Drug recall: Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc.…
Class II FDA enforcement event 96836. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Failed Impurities/Degradation Specifications
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Alembic Pharmaceuticals Limited started this drug recall on 7 May 2025. The firm address in the FDA record is in Panchmahal. FDA put the recall in Class II. FDA event 96836 has 1 product record. The first FDA enforcement report date is 4 Jun 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide
Recalling firm
Alembic Pharmaceuticals Limited, Panchmahal, N/A, India.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0447-2025 | Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17 | N/A | Class II | Ongoing | 4 Jun 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2025
- 322
- Share of these events in Class II
- 79%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Dec 2025 | Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Lim | Drug | Class III | 1 |
| 10 Oct 2025 | Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceutical | Drug | Class III | 1 |
| 25 Jul 2025 | Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Pan | Drug | Class II | 1 |
| 9 May 2025 | Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Div | Drug | Class II | 1 |
| 17 Mar 2021 | Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation | Drug | Class I | 1 |
| 10 Jun 2020 | Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formu | Drug | Class II | 1 |
Official channels
- FDA enforcement report D-0447-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 96836. https://recallregister.com/fda/ii/96836/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide
- What quantity of product is in FDA event 96836?
- The FDA record gives this quantity:
N/A
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2025 have the same class?
- 79% of the 322 drug events that started in 2025 are in Class II.