FDA Recall
Terminated
Historical recordClass II
Atropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy
- Reason
- Lack of sterility assurance.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a 50 mL silver jar with a silver cap, Clinique Laboratories, Dist. New York, NY 10022
by Estee Lauder Inc
- Reason
- Defective container: Ineffective seal between the cap and jar of the affected product.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology Drive, Deerfield BEach, FL 33441 SKU#182 UPC 00854582001036
by MSM Nutraceuticals, LLC
- Reason
- Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufactured by: MSM Nutraceuticals, LLC , UPC 8 54582 00118 0
by MSM Nutraceuticals, LLC
- Reason
- Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51 fl oz., Manufactured by: MSM Nutraceuticals, LLC, UPC 8 54582 00119 7.
by MSM Nutraceuticals, LLC
- Reason
- Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027, UPC 8 54582 00120 3.
by MSM Nutraceuticals, LLC
- Reason
- Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-536-37.
by InvaGen Pharmaceuticals, Inc.
- Reason
- Presence of Particulate Matter.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-31.
by InvaGen Pharmaceuticals, Inc.
- Reason
- Presence of Particulate Matter.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-37.
by InvaGen Pharmaceuticals, Inc.
- Reason
- Presence of Particulate Matter.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
ConAgra Foods, INc.
- Product
- Hunts Tomato Paste No Salt Added 6 ounce cans, 12 per whole…
- Reason
- Mold. This situation is due to potential damage to the cans.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Wholesome Treats, Inc.
- Product
- Breads from Anna Classic Herb Bread Mix 19oz, carton
- Reason
- Undeclared flaxseed. Flaxseed was used in the products but is not listed on the product labels.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Wholesome Treats, Inc.
- Product
- Breads from Anna Dairy & Corn Free Bread Mix 19oz, carton
- Reason
- Undeclared flaxseed. Flaxseed was used in the products but is not listed on the product labels.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Wholesome Treats, Inc.
- Product
- Breads from Anna Yeast Free Bread Mix 18.1oz, carton
- Reason
- Undeclared flaxseed. Flaxseed was used in the products but is not listed on the product labels.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Wholesome Treats, Inc.
- Product
- Breads from Anna Banana Bread Mix 14oz, carton
- Reason
- Undeclared flaxseed. Flaxseed was used in the products but is not listed on the product labels.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Wholesome Treats, Inc.
- Product
- Breads from Anna Black Bean Brownie Mix 14oz, carton
- Reason
- Undeclared flaxseed. Flaxseed was used in the products but is not listed on the product labels.
- Published
- April 24, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
LITTLE RED ROOSTER COMPANY
- Product
- NadaMoo! Strawberry Cheesecake Non-Dairy Frozen-Dessert 16 o…
- Reason
- Undeclared almonds
- Published
- April 24, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
Terminated
Historical recordClass I
LEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz is labeled as LEOPARD Miracle of Honey, UPC 8 699415 912859, Manufactured in Turkey, www leopardhoneytr.com.
by USA LESS Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- Published
- April 17, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Thallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi) Volume: 8.8 mL vial, Rx Only, Mfg. by GE Healthcare, Medi-physics, Inc., Arlington Heights, IL 60004. NDC: 17156-299-18
by Medi-Physics Inc. dba GE Healthcare
- Reason
- Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
- Published
- April 17, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
- Published
- April 17, 2019
- 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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