CLASS III Drug recall · Reported 1 Jul 2020 · FDA Enforcement Report
Timolol Maleate USP, 0.5%, Sterile Opthalmic Solution recalled
Rising Pharmaceuticals is recalling Timolol Maleate USP, 0.5%, Sterile Opthalmic Solution, distributed nationwide in the US. The recall was initiated on 15 Nov 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1367-2020
- FDA event ID
- 85829
- Recalling firm
- Rising Pharmaceuticals, Saddle Brook, NJ
- Brand
- Timolol Maleate
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 15 Nov 2019
- FDA classified
- 29 Jun 2020
- Reported
- 1 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 15 Nov 2019 | Recall initiated by company | |
| 29 Jun 2020 | Classified by FDA | +227 days |
| 1 Jul 2020 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot # 089A016, Exp 12/31/2020
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85829| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Timolol Maleate Sterile Opthalmic Solution recalledTimolol Maleate | Rising Pharmaceuticals | Sterility | Nationwide |
More recalls from Rising Pharmaceuticals
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Warfarin Sodium Tablets, USP 1 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg recalledMethylphenidate Hydrochloride | Rising Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine HCl Tablets, 25 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Packaging Defects | NJ |
| Drug | CLASS III | Timolol Maleate Sterile Opthalmic Solution recalledTimolol Maleate | Rising Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Valsartan Tablets 160 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Nitrosamine Impurity | Nationwide |
Other Timolol recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |