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All recalls8,521 total

M
Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceutic

Subpotent and Superpotent Drug

M
Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceutic

Subpotent and Superpotent Drug

M
Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceutic

Subpotent and Superpotent Drug

R
Rising Pharma Holding, Inc. — Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharma

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

R
Rising Pharma Holding, Inc. — Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Dist

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

R
Rising Pharma Holding, Inc. — Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit

4
4 Earth Farms formerly Mcl Fresh Inc — Organic Carrots. Bulk 1 pound bags. Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC., Commerce, CA 92022 USA

potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Organic Vegetable Medley; Broccoli, Carrots & Cauliflower. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBUT

potential contamination with E. coli O121:H19

F
F&S Fresh Foods, Inc. — WHOLE FOODS MARKET, Organic Carrots & Celery, NET WT. 15 oz (425 g), PERISHABLE KEEP REFRIGERATED, Packed For: Whole Foods Market Austin, TX 78703, Pre-washed and ready to eat

Potential contamination with E. coli O121:H19

F
Fabalish, — Fabalish Inc. , Kickin, Carrot Falafel , 10oz , Cardboard tray inside plastic film inside cardboard box, individual units

Potential E Coli contamination.

4
4 Earth Farms formerly Mcl Fresh Inc — Broccoli Medley, 4Earth Farms, Net Weight 12 oz (340 g) (6 pack/case) Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC

potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Vegetable Medley; Broccoli, Cauliflower, Carrots. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBUTED BY: Wa

potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Vegetable Medley; Broccoli, Cauliflower, Carrots. Washed and ready to prepare; Perishable keep refrigerated. NET WT 32 OZ (2 LB) 907g DISTRIBUTED BY: Walmart In

potential contamination with E. coli O121:H19

F
F&S Fresh Foods, Inc. — WHOLE FOODS MARKET, Organic Carrot Sticks, NET WT. 15 oz (425 g), PERISHABLE KEEP REFRIGERATED, Packed For: Whole Foods Market Austin, TX 78703, Pre-washed and ready to eat

Potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Stir Fry Medley; Carrots, Broccoli, Broccoli Stem, Stem. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBUTED

potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Organic Broccoli Slaw (Salade DE Brocoli), 4Earth Farms, Net Weight/Poids Net (340 g) 12oz (6 pack/case) Washed and ready to prepare, Perishable keep refrigerate

potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Organic Vegetable Medley; Broccoli, Cauliflower, & Carrots. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBU

potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Organic Broccoli Medley, 4Earth Farms, Net Weight 12 oz (340 g) Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC., Com

potential contamination with E. coli O121:H19

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceutica

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceutica

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceutical

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceutica

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceutica

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceutica

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceutica

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceutica

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceutical

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (NDC 0378-1805-77) and b) 1000-count bottles (NDC 0378-1805-10), Rx only, Manufactured for: Mylan Pharmaceutical

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceutical

Superpotent Drug and Subpotent Drug: potency failures obtained

E
Endo USA, Inc. — Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnu

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

E
Endo USA, Inc. — Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ri

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

E
Endo USA, Inc. — Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridg

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

E
Endo USA, Inc. — Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut

Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.

G
Grimmway Enterprises, Inc. dba Grimmway Farms — --- Organic Baby Carrots --- Organic Baby Carrots 25 Grimmway Farms; Organic Baby Carrots 25 Lbs. Grimmway Farms --- Brand --- Grimmway Farms

Potential contamination with E. coli O121:H19

G
Grimmway Enterprises, Inc. dba Grimmway Farms — --- Organic Whole Carrots --- Organic Carrot 125/6 Cal-Organic Farms; Organic Carrot 150/5 Bunny Luv; Organic Carrots 10/5 Lb O-Organic; Organic Carrot

Potential contamination with E. coli O121:H19

G
Grimmway Enterprises, Inc. dba Grimmway Farms — --- Organic Whole Carrots --- Organic Clip Carrots 50 Lbs Cal-Organic Farm; Organic Clip Carrots 50 Lbs Cal-Organic RPC --- Brand --- Cal-Organic

Potential contamination with E. coli O121:H19

G
Grimmway Enterprises, Inc. dba Grimmway Farms — --- Organic Baby Carrots --- Organic Baby Peeled Carrots 12/12oz Steam-to-Serve; Organic Baby Peel Carrot12/12oz Steam-to-Serve RPC --- Brand --- Cal-Or

Potential contamination with E. coli O121:H19

G
Grimmway Enterprises, Inc. dba Grimmway Farms — --- Organic Baby Carrots --- Orangic Baby Peeled Carrots 13/3 BL; Orangic Baby Peeled Carrots 30/1 BL; Org Baby Peeled Carrots 12/2 Wholesome Pantry RPC

Potential contamination with E. coli O121:H19

I
Impossible Foods Inc — Impossible Savory Ground Sausage Meat from plants 14oz chub, UPC 8 16697 02108 8; 8 retail chubs per case

product may contain pieces of metal

N
Northern Tier Bakery LLC — 7-Eleven Chicken Salad Sandwich, UPC 7 63913-79486 1. Net Wt. 7.0 oz (198g), Keep Refrigerated. Mfg By: Supermom's St. Paul Park, MN 55071

Tuna salad sandwiches were labeled as chicken salad sandwiches.

I
Impossible Foods Inc — Impossible Spicy Ground Sausage Meat from plants 14oz chub, UPC 8 16697 02109 5; 8 retail chubs per case

product may contain pieces of metal

E
Evaric Pharmaceuticals Inc. — Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,

Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.

R
Rise Baking Company, LLC dba The New French Bakery Inc. — L'Oven Fresh KETO Friendly Original 6 Tortilla Wraps. Net Wt. 7.8 oz(222g) UPC 4099100271348. Dist & Sold Exclusively By: Aldi, Batavia, I

Foreign Material (metal)

R
Rise Baking Company, LLC dba The New French Bakery Inc. — Bakestone Brothers Pita Bread, 6 White Pita. Net Wt. 11.4 oz(325g) UPC 0 57391-00001 0. Manufactured by PBF pita Bread Factory Ltd, 8000 W

Foreign Material (metal)

R
Rise Baking Company, LLC dba The New French Bakery Inc. — L'Oven Fresh KETO Friendly Multiseed 6 Tortilla Wraps. Net Wt. 7.8 oz(222g) UPC 4099100271355. Dist & Sold Exclusively By: Aldi, Batavia,

Foreign Material (metal)

R
Rise Baking Company, LLC dba The New French Bakery Inc. — Bakestone Brothers Pita Bread, 6 Whole Wheat Pitas. Net Wt. 11.4 oz(325g) UPC 0 57391-01002 6. Manufactured by PBF pita Bread Factory Ltd,

Foreign Material (metal)

B
Braga Fresh Foods LLC — Simple Truth Organic, BROCCOLI FLORETS, STEAM IN BAG, 12oz, BEST IF USED BY NOV 08 2024, PRODUCT OF MEXICO

Potential contamination with Listeria monocytogenes.

K
Keystone Industries — Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30.

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

A
Amerisource Health Services LLC — Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Labor

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit

K
Keystone Industries — Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

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