Tacrolimus eye drops recalled due to sterility concerns
Olympia Pharmacy is recalling compounded tacrolimus eye drops because FDA inspection findings raised concerns about quality control and sterility assurance.
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, which corresponds to a 'Severe' severity score under the rubric, particularly given the risk of sterility failure in an ophthalmic product.
Plain-English summary
Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling two lots of compounded tacrolimus (0.02% and 0.03%) eye drops. The recall was initiated after FDA inspection findings resulted in concerns regarding the quality control processes used to ensure the sterility of the product.
The affected products are identified by lot codes C51012 (expiration date 9/12/13) and C51201 (expiration date 9/6/13). These drops were distributed nationwide and in Puerto Rico.
Consumers who have these specific lots of tacrolimus eye drops should stop using them and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- Tacrolimus (0.02% and 0.03%) drops, compounded by Olympia Pharmacy, Orlando, FL
- Manufacturer
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Category
- Drug — Compounded Ophthalmic
- Hazard
- Affected units
- 2
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 (1)
- C51012 Exp 9/12/13 and C51201 Exp 9/6/13
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 105 recalled by Lowlite Investments, Inc. D/B/A Olympia Pharmacy 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 105 products in this recall →Related recalls
Same manufacturer · Lowlite Investments, Inc. D/B/A Olympia Pharmacy
See all →- SevereOlympia Pharmacy Recalls Diclazuril Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- HighOlympia Pharmacy Recalls Metabolase Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- SevereOlympia Pharmacy Recalls Oxytocin Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- SevereOlympia Pharmacy Recalls Betamethasone Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
- SevereOlympia Pharmacy Recalls HACC 270.1 Injection Due to Sterility Concerns
FDA (Drugs) · 2013-07-17
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29