FDA Recall
Terminated
Historical recordClass II
glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10
by Mylan Pharmaceuticals Inc.
- Reason
- Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
- Published
- March 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25
by Amerisource Health Services
- Reason
- Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
- Published
- March 8, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The Kroger Co
- Product
- Fred Meyer 100% Whole Wheat Bread 16 oz plastic bag DISTRIB…
- Reason
- During an internal investigationi at the manufacturing facility the firm discovered that hte product may contain undeclared undeclared milk.
- Published
- March 8, 2017
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
World Organic Corp.
- Product
- Theravits 100, container sizes: 30, 60, 90, 180, Product Cod…
- Reason
- World Organic Corporation dba Licata Enterprise is recalling multiple vitamins because it contains fish liver oil that is declared on the product label; however, the label also states "Contains NO...common allergens." The product also contains the following dietary ingredients that are missing from the label: molybdenum, pancreatin, diastase, papain, ox bile, vanadium, silicon, boron and bromelain.
- Published
- March 8, 2017
- Distribution
- US: WY, TX, VA, UT, ID, WA, OR, CA, OH,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fred Meyers Inc
- Product
- Bakery Fresh Goodness Carrot Cupcakes sold in 6 ct. 12 ct. a…
- Reason
- Bakery Fresh Goodness Carrot Cupcakes are recalled due to undeclared milk and soy.
- Published
- March 8, 2017
- Distribution
- distributed in Alaska, Idaho, Oregon, an…
View recall →
FDA Recall
Terminated
Historical recordClass III
Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, and 2 Suction Oral Swab packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, Rx only, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013, Reorder #6306, UPC 6 18029 83041 8.
by Sage Products Inc
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.
- Published
- March 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540.
by Sandoz Inc
- Reason
- Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.
- Published
- March 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24
by Hospira Inc., A Pfizer Company
- Reason
- Lack of Sterility Assurance: customer report of leaking bag
- Published
- March 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0
by Apotex Inc.
- Reason
- Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.
- Published
- March 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
True World Foods Portland, LLC
- Product
- Ogo (Seaweed) packaged in plastic bags. Label contains th…
- Reason
- True World Foods Portland, LLC received, repackaged and distributed Ogo (seaweed) which was recalled from the raw material supplier of the Ogo (or Limu) because it was harvested from the farm that has been linked to Salmonella illnesses in the state of Hawaii.
- Published
- March 1, 2017
- Distribution
- Restaurants in Portland, OR only
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Falafel King Ent, Inc.
- Product
- Falafel King Tzatziki Sauce. 10 ounce. Plastic container
- Reason
- Falafel King announced a recall for their Tzatziki Sauce due to undeclared milk on product label.
- Published
- March 1, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Hostess Brands, LLC
- Product
- Holiday White Peppermint Hostess Twinkies, cream-filled snac…
- Reason
- Product contains an ingredient that was recalled by a supplier because it may be contaminated with Salmonella.
- Published
- March 1, 2017
- Distribution
- Nationwide
View recall →
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
Bwi Inc
- Product
- Burts British Hand Cooked Potato Chips Sea Salt & Malted Vi…
- Reason
- Product is labeled as gluten free; however was labeled as containing an ingredient with gluten.
- Published
- February 22, 2017
- Distribution
- U.S. distribution to the following; MA,…
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 →
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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