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Safety · Official FDA Data
Recent prescription and over-the-counter drug recalls reported to the FDA, including contamination, mislabeling, and potency problems.
Safecor Health, LLC
Product: Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01
Reason: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
FDA recall #D-0538-2026 · Ongoing
IntegraDose Compounding Services LLC
Product: fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1.
Reason: Subpotent Drug
FDA recall #D-0548-2026 · Ongoing
Zydus Pharmaceuticals (USA) Inc
Product: Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).
Reason: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
FDA recall #D-0545-2026 · Ongoing
Lupin Pharmaceuticals Inc.
Product: Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.
Reason: Presence of particulate matter: a white thread-like structure in the cartridge
FDA recall #D-0541-2026 · Ongoing
Zydus Pharmaceuticals (USA) Inc
Product: Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).
Reason: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
FDA recall #D-0544-2026 · Ongoing
Amerisource Health Services LLC
Product: Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA recall #D-0537-2026 · Ongoing
Golden State Medical Supply Inc.
Product: Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA recall #D-0534-2026 · Ongoing
Golden State Medical Supply Inc.
Product: Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA recall #D-0535-2026 · Ongoing
Wisconsin Pharmacal Company
Product: MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037.
Reason: Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
FDA recall #D-0553-2026 · Ongoing
UCB Biosciences Inc.
Product: 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 cartons, STARTER KIT, NDC 50474-710-81.
Reason: Lack of Assurance of Sterility
FDA recall #D-0546-2026 · Ongoing
Amerisource Health Services LLC
Product: Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA recall #D-0536-2026 · Ongoing
ANI Pharmaceuticals, Inc.
Product: Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
Reason: Defective Container; packets were found to be either empty or partially full.
FDA recall #D-0543-2026 · Ongoing
Sagent Pharmaceuticals
Product: Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.
Reason: Failed Impurities/Degradation Specifications
FDA recall #D-0539-2026 · Ongoing
Lannett Company Inc.
Product: Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
FDA recall #D-0533-2026 · Ongoing
Haleon US Holdings LLC
Product: Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Reason: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
FDA recall #D-0542-2026 · Ongoing
Safecor Health, LLC
Product: Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08
Reason: Presence of a Foreign Substance; black particles observed in liquid
FDA recall #D-0549-2026 · Ongoing
Oasis Medical, Inc.
Product: 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 42126-6400-1.
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.
FDA recall #D-0525-2026 · Ongoing
ENDO USA, Inc.
Product: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manufactured for: Endo USA, Malvern, PA 19855, NDC 42023-179-05.
Reason: Presence of particulate matter: identified as Buprenorphine free base
FDA recall #D-0527-2026 · Ongoing
Ascend Laboratories, LLC
Product: Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.
Reason: Failed Dissolution Specifications
FDA recall #D-0547-2026 · Ongoing
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
Product: TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670
Reason: Incorrect Product Formulation: product did not contain insulin as listed in the label.
FDA recall #D-0524-2026 · Ongoing
CareFusion 213, LLC
Product: 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, subsidary of Becton Dickinson and Co. NDC 54365-014-41
Reason: Lack of assurance of Sterility: potential product contamination
FDA recall #D-0518-2026 · Ongoing
CareFusion 213, LLC
Product: 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
FDA recall #D-0517-2026 · Ongoing
Ajanta Pharma Ltd.
Product: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India
Reason: 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.
FDA recall #D-0514-2026 · Ongoing
Acella Pharmaceuticals, LLC
Product: 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
Reason: Chemical contamination; presence of lead and lithium above specification
FDA recall #D-0523-2026 · Ongoing
JB Chemicals and Pharmaceuticals Ltd
Product: Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
Reason: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
FDA recall #D-0520-2026 · Ongoing
Ajanta Pharma Ltd.
Product: Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
Reason: 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.
FDA recall #D-0516-2026 · Ongoing
Unichem Pharmaceuticals USA Inc.
Product: busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
Reason: Subpotent drug
FDA recall #D-0511-2026 · Ongoing
Breckenridge Pharmaceutical, Inc.
Product: 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.
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
FDA recall #D-0522-2026 · Ongoing
B BRAUN MEDICAL INC
Product: Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
Reason: Presence of Particulate Matter.
FDA recall #D-0540-2026 · Ongoing
Fresenius Medical Care Holdings, Inc.
Product: 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.
Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
FDA recall #D-0513-2026 · Ongoing
Teva Pharmaceuticals USA, Inc
Product: 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 vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.
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.
FDA recall #D-0519-2026 · Ongoing
Fresenius Medical Care Holdings, Inc.
Product: 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.
Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
FDA recall #D-0512-2026 · Ongoing
Ajanta Pharma Ltd.
Product: Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
Reason: 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.
FDA recall #D-0515-2026 · Ongoing
Thea Pharma, Inc.
Product: 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.
FDA recall #D-0501-2026 · Ongoing
Wells Pharma of Houston LLC
Product: Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Reason: cGMP deviations.
FDA recall #D-0507-2026 · Ongoing
Thea Pharma, Inc.
Product: 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.
FDA recall #D-0500-2026 · Ongoing
Wells Pharma of Houston LLC
Product: fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
Reason: cGMP deviations.
FDA recall #D-0506-2026 · Ongoing
Wells Pharma of Houston LLC
Product: fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
Reason: cGMP deviations.
FDA recall #D-0504-2026 · Ongoing
Alcon Research LLC
Product: 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.
Reason: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
FDA recall #D-0492-2026 · Ongoing
Hikma Pharmaceuticals USA INC
Product: 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.
Reason: This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
FDA recall #D-0526-2026 · Ongoing
Data source: U.S. Food & Drug Administration (FDA) — openFDA enforcement API. See our methodology.