FDAFDA recall D-0856-2026 · Sep 30, 2026
Sterling Pharmaceutical Services LLC: Reliable -1 Laboratories recall
Recall found
Product
Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55.
Reason for recall
Lack of Assurance of Sterility
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #3192, Exp Date 01/312027; 3293, 3336 Exp Date 06/30/2027
- Quantity
- 11083 bottles
- Distribution
- USA Nationwide
- Recalling firm
- Sterling Pharmaceutical Services LLC, Dupo, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-20
Source: openFDA enforcement record D-0856-2026 · search recall number D-0856-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.