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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 101–120 of 1,000 recalls

Class IIITerminated

Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10

Lannett Company Inc.

Failed Impurity/Degradation Specifications

November 9, 2022 · DrugView details →
Class IIITerminated

Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990.

Genentech Inc

Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.

October 18, 2022 · Drug
View details →
Class IIITerminated

Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound), 100 mg per vial, NDC 80803-153-50, manufactured for Aadi Bioscience, Inc, CA.

Aadi Bioscience

Failed Stability Specifications

October 13, 2022 · DrugView details →
Class IIITerminated

NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com

LNK International, Inc.

Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg

October 11, 2022 · DrugView details →
Class IIITerminated

oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.

QuVa Pharma, Inc.

Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).

September 20, 2022 · DrugView details →
Class IIITerminated

Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01

UNICHEM PHARMACEUTICALS USA INC

Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,

September 19, 2022 · DrugView details →
Class IIITerminated

Xolegel (ketoconazole) gel 2%, 45 gram tubes, Rx only, Manufactured by: DPT Laboratories, San Antonio, TX 78215, NDC 16110-080-45

ALMIRALL, LLC

Failed Viscosity specification: Slightly higher OOS results obtained for viscosity

September 16, 2022 · DrugView details →
Class IIITerminated

Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S, 800-323-2251, Made in USA, NDC 11429-1010-8

Woodbine Products Co Inc

Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.

August 30, 2022 · DrugView details →
Class IIITerminated

ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01

Leading Pharma, LLC

Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

August 23, 2022 · DrugView details →
Class IIITerminated

Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.

LNK International, Inc.

Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.

August 4, 2022 · DrugView details →
Class IIITerminated

Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ

Akron Pharma, Inc.

Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

August 4, 2022 · DrugView details →
Class IIITerminated

Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ

Akron Pharma, Inc.

Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.

August 4, 2022 · DrugView details →
Class IIITerminated

Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02

HERON THERAPEUTICS, INC.

Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit

August 2, 2022 · DrugView details →
Class IIITerminated

Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56

Amerisource Health Services LLC

Subpotent Drug

July 27, 2022 · DrugView details →
Class IIITerminated

Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56

Teva Pharmaceuticals USA Inc

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

July 22, 2022 · DrugView details →
Class IIITerminated

Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4

AVKARE Inc.

Labeling: Label Error on Declared Strength

July 20, 2022 · DrugView details →
Class IIITerminated

Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566

Eco Lips, Inc

Failed Dissolution Specifications

June 29, 2022 · DrugView details →
Class IIITerminated

Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566

Eco Lips, Inc

Failed Dissolution Specifications

June 29, 2022 · DrugView details →
Class IIITerminated

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.

SUN PHARMACEUTICAL INDUSTRIES INC

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

June 21, 2022 · DrugView details →
Class IIITerminated

Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.

SUN PHARMACEUTICAL INDUSTRIES INC

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

June 21, 2022 · DrugView details →
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