Allergan Blephamide Ophthalmic Ointment Recall: Impurities Risk
Allergan recalls Blephamide ophthalmic ointment due to impurities in stability testing. This medication may not be safe for use as impurities could affect its effectiveness or safety.
Lower-risk recall
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Contact the company
What happened, in plain English
Allergan is recalling a specific ophthalmic ointment product due to stability testing showing impurities that could affect its safety. This recall applies to prescription-only items sold with a specific lot number and expiration date. Read more at govinfonow.com/recall/41635-allergan-blephamide-ophthalmic-ointment-recall-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41635-allergan-blephamide-ophthalmic-ointment-recall-impurities-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0929-2017
Cite this page
“Allergan Blephamide Ophthalmic Ointment Recall: Impurities Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41635-allergan-blephamide-ophthalmic-ointment-recall-impurities-risk. Based on FDA recall #D-0929-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0929-2017%22&limit=1).
Why it’s dangerous
The ointment failed stability testing for impurities, meaning it may contain substances that could affect safety or effectiveness. This is a quality issue that could lead to reduced medication performance or potential adverse reactions.
Who’s affected
Prescription users of Bleph: 10%/0.2% sterile ophthalmic ointment, 3.5g tube (lot 93802, expires Nov 2019). Patients with eye conditions requiring this medication are most at risk.
How to tell if you have this one
Check for the product name 'Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube' on the label. The lot number is 93802 and it expires November 2019.
- Brand
Allergan- Category
Drug
What to do — step by step
Check Product Label
Look for the product name and lot number 93802 on the ointment tube.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
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-0929-2017 (May 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0929-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.