Drugs & medicalClass II

Safecor Health, LLC recalls Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg…

Failed Stability Specifications

Read the official notice →
Date
2026-09-23
Country
United States
Brand
Safecor Health
Product
Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Safecor Health recalls

  1. 2026-05-27
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    Safecor Health, LLC recalls Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral…

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    Safecor Health, LLC recalls Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus,…

    Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

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  4. 2025-12-10
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    Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.

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  6. 2025-03-12
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    Safecor Health, LLC recalls Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster,…

    Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

    FDA · DrugSafecor Health, LLCNationwide in the USAOfficial notice →
  8. 2024-11-27
  9. US
    Drugs & medicalClass II

    Safecor Health, LLC recalls Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01

    cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

    FDA · DrugSafecor Health, LLCUSA nationwide.Official notice →
  10. 2023-11-08
  11. US
    Drugs & medicalClass II

    Safecor Health, LLC recalls Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA…

    CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.

    FDA · DrugSafecor Health, LLCDistributed Nationwide in the USAOfficial notice →
All 7 Safecor Health recalls →

Other drugs & medical recalls in the United States

  1. 2026-09-23
  2. US
  3. US
  4. US
    Drugs & medicalClass II

    SUN PHARMA /TARO recalls Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada,…

    Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

    FDA · DrugSUN PHARMA /TARONationwide in the USAOfficial notice →
  5. 2026-09-16
  6. US
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    Windstone Medical Packaging, Inc. recalls AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B

    The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.

    FDA · DeviceWindstone Medical Packaging, Inc.US Nationwide distribution in the states of CA, GA, WA.Official notice →
  7. US
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    Nipro Renal Soultions USA, Corporation recalls MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201

    Hemodialysis concentrates contain high endotoxin levels

    FDA · DeviceNipro Renal Soultions USA, CorporationWorldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI,…Official notice →
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See all drugs & medical recalls →