FDA recall, , Moderate risk
Alembic Pharmaceuticals Bromfenac Ophthalmic Solution 0.07%
Bromfenac Ophthalmic Solution 0.07% failed impurities and degradation specifications at the 20th month stability testing.
Summary by Recall Canary from the FDA notice
What happened
Alembic Pharmaceuticals, Inc. recalled Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, because it failed impurities and degradation specifications at the 20th month stability testing. The product was distributed nationwide in the USA. The recall began on March 18, 2026, and was added to the FDA's Enforcement Report on March 31, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Bromfenac Ophthalmic Solution 0.07%
- NDC
- 62332-583-03
- Lot code
- 7240184
- 7240185
- 7240186
- 7240187
- 7240278
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- ALEMBIC PHARMACEUTICALS, INC.
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98647
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
