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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 21–40 of 618 recalls

Class IIOngoing

GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.

Alcon Research LLC

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

April 21, 2026 · DrugView details →

Class IIOngoing

Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.

Breckenridge Pharmaceutical, Inc.

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

April 21, 2026 · DrugView details →

Class IIOngoing

Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01

Alcon Research LLC

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

April 21, 2026 · DrugView details →

Class IIOngoing

NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16

Acella Pharmaceuticals, LLC

Chemical contamination; presence of lead and lithium above specification

April 20, 2026 · DrugView details →

Class IIOngoing

Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01.

SCOPE HEALTH

Lack of Assurance of Sterility

April 20, 2026 · DrugView details →

Class IIOngoing

FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.

Harrow Eye LLC

Lack of Assurance of Sterility

April 17, 2026 · DrugView details →

Class IIOngoing

Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06

The Harvard Drug Group LLC

Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

April 9, 2026 · DrugView details →

Class IIOngoing

Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses), Rx only, Mfg by: Apotek inc., Toronto, Ontario, Canada, M9L 1T9, Mfg for: Apotek Corp., Weston, FL 33326, NDC 60505-0815-0

Apotex Corp.

Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.

April 8, 2026 · DrugView details →

Class IIOngoing

Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.

Hikma Pharmaceuticals USA INC

This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

April 7, 2026 · DrugView details →

Class IIOngoing

Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

Teva Pharmaceuticals USA, Inc

Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

April 6, 2026 · DrugView details →

Class IIOngoing

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.

Fresenius Medical Care Holdings, Inc.

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

April 6, 2026 · DrugView details →

Class IIOngoing

DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.

Fresenius Medical Care Holdings, Inc.

Lack of Assurance of Sterility: Potential leaks from perforations in bags.

April 6, 2026 · DrugView details →

Class IIOngoing

DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.

B BRAUN MEDICAL INC

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

April 2, 2026 · DrugView details →

Class IIOngoing

LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.

B BRAUN MEDICAL INC

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

April 2, 2026 · DrugView details →

Class IIOngoing

0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.

Huons Co., Ltd.

Lack of Assurance of Sterility

April 2, 2026 · DrugView details →

Class IIOngoing

Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)

Huons Co., Ltd.

Lack of Assurance of Sterility

April 2, 2026 · DrugView details →

Class IIOngoing

0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.

B BRAUN MEDICAL INC

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

April 2, 2026 · DrugView details →

Class IIOngoing

Lidocaine HCl injection, USP, 1% 50mg/5mL (10 mg/mL), 5 mL Single Dose Vials, Rx only, Manufactured by: Huons Co, Ltd, Chungcheongbuk-do, Korea NDC 73293-0001-1 (vial), NDC 73293-0001-2 (10 count carton); Distributed by: McKesson Corporation, dba Sky Packaging, NDC 63739-170-13 (vials), NDC 63739-170-24 (10 count cartons) and NDC 63739-170-27 (25 count cartons); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 71351-021-05 (vials), NDC 71351-021-10 (10 count cartons), NDC 71351-021-25 (25 count cartons); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0001-1 (vials), NDC 84769-0001-2 (10 count carton)

Huons Co., Ltd.

Lack of Assurance of Sterility

April 2, 2026 · DrugView details →

Class IIOngoing

Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.

B BRAUN MEDICAL INC

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

April 2, 2026 · DrugView details →

Class IIOngoing

Lidocaine HCl Injection, USP, 2%, 100 mg/5mL (20 mg/mL), 5 mL Single-Dose Vials, Rx only, Manufactured by: Huons Co., Ltd., 100 Bio valley-ro, Jecheon-si, Chungchengbuk-do, Korea, NDC 73293-0003-1 (vial), NDC 73293-0003-2 (10 count carton); Distributed by: Brookefield Pharmaceuticals, LLC, Brookefield, WI, NDC 71351-023-05 (vials), NDC 71351-023-10 (10 count cartons), NDC 71351-023-25 (25 count cartons); Manufactured for: Precision Dose Inc, South Beloit IL NDC 68094-081-01 (vial), NDC 68094-081-25 (25 count carton); Distributed by Novagenix Labs LLC, Morrisville, NC NDC 84769-0002-1 (vials), NDC 84769-0002-2 (10 count carton)

Huons Co., Ltd.

Lack of Assurance of Sterility

April 2, 2026 · DrugView details →

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