FDA Recall
Terminated
Historical recordClass II
Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
by Teva Pharmaceuticals USA
- Reason
- Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
by ACCORD HEALTHCARE, INC.
- Reason
- Failed tablet/capsule specification: missing break line on the 5mg tablet.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%, packaged in (a) 60 g (NDC 50222-501-06), and (b)120 g (50222-501-66) tubes, Rx Only, Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12 Ireland, Distributed by: LEO Pharma Inc. 1 Sylvan Way, Parsippany, NJ 07054.
by LEO PHARMA INC
- Reason
- Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4
by Actavis Inc
- Reason
- Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072 India, NDC 65862-527-30
by Aurobindo Pharma USA Inc
- Reason
- Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
NOW Foods
- Product
- NOW¿ Multi-Food 1 Tablets, One Tablet Daily, 90 tablets, A D…
- Reason
- Product's supplement fact panel incorrectly states that the product contains 75 mg (milligrams) of Molybdenum, when it actually contains 75 mcg (micrograms).
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Two Little Guys Company
- Product
- Joe Chips Retro Potato Chips Sour Cream & Toasted Onion Di…
- Reason
- Joe Chips Sour Cream & Toasted Onion Retro Potato Chips contains a seasoning with a milk powder ingredient that may be contaminated with Salmonella although firm testing has not revealed the presence of the bacteria.
- Published
- February 22, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Yum Retaurants International
- Product
- Pizza Hut Creamy Alfredo sauce, case size 40 lbs. 8 bags per…
- Reason
- Foreign object in alfredo sauce. Likely flexible plastic.
- Published
- February 22, 2017
- Distribution
- TX. NC, NY, FL, WI, KY, MI, CA, TN, GA,…
View recall →
FDA Recall
Terminated
Historical recordClass III
Aripiprazole Tablets, 2 mg, 30-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9; Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-3075-3.
by Apotex Inc.
- Reason
- Superpotent Drug: Product may not meet specifications throughout shelf life.
- Published
- February 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00
by Aurobindo Pharma USA Inc
- Reason
- Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.
- Published
- February 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771.
by VistaPharm, Inc.
- Reason
- Defective Container: Leakage of unit dose cups that may occur at the seal.
- Published
- February 15, 2017
- Distribution
- Domestic: AL, AZ, CA, CO, CT, FL, GA, HI…
View recall →
FDA Recall
Terminated
Historical recordClass III
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
- Published
- February 15, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Blommer Chocolate Co., Inc.
- Product
- Cocie High Protein 90 White Confectionery Discs - MB, NET WT…
- Reason
- Possible contamination of product with Salmonella as product includes the recalled milk and buttermilk powders .
- Published
- February 15, 2017
- Distribution
- IN, VT, IL, GA, IA, NJ, CA, PA, Ontario,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Blommer Chocolate Co., Inc.
- Product
- Butterscotch Drops - MB 1000 [or 4000] Count; NET WT: 50 LBS
- Reason
- Possible contamination of product with Salmonella as product includes the recalled milk and buttermilk powders .
- Published
- February 15, 2017
- Distribution
- IN, VT, IL, GA, IA, NJ, CA, PA, Ontario,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Blommer Chocolate Co., Inc.
- Product
- 70 Milk Confectionery Coating - MB, NET WT: 2000 LBS
- Reason
- Possible contamination of product with Salmonella as product includes the recalled milk and buttermilk powders.
- Published
- February 15, 2017
- Distribution
- IN, VT, IL, GA, IA, NJ, CA, PA, Ontario,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Blommer Chocolate Co., Inc.
- Product
- 34 White Confectionery Coating
- Reason
- Possible contamination of product with Salmonella as product includes the recalled milk and buttermilk powders .
- Published
- February 15, 2017
- Distribution
- IN, VT, IL, GA, IA, NJ, CA, PA, Ontario,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Franklin Farms East
- Product
- All Dairy Blend FFE-9967: Lot # s 1609214-16, 5,050 pounds,…
- Reason
- Franklin Farms East & Meadow Mountain Nutritional have initiated a recall because several products of theirs have the potential to be contaminated with Salmonella.
- Published
- February 15, 2017
- Distribution
- Georgia, Pennsylvania, and Alabama
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Franklin Farms East
- Product
- Buttermilk Solids FFE-8906: Lot # s 1609221-22, 5,050 pound…
- Reason
- Franklin Farms East & Meadow Mountain Nutritional have initiated a recall because several products of theirs have the potential to be contaminated with Salmonella.
- Published
- February 15, 2017
- Distribution
- Georgia, Pennsylvania, and Alabama
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Franklin Farms East
- Product
- Buttermilk Solids FFE-8902: Lot # s 1608301-18, 42,650 poun…
- Reason
- Franklin Farms East & Meadow Mountain Nutritional have initiated a recall because several products of theirs have the potential to be contaminated with Salmonella.
- Published
- February 15, 2017
- Distribution
- Georgia, Pennsylvania, and Alabama
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dorothy Dawson Food Products dba Dawson Foods
- Product
- Dawson Foods Inc. Creamy White Frosting Mix , 5 Lb Bags, 6…
- Reason
- Dawson Food Products, Inc. initiated a voluntary recall of Creamy White Frosting Mix and Kustard Kwik Mix due to a supplier's recall of dried milk for potential contamination with Salmonella.
- Published
- February 15, 2017
- Distribution
- Domestic: GA, UT, WI Foreign:None VA…
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.
Read the full medical disclaimer.