May 13, 2026DrugsFDA
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Marto
Hazard: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
May 13, 2026DrugsFDA
JB Chemicals and Pharmaceuticals Ltd recalls Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories
Hazard: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
May 13, 2026DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL
Hazard: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
May 13, 2026DrugsFDA
CareFusion 213, LLC recalls BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl
Hazard: Lack of assurance of Sterility: potential product contamination
May 13, 2026DrugsFDA
CareFusion 213, LLC recalls BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL
Hazard: Lack of assurance of Sterility: potential product contamination
May 13, 2026DrugsFDA
Ajanta Pharma Ltd. recalls Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0
Hazard: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
May 13, 2026DrugsFDA
Ajanta Pharma Ltd. recalls Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 0
Hazard: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
May 13, 2026DrugsFDA
Ajanta Pharma Ltd. recalls Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03,
Hazard: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
May 13, 2026DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2
Hazard: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
May 13, 2026DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only,
Hazard: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
May 13, 2026DrugsFDA
Unichem Pharmaceuticals USA Inc. recalls busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, A
Hazard: Subpotent drug
May 6, 2026DrugsFDA
Hikma Pharmaceuticals USA INC recalls Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceu
Hazard: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
May 6, 2026DrugsFDA
Water-Jel Technologies, LLC recalls Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2%), NET WT 0.5 OZ (14 g), Distributed by
Hazard: Failed PH Specifications
May 6, 2026DrugsFDA
Wells Pharma of Houston LLC recalls fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15
Hazard: cGMP deviations.
May 6, 2026DrugsFDA
Wells Pharma of Houston LLC recalls Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054,
Hazard: cGMP deviations.
May 6, 2026DrugsFDA
Wells Pharma of Houston LLC recalls fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC
Hazard: cGMP deviations.
May 6, 2026DrugsFDA
Wells Pharma of Houston LLC recalls fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells pharma of Houston, NDC
Hazard: cGMP deviations.
May 6, 2026DrugsFDA
Wells Pharma of Houston LLC recalls fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag,
Hazard: cGMP deviations.
May 6, 2026DrugsFDA
Wells Pharma of Houston LLC recalls fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, Wells Pharma in Housto
Hazard: cGMP deviations.
May 6, 2026DrugsFDA
Wells Pharma of Houston LLC recalls Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
Hazard: cGMP deviations.
May 6, 2026DrugsFDA
Thea Pharma, Inc. recalls Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea
Hazard: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
May 6, 2026DrugsFDA
Thea Pharma, Inc. recalls iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc
Hazard: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
May 6, 2026DrugsFDA
SCOPE HEALTH recalls Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Ma
Hazard: Lack of Assurance of Sterility
May 6, 2026DrugsFDA
American Regent, Inc. recalls Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent
Hazard: Labeling: Missing Label
May 6, 2026DrugsFDA
Alcon Research LLC recalls GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas
Hazard: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
May 6, 2026DrugsFDA
Alcon Research LLC recalls Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort W
Hazard: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
April 29, 2026DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs
Hazard: Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
April 29, 2026DrugsFDA
B BRAUN MEDICAL INC recalls LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC:
Hazard: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
April 29, 2026DrugsFDA
B BRAUN MEDICAL INC recalls 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524,
Hazard: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
April 29, 2026DrugsFDA
B BRAUN MEDICAL INC recalls DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC:
Hazard: Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.