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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 201–220 of 1,000 recalls

Class IIIOngoing

PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10,

Vivus, Inc.

Failed Stability Specifications

June 23, 2023 · DrugView details →
Class IIIOngoing

Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13

AVKARE LLC

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

June 13, 2023 · DrugView details →
Class IIITerminated

Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30

Amring Pharmaceuticals Inc

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

June 12, 2023 · DrugView details →
Class IIITerminated

GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3

HF Acquisition Co LLC

Labeling: Label Mix-up

June 6, 2023 · DrugView details →
Class IIITerminated

Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25

New England Life Care, Inc. dba Advanced Compounding Solutions

Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

May 22, 2023 · DrugView details →
Class IIITerminated

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

May 18, 2023 · DrugView details →
Class IIITerminated

Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Pharamceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1574-01.

Amneal Pharmaceuticals of New York, LLC

Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.

May 8, 2023 · DrugView details →
Class IIITerminated

Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28

Teva Pharmaceuticals USA Inc

Labeling: Incorrect or Missing Package Insert

April 27, 2023 · DrugView details →
Class IIITerminated

Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28

Teva Pharmaceuticals USA Inc

Labeling: Incorrect or Missing Package Insert

April 27, 2023 · DrugView details →
Class IIITerminated

Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28

Teva Pharmaceuticals USA Inc

Labeling: Incorrect or Missing Package Insert

April 27, 2023 · DrugView details →
Class IIITerminated

Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28

Teva Pharmaceuticals USA Inc

Labeling: Incorrect or Missing Package Insert

April 27, 2023 · DrugView details →
Class IIITerminated

Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28

Teva Pharmaceuticals USA Inc

Labeling: Incorrect or Missing Package Insert

April 27, 2023 · DrugView details →
Class IIITerminated

Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61

The Harvard Drug Group

Product mixup: one foreign tablet found in product.

April 24, 2023 · DrugView details →
Class IIIOngoing

Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch contains: 700 mg (50mg per gram adhesive) in an aqueous base, Manufactured by: Actavis Laboratories UT, Inc., Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 USA

Bryant Ranch Prepack, Inc.

Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.

April 20, 2023 · DrugView details →
Class IIITerminated

Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.

DuPont Nutrition USA, Inc

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

April 13, 2023 · DrugView details →
Class IIITerminated

Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.

DuPont Nutrition USA, Inc

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

April 13, 2023 · DrugView details →
Class IIITerminated

Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.

DuPont Nutrition USA, Inc

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

April 13, 2023 · DrugView details →
Class IIITerminated

Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.

DuPont Nutrition USA, Inc

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

April 13, 2023 · DrugView details →
Class IIITerminated

Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44

SCA Pharmaceuticals

Subpotent Drug: Out of specification results for low potency was obtained.

April 10, 2023 · DrugView details →
Class IIITerminated

Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08.

Accord Healthcare, Inc.

Sub-potent drug: assay test result below specifications at 9-month timepoint.

March 29, 2023 · DrugView details →
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