CLASS II Drug recall · Reported 3 Apr 2019 · FDA Enforcement Report
Combigan (brimonidine tartrate/timolol maleate ophthalmic recalled
Allergan Sales is recalling Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, distributed in Tennessee. The recall was initiated on 19 Mar 2019 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-1056-2019
- FDA event ID
- 82424
- Recalling firm
- Allergan Sales, Waco, TX
- Brand
- Combigan
- Manufacturer
- Allergan, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Mar 2019
- FDA classified
- 22 Mar 2019
- Reported
- 3 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Eye Drops
Timeline
| 19 Mar 2019 | Recall initiated by company | |
| 22 Mar 2019 | Classified by FDA | +3 days |
| 3 Apr 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations
Product as listed by the FDA
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05
Where it was distributed
TN only
Questions about this recall
Why was it recalled?
cGMP Deviations
Which lots are affected?
Lot#: 99946 Exp. January 16, 2021
Where was it sold?
TN only
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.
More recalls from Allergan Sales
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Keller Funnel recalled by Allergan Sales | Allergan Sales | Other | Nationwide |
| Drug | CLASS III | Lumigan (bimatoprost ophthalmic solution) recalled by Allergan SalesLumigan | Allergan Sales | Potency & Assay | Nationwide |
| Drug | CLASS III | Combigan (brimonidine tartrate/timolol maleate ophthalmic recalledCombigan | Allergan Sales | Potency & Assay | Nationwide |
| Drug | CLASS II | Blephamide (sulfacetamide sodium recalled by Allergan Sales | Allergan Sales | Potency & Assay | Nationwide |
| Drug | CLASS III | Lumigan (bimatoprost ophthalmic solution) recalled by Allergan SalesLumigan | Allergan Sales | Potency & Assay | Nationwide |
Other Brimonidine recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5% recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate Ophthalmic Solution recalled by Apotex | Apotex | Sterility | Nationwide |
| Drug | CLASS III | Brimonidine Tartrate Opthalmic Solution recalledBrimonidine Tartrate | Somerset Therapeutics | Potency & Assay | Nationwide |