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2.5 Million Bottles of Eye Drops Recalled Nationwide, FDA Warns

The FDA said the Class II recall covers 2,530,182 bottles and warns the drops may contain a foreign substance.

  • On July 9, 2026, The FDA reported the recall of over 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension nationwide due to the potential presence of a foreign substance.
  • Manufacturer Lupin Pharmaceuticals initiated the recall on June 4, which The FDA classified as a Class II recall on June 30.
  • Recalled items are labeled as "prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile." According to Mayo Clinic, this steroid medicine relieves eye redness, itching, and swelling.
  • The FDA advises individuals to immediately stop using any recalled products, while manufacturers should notify customers about the recall and provide disposal instructions.
  • Dozens of lot codes were impacted across 5 mL, 10 mL, and 15 mL bottles. No illness history associated with the product is currently available.
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PHL17 broke the news on Thursday, July 9, 2026.
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