FDA Recall
TerminatedTerminated: February 26, 2014Historical recordClass II
Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.
by Sandoz Incorporated
- Reason
- Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
- Published
- May 1, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 14, 2013Historical recordClass I
WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD 57013. Manufactured by Riger Natural, S. A. Mexico.
by Brower Enterprises Inc
- Reason
- Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac.
- Published
- May 1, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 5, 2013Historical recordClass I
Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA
by Body Basics Inc
- Reason
- Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 11, 2013Historical recordClass III
Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.
by Lupin Pharmaceuticals Inc.
- Reason
- Discoloration; Product may not meet specifications for color description once reconstituted.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 21, 2015Historical recordClass I
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.
by Hospira Inc.
- Reason
- Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 21, 2015Historical recordClass I
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA; NDC 0409-7929-09.
by Hospira Inc.
- Reason
- Non-Sterility: Confirmed customer complaint of product contaminated with mold.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened..
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles ( NDC 60793-853-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened..
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles ( NDC 60793-852-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles ( NDC 60793-851-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
CompletedHistorical recordClass II
Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.
by Pfizer Inc.
- Reason
- Chemical contamination: emission of strong odor after package was opened..
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 7, 2015Historical recordClass II
Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.
by Precision Dose Inc.
- Reason
- Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 5, 2013Historical recordClass II
Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131; Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30
by Teva Pharmaceuticals USA, Inc.
- Reason
- Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
- Published
- April 24, 2013
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 9, 2014Historical recordClass III
buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217; NDC 67767-142-30.
by Actavis South Atlantic LLC
- Reason
- Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
- Published
- April 24, 2013
- 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.
Read the full medical disclaimer.