Drugs & medicalClass II

Cipla Limited recalls Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule…

Failed Stability Specifications: Observed OOS results: eg results for colour index

Read the official notice →
Date
2025-12-10
Country
United States
Brand
Cipla
Product
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule…
Classification
Class II
Units
Nationwide in the USA
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Cipla recalls

  1. 2026-01-21
  2. US
  3. 2025-12-17
  4. US
    Drugs & medicalClass II

    Cipla USA, Inc. recalls Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard,…

    CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

    FDA · DrugCipla USA, Inc.Nationwide in the USOfficial notice →
  5. US
    Drugs & medicalClass II

    Cipla USA, Inc. recalls Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals,…

    Failed stability specifications: Out of specification for hardness test

    FDA · DrugCipla USA, Inc.Nationwide in the USAOfficial notice →
  6. 2025-08-27
  7. US
    Drugs & medicalClass III

    Cipla USA, Inc. recalls Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ,…

    Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.

    FDA · DrugCipla USA, Inc.U.S. Nationwide.Official notice →
  8. 2025-07-30
  9. US
    Drugs & medicalClass II

    Cipla USA, Inc. recalls Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd.…

    Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

    FDA · DrugCipla USA, Inc.Distributed Nationwide in the USAOfficial notice →
  10. 2024-11-20
  11. US
    Drugs & medicalClass II

    Cipla USA, Inc. recalls Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98

    Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

    FDA · DrugCipla USA, Inc.USA nationwide.Official notice →
All 20 Cipla recalls →

Other drugs & medical recalls in the United States

  1. 2025-12-10
  2. US
  3. US
    Drugs & medicalClass III

    Glenmark Pharmaceuticals Inc., USA recalls Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30;…

    Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

    FDA · DrugGlenmark Pharmaceuticals Inc., USANationwide in the USAOfficial notice →
  4. US
    Drugs & medicalClass III

    Teva Pharmaceuticals USA, Inc recalls Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis…

    Defective Container - A defect in the side-seal which allows leakage of product.

    FDA · DrugTeva Pharmaceuticals USA, IncU.S. NationwideOfficial notice →
  5. 2025-12-04
  6. US
    Drugs & medical

    KTEBO Writing Tablet Toys Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys; Sold on Amazon by KTEBO

    The recalled toys violate the mandatory standard for toys because the screw used to secure the battery compartment that contains a button cell battery does not remain attached as required. When button cell or coin…

    CPSCAbout 10,380Official notice →
  7. 2025-12-03
  8. US
    Drugs & medicalClass II

    Cepheid recalls Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.

    Product testing did not meet expected stability criteria.

    FDA · DeviceCepheidUS Nationwide distribution and Puerto Rico.Official notice →
  9. US
    Drugs & medicalClass II

    INTELERAD MEDICAL SYSTEMS INCORPORATED recalls IntelePACS - InteleConnect / TechPortal

    Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying…

    FDA · DeviceINTELERAD MEDICAL SYSTEMS INCORPORATEDUS Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN,…Official notice →
See all drugs & medical recalls →