CLASS III Drug recall · Reported 13 Feb 2019 · FDA Enforcement Report
Bimatoprost Ophthalmic Solution recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Bimatoprost Ophthalmic Solution 0.03%, distributed nationwide in the US. The recall was initiated on 28 Jan 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-0429-2019
- FDA event ID
- 82022
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Jan 2019
- FDA classified
- 5 Feb 2019
- Reported
- 13 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 28 Jan 2019 | Recall initiated by company | |
| 5 Feb 2019 | Classified by FDA | +8 days |
| 13 Feb 2019 | Published in enforcement report | +8 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: OOS results observed in any other individual impurity and total impurities.
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%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
Where it was distributed
Nationwide within the United States.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Which lots are affected?
a) H804506 Exp. 06/2020; 803555 Exp. 04/2020; H805394, Exp. 08/2020 b) H804112 Exp. 05/2020; H803220 Exp. 03/2020
Where was it sold?
Nationwide within the United States.
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.
More recalls from Lupin Pharmaceuticals
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalledGlucagon | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | 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 | 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 |