CLASS III Drug recall · Reported 22 Nov 2017 · FDA Enforcement Report
Lumigan (bimatoprost ophthalmic solution) recalled by Allergan Sales
Allergan Sales is recalling Lumigan (bimatoprost ophthalmic solution) 0.01%, distributed nationwide in the US. The recall was initiated on 19 Oct 2017 and the FDA has classified it as Class III.
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-0078-2018
- FDA event ID
- 78325
- Recalling firm
- Allergan Sales, Waco, TX
- Brand
- Lumigan
- Manufacturer
- Allergan, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Oct 2017
- FDA classified
- 13 Nov 2017
- Reported
- 22 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 19 Oct 2017 | Recall initiated by company | |
| 13 Nov 2017 | Classified by FDA | +25 days |
| 22 Nov 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
Where it was distributed
Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications.
Which lots are affected?
Lot #: 92575 Exp. JUN-2018
Where was it sold?
Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
Other products in this recall event
1 other product · FDA event 78325This product is part of a recall event; the main page for the event is Combigan (brimonidine tartrate/timolol maleate ophthalmic recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Combigan (brimonidine tartrate/timolol maleate ophthalmic recalledCombigan | Allergan Sales | Potency & Assay | Nationwide |
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 II | Combigan (brimonidine tartrate/timolol maleate ophthalmic recalledCombigan | Allergan Sales | Manufacturing (CGMP) Deviations | TN |
| 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 Bimatoprost recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bimatoprost powder, Bulk Ingredient, a) recalled by Medisca | Medisca | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Bimatoprost Ophthalmic Solution, 0.03%, For Use recalled | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Bimatoprost Ophthalmic Solution recalled by SandozBimatoprost | Sandoz | Packaging Defects | Nationwide |
| Drug | CLASS III | Bimatoprost Ophthalmic Solution recalled by Lupin Pharmaceuticals | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Lumigan (bimatoprost ophthalmic solution) recalled by Allergan SalesLumigan | Allergan Sales | Potency & Assay | Nationwide |