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Drugs Recalls

17,897 recalls, newest first.

December 11, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmac
Hazard: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
December 11, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manu
Hazard: cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
December 11, 2024DrugsFDA
Midlab Incorporated recalls Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: 1 Gallon, 128 Ounces, 3.785 Liters, Royal
Hazard: cGMP Deviations: Out of specification results for micro in hand soap products.
December 11, 2024DrugsFDA
Midlab Incorporated recalls Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richar
Hazard: cGMP Deviations: Out of specification results for micro in hand soap products.
December 11, 2024DrugsFDA
Midlab Incorporated recalls ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 270
Hazard: cGMP Deviations: Out of specification results for micro in hand soap products.
December 11, 2024DrugsFDA
Midlab Incorporated recalls Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIV
Hazard: cGMP Deviations: Out of specification results for micro in hand soap products.
December 11, 2024DrugsFDA
Midlab Incorporated recalls boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L), Manufactured for Essendant Co., One Parkwa
Hazard: cGMP Deviations: Out of specification results for micro in hand soap products.
December 11, 2024DrugsFDA
Midlab Incorporated recalls MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallon (3.78 L), For Industrial and Institutiona
Hazard: cGMP Deviations: Out of specification results for micro in hand soap products.
December 11, 2024DrugsFDA
Boulla LLC recalls ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapm
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
December 11, 2024DrugsFDA
Boulla LLC recalls ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zo
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
December 11, 2024DrugsFDA
Boulla LLC recalls PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.Peak
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
December 11, 2024DrugsFDA
Boulla LLC recalls VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA
Hazard: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
December 11, 2024DrugsFDA
American Regent, Inc. recalls Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For In
Hazard: Presence of Particulate Matter: Potential for glass delamination from the vials.
December 11, 2024DrugsFDA
American Regent, Inc. recalls 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
Hazard: Presence of Particulate Matter: Potential for glass delamination from the vials.
December 11, 2024DrugsFDA
American Regent, Inc. recalls Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For In
Hazard: Presence of Particulate Matter: Potential for glass delamination from the vials.
December 11, 2024DrugsFDA
Aurobindo Pharma USA Inc recalls Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-
Hazard: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
December 11, 2024DrugsFDA
Aurobindo Pharma USA Inc recalls Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-8
Hazard: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
December 11, 2024DrugsFDA
Aurobindo Pharma USA Inc recalls Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-
Hazard: cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
December 11, 2024DrugsFDA
ACCORD HEALTHCARE, INC. recalls Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, I
Hazard: Subpotent drug
December 4, 2024DrugsFDA
JR Watkins recalls Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, O
Hazard: cGMP Deviations
December 4, 2024DrugsFDA
Neogen Corporation recalls LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Co
Hazard: CGMP violations.
December 4, 2024DrugsFDA
Neogen Corporation recalls LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Compa
Hazard: CGMP violations.
December 4, 2024DrugsFDA
Unexo Life Sciences Private Limited recalls PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Ph
Hazard: cGMP Deviations
December 4, 2024DrugsFDA
Unexo Life Sciences Private Limited recalls CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8
Hazard: cGMP Deviations
December 4, 2024DrugsFDA
Unexo Life Sciences Private Limited recalls JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA
Hazard: cGMP Deviations
December 4, 2024DrugsFDA
Unexo Life Sciences Private Limited recalls LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7
Hazard: cGMP Deviations
December 4, 2024DrugsFDA
Unexo Life Sciences Private Limited recalls EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOC
Hazard: cGMP Deviations
December 4, 2024DrugsFDA
Unexo Life Sciences Private Limited recalls HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LL
Hazard: cGMP Deviations
December 4, 2024DrugsFDA
Unexo Life Sciences Private Limited recalls THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, I
Hazard: cGMP Deviations
December 4, 2024DrugsFDA
Unexo Life Sciences Private Limited recalls THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 p
Hazard: cGMP Deviations