Ophthalmic drug recalled for subpotency and particulate matter
Sun Pharmaceutical recalls CEQUA cyclosporine ophthalmic solution nationwide due to low assay results and particulate matter found in specific lots.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class III recall with no reported illnesses or injuries. The hazards—subpotency and particulate matter—are quality defects without documented patient harm. FDA Class III recalls typically score 1 or 2; the manufacturing quality issues elevate this to Moderate rather than Low.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling CEQUA (cyclosporine ophthalmic solution) 0.09% due to out-of-specification assay results and the presence of particulate matter in the recalled product.
The affected product is distributed nationwide in the United States. The recall involves 73,030 boxes packaged as 6 pouches × 10 single-use vials (0.25 mL each) per box, with lot numbers 10014 and 10016, with an expiration date of August 2022.
Cyclosporine is used to treat dry eye disease. Subpotent formulation may result in reduced therapeutic efficacy, while particulate matter in an ophthalmic product may cause ocular irritation or other adverse effects. Patients currently using this medication should consult their healthcare provider.
The recalled product
- Product
- CEQUA (CYCLOSPORINE)
- Brand
- CEQUA
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Ophthalmic
- Affected units
- 73,030
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: 10014
- 10016
- Exp 08/2022
Distribution
Distributed nationwide across the United States.
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