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Jul 14, 2026

Lupin recalls more than 2.5 million eye drops

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By: Justin Cooper
Fact checked by: Christine Klimanskis, ELS

Key takeaways:

  • Lupin Pharmaceuticals recalled bottles of prednisolone acetate eye drops.
  • The drops may have a “foreign substance,” potentially causing temporary or reversible adverse effects.

More than 2.5 million bottles of steroid eye drops aimed at relieving inflammation have been recalled, according to the FDA. Lupin Pharmaceuticals is recalling 2,530,182 bottles of prednisolone acetate ophthalmic solution 1%, including 5 mL, 10 mL and 15 mL bottles. The affected lots have expiration dates ranging from July 31, 2026, to March 31, 2028.

The stated reason for the recall is “presence of foreign substance.” The recall, issued on June 4, is class II, meaning the products could cause temporary or reversible adverse effects.

The affected drops were manufactured by Lupin Ltd. in Pithampur, India, and distributed throughout the U.S.

Earlier this year, more than 3 million eye drop bottles from K.C. Pharmaceuticals were recalled, spanning eight separate products. Lupin previously recalled eye drops used to treat bacterial conjunctivitis in 2019.

Read More: Lupin recalls more than 2.5 million eye drops

Source: Healio

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