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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 241–260 of 623 recalls

Class IIOngoing

Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →
Class IIOngoing

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Boston, 55 6th Rd Woburn, Massachusetts 01801-1767.

Central Admixture Pharmacy Services, Inc.

Incorrect product formulation: bag did not contain copper and famotidine per label.

June 2, 2026 · DrugView details →
Class IIOngoing

Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 3 66715 97310 8.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →
Class IIOngoing

Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →
Class IIOngoing

Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30255 8.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →
Class IIOngoing

Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 1 94283 65181 0.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →
Class IIOngoing

Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →
Class IIOngoing

Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4.

Dabur India Limited

CGMP Deviations; deficiencies observed during FDA inspection

June 2, 2026 · DrugView details →
Class IIOngoing

Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30

Ascend Laboratories, LLC

Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis

June 1, 2026 · DrugView details →
Class IIOngoing

Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49.

SUN PHARMACEUTICAL INDUSTRIES INC

Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution

May 29, 2026 · DrugView details →
Class IIOngoing

Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA

Gasco Industrial Corp.

Subpotent drug

May 29, 2026 · DrugView details →
Class IIOngoing

Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.

Gasco Industrial Corp.

Subpotent drug

May 29, 2026 · DrugView details →
Class IIOngoing

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567.

Gasco Industrial Corp.

Subpotent drug

May 29, 2026 · DrugView details →
Class IIOngoing

Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3

Gasco Industrial Corp.

Subpotent drug

May 29, 2026 · DrugView details →
Class IIOngoing

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924

Gasco Industrial Corp.

Subpotent drug

May 29, 2026 · DrugView details →
Class IIOngoing

Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529

Gasco Industrial Corp.

Subpotent drug

May 29, 2026 · DrugView details →
Class IIOngoing

GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90.

Golden State Medical Supply Inc.

Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.

May 29, 2026 · DrugView details →
Class IIOngoing

HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.

Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

May 28, 2026 · DrugView details →
Class IIOngoing

HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5.

Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

May 28, 2026 · DrugView details →
Class IIOngoing

CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80.

Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

May 28, 2026 · DrugView details →
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