FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
General Mills, Inc
- Product
- Gold Medal Unbleached All Purpose Flour, Enriched, Presifted…
- Reason
- Flour has the potential to be contaminated with Salmonella.
- Published
- May 24, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
REAL GREEK LLC
- Product
- The Vanilla Bean Greek Yogurt 4oz cup is part of the 12-Pack…
- Reason
- Undeclared egg. Lemon Curd yogurt was mis-labeled as Vanilla Bean yogurt and egg is not declared on Vanilla Bean yogurt label.
- Published
- May 24, 2023
- Distribution
- Distributed in Alaska, Oregon, and Washi…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Big Bold Health Holdings Inc
- Product
- Microbiome Rejuvenate dietary supplement, 60 capsules per bo…
- Reason
- Glass fragments.
- Published
- May 24, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61
by The Harvard Drug Group
- Reason
- Product mixup: one foreign tablet found in product.
- Published
- May 17, 2023
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass II
Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Corp., Toronto, Ontario, Canada, M9L 1T9, NDC 60505-0823-6
by Apotex Corp.
- Reason
- Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
- Published
- May 17, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass I
Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC# 31722-629-21.
by Camber Pharmaceuticals Inc.
- Reason
- Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
- Published
- May 17, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Euro-Pharma
- Product
- Multiple Vitamin B Capsules, 60 Capsules, Biologically Activ…
- Reason
- undeclared allergen (milk)
- Published
- May 17, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass I
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
by Gadget Island, Inc
- Reason
- Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- May 10, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass I
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
by Gadget Island, Inc
- Reason
- Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- May 10, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass I
Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by Beyond Health and youth Inc, Seattle, WA 98110, UPC 4 94922 90522 0.
by Gadget Island, Inc
- Reason
- Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- May 10, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.
by Family Dollar Stores, Llc.
- Reason
- CGMP deviation: product outside labeled storage temperature requirements.
- Published
- May 10, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
by Family Dollar Stores, Llc.
- Reason
- CGMP deviation: product outside labeled storage temperature requirements.
- Published
- May 10, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets
by Family Dollar Stores, Llc.
- Reason
- CGMP deviation: product outside labeled storage temperature requirements.
- Published
- May 10, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.
by Family Dollar Stores, Llc.
- Reason
- CGMP deviation: product outside labeled storage temperature requirements.
- Published
- May 10, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0726-30) b) 90 count-bottle (NDC 43063-0726-90)
by PD-Rx Pharmaceuticals, Inc.
- Reason
- CGMP deviations.
- Published
- May 10, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottles (NDC 43063-008-30), b) 90 count-bottles (NDC: 43063-0008-90)
by PD-Rx Pharmaceuticals, Inc.
- Reason
- CGMP deviations.
- Published
- May 10, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90
by PD-Rx Pharmaceuticals, Inc.
- Reason
- CGMP deviations.
- Published
- May 10, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 count-bottle (NDC 43063-0727-30) b) 90 count-bottle (NDC 43063-0727-90)
by PD-Rx Pharmaceuticals, Inc.
- Reason
- CGMP deviations.
- Published
- May 10, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
by PD-Rx Pharmaceuticals, Inc.
- Reason
- CGMP deviations.
- Published
- May 10, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA
by Bryant Ranch Prepack, Inc.
- Reason
- Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
- Published
- May 10, 2023
- 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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