drugs MODERATE Updated 2025-07-02

Apotex Corp. recalls Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Onl

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Recalled Product

Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4

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Hazard / Issue

Lack of Assurance of Sterility

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Batch VD1654, Exp Date: 06/30/2027

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall