Class III · Low risk Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus…
Reason Labeling: Not Elsewhere Classified - Wrong NDC number
FDA Drug Recalls
359 recalls, newest first
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08)…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited…
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2…
Reason CGMP Deviations: lack of adequate release testing.
Class II · Moderate risk Ongoing
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous…
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk Ongoing
Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For…
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk Ongoing
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous…
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk Ongoing
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC…
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc…
Reason Subpotent drug
Class II · Moderate risk Ongoing
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05)…
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05)…
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05)…
Reason cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal…
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co…
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701…
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY…
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkway North…
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutional Use…
Reason cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk Ongoing
Trinity Gold Nutrition, 60 Capsule, 30 day Supply, Distributed by Trinity Gold Nutrition 201 Tom Hall St. Ste. 2107, Fortmill, SC…
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac and phenylbutazone.
Class I · High risk Ongoing
ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.