FDA Recalls USDA Recalls About

FDA Recalls

Food recalls
Drug recalls
Device recalls

USDA Recalls

All USDA recalls
Poultry recalls
Meat recalls
Egg recalls

About

About us
FDA guides
USDA guides
Data sources
Privacy policy

Data

OpenFDA API
USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

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 141–160 of 679 recalls

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

TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01

Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

April 8, 2026 · DrugView details →

Class IIOngoing

Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show Spray (isopropyl Alcohol, D-Limonene, Undecylenic Acid). Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670, Manufactured for Doctor's Inc

Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

April 8, 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

TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.

Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

April 8, 2026 · DrugView details →

Class IIOngoing

Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,

Blaine Labs Inc

CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

April 8, 2026 · DrugView details →

Class IIOngoing

vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.

Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

April 8, 2026 · DrugView details →

Class IIOngoing

TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01.

Blaine Labs Inc

CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated

April 8, 2026 · DrugView details →

Class IIOngoing

TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01.

Blaine Labs Inc

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

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 →

← PreviousPage 8 of 34Next →