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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 16821–16840 of 17,860 recalls

Class IITerminated

Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →
Class IITerminated

CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl Peroxide 5%) NDC 562032-113). Product under recall is the Pore Therapy (Salicylic Acid 2%), NDC 62032-110.

Medicis Pharmaceutical Corp

cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy

May 1, 2013 · Drug
View details →
Class ITerminated

Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ

Beamonstar Products

Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug

May 1, 2013 · DrugView details →
Class ITerminated

SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ

Beamonstar Products

Marketed Without an Approved NDA/ANDA; products have been found to contain tadalafil, the active ingredient in an FDA approved product used to treat erectile dysfunction, making this product an unapproved drug

May 1, 2013 · DrugView details →
Class IITerminated

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

King Legacy, a wholly owned subsidiary of Pfizer

Subpotent Drug: The products were below specification for potency at the expiry stability point.

April 30, 2013 · DrugView details →
Class IITerminated

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

King Legacy, a wholly owned subsidiary of Pfizer

Subpotent Drug: The products were below specification for potency at the expiry stability point.

April 30, 2013 · DrugView details →
Class IITerminated

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

King Legacy, a wholly owned subsidiary of Pfizer

Subpotent Drug: The products were below specification for potency at the expiry stability point.

April 30, 2013 · DrugView details →
Class IIITerminated

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16

Hi-Tech Pharmacal Co., Inc.

Subpotent; 24 month stability test station

April 30, 2013 · DrugView details →
Class IITerminated

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

King Legacy, a wholly owned subsidiary of Pfizer

Subpotent Drug: The products were below specification for potency at the expiry stability point.

April 30, 2013 · DrugView details →
Class IITerminated

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

King Legacy, a wholly owned subsidiary of Pfizer

Subpotent Drug: The products were below specification for potency at the expiry stability point.

April 30, 2013 · DrugView details →
Class IITerminated

DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32

Hospira Inc.

Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.

April 30, 2013 · DrugView details →
Class IITerminated

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

King Legacy, a wholly owned subsidiary of Pfizer

Subpotent Drug: The products were below specification for potency at the expiry stability point.

April 30, 2013 · DrugView details →
Class ITerminated

Vicerex A Powerful And Fast Acting Male Sexual Enhancer, 10 capsules per box, Dietary Supplement. UPC 893490820087 (product numbers may possibly vary for same product identification and same product packaging), distributed by Vicerex.com.

American Lifestyle.Com

Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.

April 30, 2013 · DrugView details →
Class IITerminated

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

King Legacy, a wholly owned subsidiary of Pfizer

Subpotent Drug: The products were below specification for potency at the expiry stability point.

April 30, 2013 · DrugView details →
Class IITerminated

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

King Legacy, a wholly owned subsidiary of Pfizer

Subpotent Drug: The products were below specification for potency at the expiry stability point.

April 30, 2013 · DrugView details →
Class IITerminated

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

King Legacy, a wholly owned subsidiary of Pfizer

Subpotent Drug: The products were below specification for potency at the expiry stability point.

April 30, 2013 · DrugView details →
Class IITerminated

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

King Legacy, a wholly owned subsidiary of Pfizer

Subpotent Drug: The products were below specification for potency at the expiry stability point.

April 30, 2013 · DrugView details →
Class ITerminated

Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on the front, the back side of the box contains mostly foreign character. Within the box there are four (4) capsules individually wrapped in black and red plastic with white lettering. UPC 4026666142546 (product numbers may possibly vary for same product identification and same product packaging).

American Lifestyle.Com

Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.

April 30, 2013 · DrugView details →
Class IITerminated

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

King Legacy, a wholly owned subsidiary of Pfizer

Subpotent Drug: The products were below specification for potency at the expiry stability point.

April 30, 2013 · DrugView details →
Class IIITerminated

Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)

Teva Pharmaceuticals USA, Inc.

Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.

April 26, 2013 · DrugView details →
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