FDA Recall
OngoingHistorical recordClass II
Burro en Primavera, 2 capsules, UPC 638632431055
by QMart
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
- Published
- May 12, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887
by QMart
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
- Published
- May 12, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
IMPERIAL GOLD 2000, Male Sexual Performance Enhancement, 1 Capsule, UPC 718122040702
by QMart
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
- Published
- May 12, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: April 18, 2022Historical recordClass II
Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC., Made in USA, UPC 6 17135 89467 3.
by Antoto-K
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
- Published
- May 12, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: April 23, 2025Historical recordClass I
Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152; Packaged Exclusively By: A-S Medication Solutions LLC, Libertyville, IL 60048, Product # 6967-0; NDC: 50090-5350-0; contained within Health Essentials Kit, Kit Contains: 1 bottle hand sanitzer, 1 reusable face mask, 1 bottle Acetaminophen 500 mg, 1 bag cough drops, 1 digital thermometer, 50 disposable gloves.
by A-S Medication Solutions LLC.
- Reason
- Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
- Published
- May 12, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 16, 2021Historical recordClass I
Creative Foods Inc
- Product
- Bueno Coffee Substitute Creamy Hazelnut, Gluten-Free, net wt…
- Reason
- Bueno Coffee Substitute Creamy Hazelnut product contains undeclared hazelnut and peanut.
- Published
- May 12, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 16, 2021Historical recordClass I
Creative Foods Inc
- Product
- Bueno Coffee Substitute Pecan Praline, Gluten-Free, net wt.…
- Reason
- Bueno Coffee Substitute Pecan Praline Gluten-Free product contains undeclared peanut and barley (which contains gluten).
- Published
- May 12, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 18, 2022Historical recordClass I
Forest Mushroom Food Inc.
- Product
- Guan's Enoki Mushroom - Champigons d'enoki; Net Wt./ Poids…
- Reason
- Michigan Department of Agriculture and Rural Development sampled Enoki mushrooms and found some samples to be positive for Listeria monocytogenes.
- Published
- May 12, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 18, 2022Historical recordClass III
Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after constitution, Rx only, Distributed by: Genentech, Inc. NDC:50242-175-05
by Genentech Inc
- Reason
- Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead of male fit so they cannot be used in combination with co-packed syringes.
- Published
- May 5, 2021
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 2, 2022Historical recordClass II
Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medical Gas Cylinder, b) C Medical Gas Cylinder; c) D Medical Gas Cylinder; d) E Medical Gas Cylinder; e) M Medical Gas Cylinder; f) H Medical Gas Cylinder, Rx only, Grace Healthcare 1418 31st Avenue Gulfport, MS 39501 228-863-3331
by Grace Healthcare Medical, Inc
- Reason
- cGMP deviations
- Published
- May 5, 2021
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule per box, Distributed by VIEW LIFE Distributors Los Angeles CA 90005 UPC 7 15122 05089 4
by Na Na Collection
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
by Na Na Collection
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5
by S & B Story LLC
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 16, 2021Historical recordClass II
PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4
by Namoo Enterprise LLC
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass II
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
by CareFusion 213, LLC
- Reason
- CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass II
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
by CareFusion 213, LLC
- Reason
- CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass II
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
by CareFusion 213, LLC
- Reason
- Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass II
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400
by CareFusion 213, LLC
- Reason
- Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass I
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
by CareFusion 213, LLC
- Reason
- Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
- Published
- May 5, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 29, 2022Historical recordClass I
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
by CareFusion 213, LLC
- Reason
- Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
- Published
- May 5, 2021
- 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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