cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 ca...
Reason: Lack of Assurance of Sterility
D-0546-2026May 27, 2026Smyrna, GA
Oasis Medical, Inc.
Class IIOngoing
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6...
Reason: Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
D-0525-2026May 20, 2026Glendora, CA
Fresenius Medical Care Holdings, Inc.
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 Ame...
Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
D-0512-2026May 13, 2026Waltham, MA
CareFusion 213, LLC
Class IIOngoing
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912...
Reason: Lack of assurance of Sterility: potential product contamination
D-0518-2026May 13, 2026El Paso, TX
CareFusion 213, LLC
Class IIOngoing
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42...
Reason: Lack of assurance of Sterility: potential product contamination
D-0517-2026May 13, 2026El Paso, TX
Fresenius Medical Care Holdings, Inc.
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 Amer...
Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
D-0513-2026May 13, 2026Waltham, MA
Teva Pharmaceuticals USA, Inc
Class IIOngoing
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vi...
Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
D-0519-2026May 13, 2026Parsippany, NJ
Thea Pharma, Inc.
Class IIOngoing
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11
Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
D-0501-2026May 6, 2026Waltham, MA
Thea Pharma, Inc.
Class IIOngoing
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11
Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Reason: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
D-0492-2026May 6, 2026Fort Worth, TX
SCOPE HEALTH
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.
Reason: Lack of Assurance of Sterility
D-0499-2026May 6, 2026New York, NY
Alcon Research LLC
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
Reason: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
D-0491-2026May 6, 2026Fort Worth, TX
B BRAUN MEDICAL INC
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.
Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
D-0495-2026April 29, 2026Allentown, PA
Harrow Eye LLC
Class IIOngoing
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Reason: Lack of Assurance of Sterility
D-0489-2026April 29, 2026Nashville, TN
B BRAUN MEDICAL INC
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.
Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
D-0496-2026April 29, 2026Allentown, PA
B BRAUN MEDICAL INC
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.
Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
D-0498-2026April 29, 2026Allentown, PA
B BRAUN MEDICAL INC
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.
Reason: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
D-0497-2026April 29, 2026Allentown, PA
Huons Co., Ltd.
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 cart...
Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR
Reason: Lack of Assurance of Sterility
D-0471-2026April 22, 2026Beaverton, OR
International Medication Systems Ltd.
Class IIOngoing
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1
Reason: Lack of Assurance of Sterility
D-0483-2026April 22, 2026South El Monte, CA
Huons Co., Ltd.
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, ...
Reason: Lack of Assurance of Sterility
D-0531-2026April 22, 2026Jecheon, N/A
Huons Co., Ltd.
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...
Reason: Lack of Assurance of Sterility
D-0530-2026April 22, 2026Jecheon, N/A
Fresenius Kabi USA, LLC
Class IIOngoing
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale...
Reason: Lack of Assurance of Sterility
D-0425-2026April 15, 2026Lake Zurich, IL
Fresenius Kabi USA, LLC
Class IIOngoing
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"...