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© 2026Civic Data · Data sourced from OpenFDA, updated weekly · Not affiliated with the U.S. Food and Drug Administration · Always verify against official FDA sources before acting

  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 81–100 of 436 recalls

Class IICompleted

Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

Baxter Healthcare Corporation

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

March 15, 2023 · DrugView details →
Class IICompleted

Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 10 mL dropper bottle NDC 60505-0564-2, UPC 3 60505 05642 2; c) 15 mL dropper bottle, NDC 60505-0564-3, UPC 3 60505 05643 9; Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326

Apotex Corp.

Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.

March 1, 2023 · DrugView details →
Class IICompleted

0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10

B. Braun Medical Inc.

Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.

February 10, 2023 · DrugView details →
Class IICompleted

0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00

B. Braun Medical Inc.

Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.

February 10, 2023 · DrugView details →
Class IICompleted

Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,

Pfizer Inc.

Lack of assurance of sterility: Bags have the potential to leak.

December 29, 2022 · DrugView details →
Class IICompleted

Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15

AVKARE LLC

Failed impurities/degradation specifications: Out of specification for unknown impurities.

December 22, 2022 · DrugView details →
Class IICompleted

Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062

NCH Life Sciences LLC

CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.

December 9, 2022 · DrugView details →
Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →
Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →
Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →
Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →
Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →
Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →
Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →
Class IICompleted

Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90

Aurobindo Pharma USA Inc.

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

October 5, 2022 · DrugView details →
Class IICompleted

Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7

Ingenus Pharmaceuticals Llc

Out of specification for related substances (impurities).

September 30, 2022 · DrugView details →
Class IICompleted

Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.

AuroMedics Pharma LLC

Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.

September 26, 2022 · DrugView details →
Class IIICompleted

Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16

Dr. Reddy's Laboratories, Inc.

Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

September 14, 2022 · DrugView details →
Class IICompleted

Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.

Direct Rx

CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.

September 12, 2022 · DrugView details →
Class IICompleted

MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion

Lack of Assurance of Sterility

August 26, 2022 · DrugView details →
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