Checked
Food, Drug & Device Recalls in Colorado
FDA recalls whose distribution included Colorado, plus nationwide recalls. 1,287 in the last 12 months · Data as of 10/14/2026
Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.
Last 12 months
1,287
recall events
Class I
170
most serious, 12 mo.
Ongoing
4,701
still in progress
On record
17,135
56,190 products
Latest recalls
17,135 recall events · newest report first
- Class IIDrugOngoing10/14/2026Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro...Preferred Pharmaceuticals, Inc. · Failed Content Uniformity Specifications
- Class IIFoodOngoing10/14/202628 oz. Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange, and Gatorade Orange Zero.Pepsico Inc · Undeclared Yellow No. 6 and/or Yellow No. 5
- Class IIIDrugOngoing10/14/2026Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario...SUN PHARMACEUTICAL INDUSTRIES INC · 3 products · Failed Impurities/Degradation Specifications
- Class IIDrugOngoing10/14/2026Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans...Apothecary Pharma LLC · 2 products · Lack of Assurance of Sterility
- Class IIFoodOngoing10/14/2026Mezzetta GOLDEN GREEK PEPERONCINI MEDIUM HEAT 32 FL OZ G.L. MEZZETTA, INC., AMERICAN CANYON, NAPA VALLEY...G L Mezzetta Inc · Potential contamination with foreign objects: mice.
- Class IIDrugOngoing10/14/2026Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose...Cipla USA, Inc. · Failed Impurities/Degradation Specifications
- Class IFoodOngoing10/14/2026Berlin Seeds Alfalfa Sprouting Seeds, packaged in 1/4 lb., 1/2 lb., 1 lb., and 5 lb. resealable bags and...Berlin Seeds · Product contains alfalfa seed recalled by the supplier due to potential E. coli and/or Salmonella...
- Class IIDrugOngoing10/14/2026Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL)...K.C. Pharmaceuticals, Inc. · 8 products · Lack of Assurance of Sterility
- Class IFoodOngoing10/14/2026X10 Natural Enhancement Supplement, 0.5 fl oz/sachet (15 mL), 7 sachets/box, UPC: 7708075247094...A&P CREATIONS · 2 products · Product contains undeclared Sildenafil and Tadalafil.
- Class IIDrugOngoing10/14/2026TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on...Carolina Infusion, LLC · 16 products · Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing...
- Not Yet ClassifiedDrugOngoing10/14/2026Tri-Immune Boost (Glutathione: 200 mg, Ascorbic Acid: 200 mg, Zinc: 2.5 mg), 30 mL vial, Rx only, Centric...Centric Compounding LLC · Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial...
- Class IIMedical deviceOngoing10/14/2026HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing...Steris Corporation · A software issue may result in unintended mismatch of patient information on manually printed images....
- Class IIMedical deviceOngoing10/14/2026TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;LeMaitre Vascular, Inc. · Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon...
- Class IIIMedical deviceOngoing10/14/2026ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10AMindray DS USA, Inc. · 8 products · Certain monitor operator's manuals contain descriptions that may be insufficient or may require...
- Class IIMedical deviceOngoing10/14/2026Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System...Intellijoint Surgical, Inc. · A navigation system used to aid in selection and positioning of orthopedic implant system components has a...
- Class IIMedical deviceOngoing10/14/2026Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072...Medtronic MiniMed, Inc. · Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test...
- Class IIMedical deviceOngoing10/14/2026Alphenix INFX-8000C/B5Canon Medical System, USA, INC. · Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift...
- Class IIMedical deviceOngoing10/14/2026Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam...Safeguard US Operating LLC · Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the...
- Class IIMedical deviceOngoing10/14/2026HALYARD Laparoscopy Comprehensive Pack II REF: 49332GRI Medical & Electronic Technology Co., Ltd. · Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter
- Class IIMedical deviceOngoing10/14/2026Glypto Device, Glypto Cryo Machine;Limitless Cryo Spa LLC · Lack of 510(k) clearance.
- Class IIMedical deviceOngoing10/14/2026SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC · During use of an affected tube, the operator may encounter increased resistance when inserting the...
- Class IIMedical deviceOngoing10/14/2026DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;AVID Medical, Inc. · 15 products · Product may be potentially contaminated with a lubricant used during the manufacturing process.
- Class IIMedical deviceOngoing10/14/2026Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal frame intended...Medline Industries, LP · 2 products · The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork...
- Class IIMedical deviceOngoing10/14/2026DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU...Beckman Coulter Inc. · 2 products · Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma...
- Class IIMedical deviceOngoing10/14/2026Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);DRG International, Inc. · Potential for false negative patient results.
- Class IIMedical deviceOngoing10/14/2026Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside...PHILIPS MEDICAL SYSTEMS · Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in...
- Class IIMedical deviceOngoing10/14/2026VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006Steris Corporation · 6 products · Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life...
- Class IIMedical deviceOngoing10/14/2026Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04MOnkos Surgical, Inc. · 2 products · Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.
- Class IFoodOngoing10/14/2026Donutful Chocolate Dipped Vanilla Cake Donuts - 7.05oz/10ct.Case Configuration 5 count carton, 6 cartons...The Better Bakehouse Snack Company · Undeclared Milk.
- Class IIMedical deviceOngoing10/14/2026BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007Stryker Sustainability Solutions · Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side...
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Frequently asked questions
- What is the difference between Class I, II and III recalls?
- Class I is the most serious: the product could cause serious health problems or death. Class II may cause temporary or reversible health problems. Class III is unlikely to cause harm but breaks FDA rules.
- How do I know if my product is recalled?
- Open the recall and compare the product description, lot or code information and UPC with your package. If they match, stop using the product and follow the firm's instructions.
- Do these recalls affect Colorado?
- This list shows recalls whose distribution pattern named Colorado, plus recalls distributed nationwide. Products can still reach a state through online sales or resellers, so check any recall that matches your product.
- How often is this list updated?
- We check FDA enforcement reports every day. The FDA publishes new reports weekly, usually on Wednesdays.
Source: U.S. Food and Drug Administration, openFDA enforcement reports · Last updated 10/14/2026 · States are read from each recall's distribution text