CLASS II Drug recall · Reported 22 Sep 2021 · FDA Enforcement Report
Spironolactone Ophthalmic Solution 0.005 mg/mL recalled
Prescription Labs is recalling Spironolactone Ophthalmic Solution 0.005 mg/mL, distributed nationwide in the US. The recall was initiated on 18 Aug 2021 and the FDA has classified it as Class II.
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-0804-2021
- FDA event ID
- 88515
- Recalling firm
- Prescription Labs, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Aug 2021
- FDA classified
- 16 Sep 2021
- Reported
- 22 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Blood Pressure Medication
Timeline
| 18 Aug 2021 | Recall initiated by company | |
| 16 Sep 2021 | Classified by FDA | +29 days |
| 22 Sep 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
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
Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lots: 03012021@35; 04132021@10; 05102021@12; 06012021@28; 07012021@25; 03012021@36; 04132021@12; 05102021@11; 06012021@29; 07132021@14; 03152021@9; 06162021@21; 07132021@16; 03152021@10; 06162021@22
Where was it sold?
Nationwide within the United States
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Spironolactone recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Spironolactone Tablets, USP, 25 mg recalledSpironolactone | SUN Pharmaceutical Industries | Other | Nationwide |
| Drug | CLASS I | Spironolactone Tablets, USP, 25 mg recalled by Bryant Ranch Prepack | Bryant Ranch Prepack | Packaging Defects | Nationwide |
| Drug | CLASS II | Spironolactone Tablets, USP, 50 mg recalled by Bryant Ranch Prepack | Bryant Ranch Prepack | Packaging Defects | Nationwide |
| Drug | CLASS II | Spironolactone 5 mg/mL Susp, Health Innov Pharmacy recalled | Health Innovations Pharmacy | Sterility | NC |
| Drug | CLASS II | Spironolactone tablets, USP 50 mg recalled by Greenstone | Greenstone | Potency & Assay | Nationwide |