Drugs & medicalClass II

Fagron Compounding Services recalls Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical…

Incorrect Product Formulation

Read the official notice →
Date
2025-12-17
Country
United States
Brand
Fagron Compounding Services
Product
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophthalmic Solution, 0.5mL Single-Use Syringe, For Topical…
Classification
Class II
Units
U.S. Nationwide.
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Fagron Compounding Services recalls

  1. 2026-04-15
  2. US
    Drugs & medicalClass II

    Fagron Compounding Services recalls Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS…

    Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

    FDA · DrugFagron Compounding ServicesNationwide in the U.S.A.Official notice →
  3. 2025-09-24
  4. US
  5. 2025-02-26
  6. US
  7. 2024-08-28
  8. US
  9. 2023-12-06
  10. US
    Drugs & medicalClass III

    Fagron Compounding Services recalls Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For…

    Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper

    FDA · DrugFagron Compounding ServicesNationwide in the USAOfficial notice →
All 6 Fagron Compounding Services recalls →

Other drugs & medical recalls in the United States

  1. 2025-12-17
  2. 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 →
  3. US
    Drugs & medicalClass III

    Winder Laboratories, LLC recalls Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories,…

    Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

    FDA · DrugWinder Laboratories, LLCU.S. NationwideOfficial notice →
  4. US
  5. US
    Drugs & medicalClass II

    Lupin Pharmaceuticals Inc. recalls Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for:…

    Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

    FDA · DrugLupin Pharmaceuticals Inc.FL, MA, MI & OHOfficial notice →
  6. US
    Drugs & medicalClass III

    Dr. Reddy's Laboratories, Inc. recalls Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC…

    Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

    FDA · DrugDr. Reddy's Laboratories, Inc.Distributed NationwideOfficial notice →
  7. 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 →
See all drugs & medical recalls →