Squeezable Plastic Jar, 8 Units per Case, UPC: 858313006208 Expiration Date: 3/28/23 because the product is potentially contaminated with Salmonella.
- Published
- October 12, 2022
- Distribution
- Product was distributed to stores locate…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 10, 2023Historical recordClass II
Eden's Answers Inc
- Product
- Sprigs - Lil Ones Sleepy Time: Herbal Dietary Supplement 2o…
- Reason
- High bacterial growth within products
- Published
- October 12, 2022
- Distribution
- Alaska, Alabama, Arkansas, Arizona, Cali…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 10, 2023Historical recordClass II
Eden's Answers Inc
- Product
- Sprigs - Honey Herbal Syrup: Herbal Dietary Supplement 8oz…
- Reason
- High bacterial growth within products
- Published
- October 12, 2022
- Distribution
- Alaska, Alabama, Arkansas, Arizona, Cali…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 10, 2023Historical recordClass II
Eden's Answers Inc
- Product
- Sprigs - Dental Health: Herbal Dietary Supplement 8oz glass…
- Reason
- High bacterial growth within products
- Published
- October 12, 2022
- Distribution
- Alaska, Alabama, Arkansas, Arizona, Cali…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 28, 2023Historical recordClass II
Vanlaw Food Products, Inc
- Product
- WFM 365 Organic Creamy Caesar, 12oz, UPC#: 99482490029, Keep…
- Reason
- Product does not declare the allergens of wheat and soy on label.
- Published
- October 12, 2022
- Distribution
- Product was distributed to 4 distributio…
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FDA Recall
TerminatedTerminated: July 13, 2023Historical recordClass III
Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45
by ALMIRALL, LLC
- Reason
- Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
- Published
- October 5, 2022
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.
by Akorn, Inc.
- Reason
- Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- Published
- October 5, 2022
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031, NDC 61748-015-30
by Akorn, Inc.
- Reason
- Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- Published
- October 5, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 28, 2023Historical recordClass III
ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01
by Leading Pharma, LLC
- Reason
- Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
- Published
- October 5, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 10, 2024Historical recordClass II
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Warren NJ, NDC# 69097-318-86.
by CIPLA
- Reason
- Lack of Assurance of Sterility
- Published
- October 5, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 8, 2023Historical recordClass III
oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.
by QuVa Pharma, Inc.
- Reason
- Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
- Published
- October 5, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 11, 2024Historical recordClass II
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
by Novartis Pharmaceuticals Corporation
- Reason
- CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
- Published
- October 5, 2022
- Distribution
- Nationwide
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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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