Sun Pharma Recalls CEQUA Eye Drops for Subpotency and Particulates
Sun Pharmaceutical Industries is recalling CEQUA (cyclosporine) ophthalmic solution due to subpotent drug levels and the presence of particulates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. A score of 2 is assigned to reflect the presence of particulates and subpotency, which are quality defects that may impact efficacy or safety, but without reported injuries or a higher agency classification.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling CEQUA (cyclosporine ophthalmic solution) 0.09% single-use vials. The recall was initiated because the product was found to be subpotent and contained particulates. The affected product is a prescription ophthalmic solution manufactured for Sun Pharma Global FZE by Laboratoire Unither in France and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, NJ.
The recall covers specific lots of the 60 Single-Use Vial packages (NDC 47335-506-96). The identified lots are #10009 with an expiration date of 03/2022 and #10006 with an expiration date of 01/2022. The product was distributed nationwide in the US.
Consumers and healthcare providers should stop using the affected lots of CEQUA and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- CEQUA (CYCLOSPORINE)
- Brand
- CEQUA
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Ophthalmic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # 10009
- exp. date 03/2022 10006
- exp. date 01/2022
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CEQUA
- ModerateCequa cyclosporine ophthalmic solution recalled nationwide for subpotency
FDA (Drugs) · 2023-09-27
- ModerateOphthalmic drug recalled for subpotency and particulate matter
FDA (Drugs) · 2022-04-13
- LowSun Pharma Recalls Subpotent Cequa Cyclosporine Ophthalmic Solution Vials
FDA (Drugs) · 2021-03-10
Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC
See all →- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
- HighPerampanel Prescription Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-07-01
- HighBudesonide inhalation ampules contain black and brown specks and particles
FDA (Drugs) · 2026-06-17
- SevereDoxorubicin liposome injection vials contain glass particulate matter
FDA (Drugs) · 2026-06-17
Same hazard · subpotency
See all →- ModerateGood Neighbor Pharmacy Earwax Removal Drug Recalled for Low Potency
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateMeijer Earwax Removal Kit Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22