Akorn Recalls Latanoprost Ophthalmic Solution Due to Sterility Assurance Issues
Akorn, Inc. is recalling Latanoprost Ophthalmic Solution, 0.005%, because bottles were found empty, under-filled, or leaking, compromising sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. The hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of serious injury or adverse health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Akorn, Inc. is recalling 107,940 bottles of Latanoprost Ophthalmic Solution, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottles. The product is prescription-only and was distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The product was found to be empty, under-filled, or leaking. Specific lots affected include LAB15G52, LAB11G52, LAB18I52, LAB9L52, LAB1A62, and LAB9A62, with expiration dates ranging from 6/17 to 12/17.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- Product
- LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 107,940
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 (10)
- Lot # LAB15G52
- LAB11G52
- Exp 6/17
- LAB18I52
- Exp 8/17
- LAB9L52
- 11/17
- LAB1A62
- LAB9A62
- Exp 12/17
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Akorn, Inc.
See all →- HighTobramycin Ophthalmic Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighGuaifenesin Oral Solution Recalled Due to Incomplete Stability Studies
FDA (Drugs) · 2023-06-07
- HighFDA Recalls Calcitriol Injection Due to Manufacturing Practice Violations
FDA (Drugs) · 2023-06-07
- HighAkorn Hydromorphone Hydrochloride Injection Recalled Due to CGMP Deviations
FDA (Drugs) · 2023-06-07
- HighMidazolam Injection Recalled Due to Manufacturing Compliance and Stability Study Issues
FDA (Drugs) · 2023-06-07
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- LowAkorn Recalls Atropine Sulfate Ophthalmic Solution Due to Viscosity Failure
FDA (Drugs) · 2018-03-14
- SevereAkorn Recalls Phenylephrine Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2019-10-09
- SevereApotex Recalls Latanoprost Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2013-08-14
- HighBetaxolol ophthalmic solution recalled for manufacturing process violations
FDA (Drugs) · 2023-01-25
- SevereBetaxolol Ophthalmic Solution Recalled for Sterility Failure
FDA (Drugs) · 2021-10-13
- SevereAkorn Recalls Sulfacetamide Sodium Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2016-06-08