FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Belgian Yummies
- Product
- Vanilla Ice Cream Cookie Sandwich. Sandwiches packaged in a…
- Reason
- Undeclared Allergen: milk, eggs, wheat, peanuts, and tree nuts.
- Published
- May 15, 2024
- Distribution
- The products were only distributed in th…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
S Martinelli & Company
- Product
- Martinelli's Gold Medal Apple Juice From U.S. Grown Fresh Ap…
- Reason
- Elevated levels of inorganic arsenic.
- Published
- May 15, 2024
- Distribution
- U.S. distribution to the following: AL,…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Sacramento Cookie Factory
- Product
- California Wine Wafer - Mocha Chocolate and Original Wine Wa…
- Reason
- Undeclared allergen (milk)
- Published
- May 15, 2024
- Distribution
- U.S. Distribution to the following state…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Sacramento Cookie Factory
- Product
- Champagne Wafer - Raspberry Almond [Two sizes: retail packag…
- Reason
- Undeclared allergen (milk)
- Published
- May 15, 2024
- Distribution
- U.S. Distribution to the following state…
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FDA Recall
Completed
Historical recordClass III
Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77
by Viatris Inc
- Reason
- Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
- Published
- May 8, 2024
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass III
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
by Hikma Injectables USA Inc
- Reason
- Labeling: Wrong Barcode
- Published
- May 8, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01
by Regeneron Pharmaceuticals Inc
- Reason
- Lack of Assurance of Sterility: Complaints of syringe breakage
- Published
- May 8, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass III
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01
by Imprimis NJOF, LLC
- Reason
- Out of specification for assay
- Published
- May 8, 2024
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass II
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2.
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Failed Dissolution Specifications
- Published
- May 8, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08
by Imprimis NJOF, LLC
- Reason
- Subpotent Drug
- Published
- May 8, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30.
by EPI Health, LLC
- Reason
- CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
- Published
- May 1, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30.
by EPI Health, LLC
- Reason
- CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
- Published
- May 1, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90
by EPI Health, LLC
- Reason
- CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
- Published
- May 1, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications
- Published
- May 1, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53
by Cipla USA, Inc.
- Reason
- Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
- Published
- May 1, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
by FA Online Inc
- Reason
- Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13
by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Reason
- Cross Contamination with Other Products
- Published
- May 1, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass III
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Reason
- Cross Contamination with Other Products
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.
by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Reason
- Cross Contamination with Other Products
- Published
- May 1, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Reason
- Cross Contamination with Other Products
- Published
- May 1, 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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