Lupin prednisolone acetate ophthalmic suspension recall: Foreign substance present
Lupin Pharmaceuticals recalls prednisolone acetate ophthalmic suspension (1%) due to foreign substance presence. Rx-only medication with specific NDC codes and expiration dates affected.
Lower-risk recall
Presence of Foreign Substance
Contact the company
What happened, in plain English
Lupin Pharmaceuticals is recalling prednisolone acetate ophthalmic suspension (1%) products that may contain foreign substances. This could cause eye irritation or infection if used. Read more at govinfonow.com/recall/31223-lupin-prednisolone-acetate-ophthalmic-suspension-recall-foreign-substance-present.
Source Summary by GovInfoNow · govinfonow.com/recall/31223-lupin-prednisolone-acetate-ophthalmic-suspension-recall-foreign-substance-present · Updated August 10, 2026 · FDA enforcement record: FDA #D-0655-2026
Cite this page
“Lupin prednisolone acetate ophthalmic suspension recall: Foreign substance present.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31223-lupin-prednisolone-acetate-ophthalmic-suspension-recall-foreign-substance-present. Based on FDA recall #D-0655-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0655-2026%22&limit=1).
Why it’s dangerous
The medication contains a foreign substance that could cause eye irritation or infection when used. This is a contamination issue during manufacturing.
Who’s affected
People with prescriptions for this eye drop medication. Those using the recalled products are at risk of eye irritation or infection.
How to tell if you have this one
Check for the product name 'prednisolone acetate ophthalmic suspension, 1%' with NDC codes 70748-332-02, 70748-332-03, or 70748-332-04. The expiration dates listed in the recall range from July 2026 to February 2028.
- Brand
Lupin Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC codes 70748-332-02, 70748-332-03, or 70748-332-04 on the product label.
Contact Your Doctor
If you have the recalled product, contact your doctor for advice on safe use or alternatives.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0655-2026 (June 4, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0655-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.