Leiter's Compounding Ophthalmic Solution Recall: Sterility Risk
Leiter's Compounding recalls cyclopentolate, tropicamide, and phenylephrine eye drops due to lack of sterility assurance in compounded products. All unexpired lots from specific NDC numbers are affected.
Lower-risk recall
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Contact the company
What happened, in plain English
Leiter's Compounding has recalled certain eye drop solutions because they were compounded without proper sterility assurance. This could lead to infections if used improperly. Affected products include specific volumes and expiration dates. Read more at govinfonow.com/recall/42421-leiter-s-compounding-ophthalmic-solution-recall-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42421-leiter-s-compounding-ophthalmic-solution-recall-sterility-risk · Updated October 9, 2026 · FDA enforcement record: FDA #D-0013-2017
Cite this page
“Leiter's Compounding Ophthalmic Solution Recall: Sterility Risk.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42421-leiter-s-compounding-ophthalmic-solution-recall-sterility-risk. Based on FDA recall #D-0013-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0013-2017%22&limit=1).
Why it’s dangerous
The eye drops were compounded using filters that did not ensure sterility, which could lead to infections if the product is used. This is a risk during medical procedures where sterile solutions are required.
Who’s affected
People who have the recalled eye drops (1 mL or 10 mL in 15 mL dropper bottles) with unexpired lots from the listed dates. Those using these drops for eye treatments are most at risk.
How to tell if you have this one
Check for the 1 mL or 10 mL total volume in a 15 mL dropper bottle with NDC numbers 70360-017-38 or 70360-017-39. The products were made between specific expiration dates listed in the recall.
- Brand
Leiter's Compounding- Category
Drug
All 9 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots |
|---|---|
| D-0010-2017 | Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39; All unexpired lots; Expirations dates of 11/13/2016 to 01/02/2017 |
| D-0011-2017 | Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35; All unexpired lots; Expirations dates of .09/20/2016 to 10/10/2016 |
| D-0012-2017 | Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35; All unexpired lots; Expirations dates of 09/24/2016 to 02/06/2017 |
| D-0013-2017 | Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38; All unexpired lots; a) Expirations dates of 10/03/2016 to 11/06/2016 and b) 09/25/2016 to 10/01/2016 |
| D-0014-2017 | Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35; All unexpired lots; Expirations dates of 10/03/2016 to 12/19/2016 |
| D-0015-2017 | Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35; All unexpired lots; Expirations dates of .11/05/2016 to 12/10/2016. |
| D-0016-2017 | Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35; All unexpired lots; Expirations dates of 09/21/2016 to 2/2/2017 |
| D-0017-2017 | Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA; All unexpired lots; Expirations dates of 10/11/2016 to 01/16/2017 |
| D-0018-2017 | Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35; All unexpired lots; Expirations dates of 10/05/2016 to 01/10/2017 |
What to do — step by step
Check Product Details
Identify the NDC numbers 70360-017-38 or 70360-017-39 and expiration dates listed in the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0013-2017 (September 20, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0013-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.