Leiter's Compounds Recalls Prednisolone Placebo Due to Sterility Concerns
Leiter's Compounding is recalling placebo ophthalmic suspensions because they were produced using recalled filters, raising concerns about sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant health consequences (such as sterility failures in ophthalmic products) align with a 'Severe' rating, particularly given the lack of assurance of sterility which poses a direct risk of infection.
Plain-English summary
Leiter's Compounding is recalling Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle. The recall affects 76,315 total units distributed nationwide. The products are identified by expiration dates ranging from 10/11/2016 to 01/16/2017.
The recall was initiated due to a lack of assurance of sterility. The source text indicates that all compounded products within the expiration period were produced using recalled filters. This defect raises the potential for contamination, although the source does not specify the nature of the contamination or report any specific illnesses.
Consumers should stop using the affected products and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
- Manufacturer
- Leiter's Compounding
- Category
- Drug — Ophthalmic
- Affected units
- 76,315
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 (2)
- All unexpired lots
- Expirations dates of 10/11/2016 to 01/16/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Leiter's Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Leiter's Compounding
See all →- SevereLeiter's Compounding Recalls Cefuroxime Sodium Injection Due to Sterility Concerns
FDA (Drugs) · 2016-10-19
- SevereLeiter's Compounding Recalls Moxifloxacin Intravitreal Injection Due to Sterility Concerns
FDA (Drugs) · 2016-10-19
- SevereFDA Recalls Lidocaine and Phenylephrine Injection Due to Sterility Concerns
FDA (Drugs) · 2016-10-19
- SevereLeiter's Compounding Recalls Vancomycin Injection Due to Sterility Concerns
FDA (Drugs) · 2016-10-19
- SevereLeiter's Compounding Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2016-10-19
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22