FDA Recall
Ongoing
Historical recordClass II
Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
by Hyobin LLC
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
PremierZen Black 5000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
by Hyobin LLC
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
by Hyobin LLC
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
by SigmaPharm Laboratories LLC
- Reason
- Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
by SigmaPharm Laboratories LLC
- Reason
- Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 0703-7131-03
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multiple Dose Vial, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-0045-01
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01; ALSO LABELED UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-5145-91 (Novaplus, a registered trademark of Vizient, Inc.)
by Teva Pharmaceuticals USA
- Reason
- Lack of Assurance of Sterility
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CONAGRA BRANDS
- Product
- Udi Gluten Free Double Chocolate Muffins, 10oz (284g) retail…
- Reason
- potential presence of an extraneous material (plastic)
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CONAGRA BRANDS
- Product
- Udi Gluten Free Blueberry Muffins, 10oz (284g) retail contai…
- Reason
- potential presence of an extraneous material (plastic)
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CONAGRA BRANDS
- Product
- Udi Gluten Free Chocolate Zucchini Muffins, 10oz retail cont…
- Reason
- potential presence of an extraneous material (plastic)
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
CONAGRA BRANDS
- Product
- Udi Gluten Free Banana Chocolate Chip Muffins, 10oz retail c…
- Reason
- potential presence of an extraneous material (plastic)
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Forest Mushroom Food Inc.
- Product
- Guan's Enoki Mushroom; Champignon d'enoki 100 g/3.5 oz. and…
- Reason
- State of Massachusetts sampled Enoki Mushrooms and found them to be positive for Listeria monocytogenes.
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
bloommy Inc.
- Product
- "Bloomy*** Biotin Collagen Keratin***Capsules for SKIN, JOIN…
- Reason
- Dietary supplement contains undeclared fish collagen
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Simkins Brothers Sweets, LLC dba Natural Way Food Group
- Product
- Natural Way Almond Butter 16 oz. UPC 850001775175 packaged i…
- Reason
- Potential to contain undeclared peanuts
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pepsico Inc
- Product
- Evolve Vanilla Bean Plant-Based Protein Shake, 11oz "Tetra P…
- Reason
- undeclared soy
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pepsico Inc
- Product
- Evolve Double Chocolate Plant-Based Protein Shake, 11oz "Tet…
- Reason
- undeclared soy
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
NOW Health Group Inc.
- Product
- NOW 4x6 Acidophilus, 60 capsules per retail bottle. Item num…
- Reason
- Foreign capsules included in bottle. Undeclared ingredients.
- Published
- May 26, 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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