Rising Pharmaceuticals, Inc. recalls Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed
Rising Pharmaceuticals recalls Timolol Maleate 0.5% eye drops due to label mix-up with 0.25% solution. This could lead to incorrect dosing if used without proper labeling.
Lower-risk recall
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Contact the company & request your remedy
What happened, in plain English
Rising Pharmaceuticals is recalling Timolol Maleate 0.5% eye drops because the labeling is mixed up with the 0.25% strength. This could cause incorrect dosing if someone uses the wrong strength without realizing it. Read more at govinfonow.com/recall/37690-rising-pharmaceuticals-timolol-0-5-ophthalmic-solution-recall-label-mix.
Source Summary by GovInfoNow · govinfonow.com/recall/37690-rising-pharmaceuticals-timolol-0-5-ophthalmic-solution-recall-label-mix · Updated October 5, 2026 · FDA enforcement record: FDA #D-1367-2020
Cite this page
“Rising Pharmaceuticals Timolol 0.5% Ophthalmic Solution Recall: Label Mix-Up Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37690-rising-pharmaceuticals-timolol-0-5-ophthalmic-solution-recall-label-mix. Based on FDA recall #D-1367-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1367-2020%22&limit=1).
Why it’s dangerous
The outer carton for the 0.5% solution incorrectly contains the 0.25% solution bottle inside. This mix-up could lead to using the wrong concentration of medication, which might cause incorrect dosing if not properly identified.
Who’s affected
Prescription eye drop users who have the specific Timolol Maleate 0.5% solution with the NDC 64980-514-05. People using the product without checking the label may be at risk of incorrect dosing.
How to tell if you have this one
Check for the NDC 64980-514-05 on the product label. The product was distributed by Rising Pharmaceuticals, Inc. with a specific lot number (089A016) and expiration date (12/31/2020).
- Brand
Rising Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
U.S.A. Nationwide- NDC
64980-513-05, 64980-513-01, 64980-513-15, 64980-514-05, 64980-514-01, 64980-514-15
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1367-2020 | Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Industrial Area, Waluj, Aurangbad - 431 136 Marahastra, India, NDC 64980-514-05; Lot # 089A016, Exp 12/31/2020 | N/A |
| D-1368-2020 | Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Waluj, Aurangabad - 431-136 Maharashtra, India, NDC 64980-513-05; Lot # 089A016, Exp 12/2020 | 15,072 bottles |
What to do — step by step
Check Label
Verify the product label for the NDC 64980-514-05 and lot number 089A016 to confirm it's the correct 0.5% solution.
Questions people ask
Why is this product being recalled?
The recall is due to a label mix-up where the outer carton for 0.5% solution contains the 0.25% solution bottle inside, which could lead to incorrect dosing.
What should I do if I have this product?
Check the label for NDC 64980-514-05 and lot number 089A016. If you have the correct product, no action is needed.
Is there a risk of serious injury from this mix-up?
The recall indicates a labeling error that could lead to incorrect dosing, but the official notice does not specify a risk of serious injury.
Contact Rising Pharmaceuticals
We’ve drafted a message you can send Rising Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1367-2020 — Rising Pharmaceuticals Rising Pharmaceuticals Hello, I own a Rising Pharmaceuticals that is covered by recall D-1367-2020 from Rising Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1367-2020 (November 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1367-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.