CLASS III Drug recall · Reported 8 Jan 2020 · FDA Enforcement Report
Bimatoprost Ophthalmic Solution, 0.03%, For Use recalled
Lupin Pharmaceuticals is recalling Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, distributed nationwide in the US. The recall was initiated on 13 Dec 2019 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-0635-2020
- FDA event ID
- 84495
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Dec 2019
- FDA classified
- 2 Jan 2020
- Reported
- 8 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 13 Dec 2019 | Recall initiated by company | |
| 2 Jan 2020 | Classified by FDA | +20 days |
| 8 Jan 2020 | Published in enforcement report | +6 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: Out-of-specification result observed in any other individual impurity.
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
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Which lots are affected?
Lot# H801686, Exp. 12/31/2019.
Where was it sold?
Nationwide in the U.S.
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.
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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 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 |
| Drug | CLASS III | Lumigan (bimatoprost ophthalmic solution) recalled by Allergan SalesLumigan | Allergan Sales | Potency & Assay | Nationwide |