FDA Enforcement · May 13, 2026
Food recall: LUNDBERG FAMILY FAMRS WHITE RICE JASMINE NET WT 32 OZ (2 lb) 907 g Manufactured and Distributed by:…
Potential contamination with foreign materials. — Wehah Farms · Class II · Ongoing
Recalls & Safety · page 54
Recalls and safety alerts from the FDA, newest first.
FDA Enforcement · May 13, 2026
Food recall: Bulk WN-976-782-1 Seasoning for Cheese Sauce, Net Wt. 43.50 lbs., in a brown kraft bag
Product has the potential to be contaminated with Salmonella. — Givaudan Flavors Corp · Class I · Ongoing
FDA Enforcement · May 13, 2026
Food recall: Fain s Blackberry Honey Spread, 12oz net wt., UPC 01832213862
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic. — Walker Honey Co · Class II · Ongoing
FDA Enforcement · May 13, 2026
Food recall: Loard's Champagne Sherbert - 32 oz
Undeclared Milk, Red #40. — Silver Moon LP dba Loard's Ice Cream · Class II · Ongoing
FDA Enforcement · May 13, 2026
Food recall: Low Heat Non-Fat Dried Milk Powder - plastic totes (NTE) 2200 lbs. (packed under 5 labels: Off Grade NFDM…
Potential contamination with Salmonella. — California Dairies Inc. · Class I · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France,…
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. — Thea Pharma, Inc. · Class II · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive,…
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by:…
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. — Thea Pharma, Inc. · Class II · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma…
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per…
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc.,…
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. — Alcon Research LLC · Class II · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by:…
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. — Hikma Pharmaceuticals USA INC · Class II · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells…
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope…
Lack of Assurance of Sterility — SCOPE HEALTH · Class II · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of…
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g),…
Failed PH Specifications — Water-Jel Technologies, LLC · Class III · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon…
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. — Alcon Research LLC · Class II · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only,…
Labeling: Missing Label — American Regent, Inc. · Class III · Ongoing
FDA Enforcement · May 6, 2026
Drug recall: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma,…
cGMP deviations. — Wells Pharma of Houston LLC · Class II · Ongoing
FDA Enforcement · Apr 29, 2026
Drug recall: Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per…
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. — The Harvard Drug Group LLC · Class II · Ongoing
FDA Enforcement · Apr 29, 2026
Drug recall: FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA.
Lack of Assurance of Sterility — Harrow Eye LLC · Class II · Ongoing
FDA Enforcement · Apr 29, 2026
Drug recall: DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA…
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. — B BRAUN MEDICAL INC · Class II · Ongoing
FDA Enforcement · Apr 29, 2026
Drug recall: Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC,…
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. — Leading Pharma, LLC · Class II · Ongoing