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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Rising Pharmaceuticals, Inc.: Timolol Maleate Ophthalmic Solution Recalled for Labeling Mix-up

Agency Publication Date: June 24, 2020
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Summary

Rising Pharmaceuticals, Inc. has recalled 15,072 bottles of Timolol Maleate sterile ophthalmic solution, a prescription eye medication used to treat glaucoma. The recall was issued because a case of the 0.25% strength medication was incorrectly packaged in outer cartons labeled as the 0.5% strength. While the bottle inside is the correct 0.25% strength, the discrepancy between the outer box and the inner bottle could lead to confusion regarding the dosage. These products were distributed nationwide across the United States.

Risk

A consumer might believe they are using a higher concentration of medication (0.5%) based on the outer box when they are actually using a lower concentration (0.25%). This labeling mix-up could result in patients receiving half of their intended dose if they rely on the outer carton for instructions, potentially leading to poorly controlled eye pressure.

What You Should Do

  1. Check your medication packaging to see if you have Timolol Maleate Sterile Ophthalmic Solution (5 mL) with Lot # 089A016 and an expiration date of 12/2020 or 12/31/2020.
  2. Compare the dosage strength listed on the outer cardboard carton (NDC 64980-514-05 for 0.5%) with the dosage strength listed on the white plastic bottle inside (NDC 64980-513-05 for 0.25%).
  3. If you find a discrepancy between the outer box and the inner bottle, or if your product matches the affected lot number, contact your healthcare provider or pharmacist immediately for guidance on your treatment.
  4. Return any affected or unused medication to the pharmacy where it was purchased for a full refund.
  5. Contact the manufacturer, Rising Pharmaceuticals, Inc., for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmaceutical product refund and consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Timolol Maleate USP, 0.5%, 5 mL, Sterile Ophthalmic Solution
Model:
NDC 64980-514-05
Lot Numbers:
089A016 (Exp 12/31/2020)
Date Ranges: Exp 12/31/2020
Product: Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5 mL
Model:
NDC 64980-513-05
Lot Numbers:
089A016 (Exp 12/2020)
Date Ranges: Exp 12/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85829
Status: Resolved
Manufacturer: Rising Pharmaceuticals, Inc.
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 15,072 bottles
Distributed To: Nationwide
Agency Last Updated: June 29, 2020

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.