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FDA Drug Recalls

1,463 recalls · Class I, newest first

Class I · High risk Terminated Nov 28, 2022

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only…

Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.

Exela Pharma Sciences LLC NDC 51754-5001-5 D-0079-2023

Class I · High risk Terminated Oct 7, 2022

Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx…

Reason Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.

Viatris Inc D-0058-2023

Class I · High risk Terminated Oct 4, 2022

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only…

Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Exela Pharma Sciences LLC NDC 72572-740-20 D-0023-2023

Class I · High risk Terminated Oct 4, 2022

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only…

Reason Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Exela Pharma Sciences LLC NDC 51754-5001-5 D-0022-2023

Class I · High risk Terminated Sep 29, 2022

Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated…

Reason Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets

Golden State Medical Supply Inc. NDC 60429-027-10 D-0019-2023

Class I · High risk Terminated Sep 14, 2022

Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles, Dist. By…

Reason Chemical Contamination: product found to contain benzene

Salon Technologies International Inc D-0002-2023

Class I · High risk Terminated Aug 22, 2022

PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in…

Reason Presence of particulate matter

Pfizer Inc. NDC 0409-4699-54 D-1540-2022

Class I · High risk Terminated Jul 29, 2022

Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%, packaged in…

Reason Chemical contamination: presence of benzene

Edgewell Personal Care Brands, LLC D-0212-2024

Class I · High risk Terminated Jul 22, 2022

SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC…

Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.

Distributor RFR, LLC. D-1333-2022

Class I · High risk Terminated Jul 21, 2022

SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME…

Reason Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.

Ultra Supplement LLC D-1350-2022

Class I · High risk Terminated Jul 15, 2022

Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Grape Flavor, 10 FL OZ (296 mL)…

Reason Microbial contamination of non-sterile products.

Vi-Jon, LLC NDC 0363-7162-38 D-1510-2022

Class I · High risk Terminated Jul 15, 2022

Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL)…

Reason Microbial contamination of non-sterile products.

Vi-Jon, LLC NDC 0363-8166-38 D-1509-2022

Class I · High risk Terminated Jul 15, 2022

Topcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Cherry Flavor, 10 FL OZ (296 mL)…

Reason Microbial contamination of non-sterile products.

Vi-Jon, LLC NDC 36800-164-38 D-1508-2022

Class I · High risk Terminated Jul 15, 2022

SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemony Flavor, 10 FL OZ (296 mL), Distributed…

Reason Microbial contamination of non-sterile products.

Vi-Jon, LLC NDC 0869-0166-38 D-1507-2022

Class I · High risk Terminated Jul 15, 2022

Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By…

Reason Microbial contamination of non-sterile products.

Vi-Jon, LLC NDC 55910-183-38 D-1506-2022

Class I · High risk Terminated Jul 15, 2022

P, magnesium citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By Publix…

Reason Microbial contamination of non-sterile products.

Vi-Jon, LLC NDC 56062-266-38 D-1505-2022

Class I · High risk Terminated Jul 15, 2022

meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Dist. By Meijer…

Reason Microbial contamination of non-sterile products.

Vi-Jon, LLC NDC 41250-708-38 D-1504-2022

Class I · High risk Terminated Jul 15, 2022

Kroger, Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), Distributed By The Kroger CO…

Reason Microbial contamination of non-sterile products.

Vi-Jon, LLC NDC 30142-899-38 D-1503-2022

Class I · High risk Terminated Jul 15, 2022

EQUALINE magnesium citrate saline laxative, oral solution, (1.745 g/fl oz), DYE FREE lemon flavor, 10 FL OZ (296 mL), Distributed…

Reason Microbial contamination of non-sterile products.

Vi-Jon, LLC NDC 41163-769-38 D-1502-2022

Class I · High risk Terminated Jul 15, 2022

equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), Grape Flavor, Distributed By: Walmart, Inc…

Reason Microbial contamination of non-sterile products.

Vi-Jon, LLC NDC 49035-592-38 D-1501-2022

Class I · High risk Terminated Jul 15, 2022

CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), a) UPC 0 50428…

Reason Microbial contamination of non-sterile products.

Vi-Jon, LLC D-1500-2022

Class I · High risk Terminated Jul 13, 2022

Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further…

Reason Presence of particulate matter: particulate identified as a beetle.

Pfizer Inc. NDC 0409-4699-54 D-1301-2022

Class I · High risk Terminated Jul 5, 2022

Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in…

Reason Labeling: Missing label: Label missing from some prefilled pens.

Mylan Pharmaceuticals Inc NDC 49502-394-71 D-1292-2022

Class I · High risk Terminated Jun 27, 2022

Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957.

Reason Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment…

Loud Muscle Science D-1338-2022

Class I · High risk Terminated Jun 27, 2022

Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.

Reason Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment…

Loud Muscle Science D-1337-2022