Akorn Recalls Phenylephrine Ophthalmic Solution Due to Sterility Concerns
Akorn, Inc. is recalling 60,176 bottles of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, due to out-of-specification container closure test results that cannot guarantee 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, which corresponds to a 'Severe' severity score under the rubric for significant injury/property-damage reports or high-risk scenarios.
Plain-English summary
Akorn, Inc. is recalling 60,176 bottles of Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle (NDC 17478-201-15). The recall is being conducted because out-of-specification results for the container closure test mean the sterility of the product cannot be guaranteed.
The affected product is identified by Lot # 031908A with an expiration date of 03/20. The product was distributed nationwide in the USA and Puerto Rico.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 60,176
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)
- Lot #: 031908A
- Exp 03/20
Distribution
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 failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- 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
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- LowAkorn Recalls Atropine Sulfate Ophthalmic Solution Due to Viscosity Failure
FDA (Drugs) · 2018-03-14
- ModerateAkorn Atropine Sulfate Eye Solution Recalled for Failed Stability Testing
FDA (Drugs) · 2023-02-15
- SevereAkorn Recalls Sulfacetamide Sodium Ophthalmic Solution Due to Sterility Concerns
FDA (Drugs) · 2016-06-08
- SevereAkorn Recalls Latanoprost Ophthalmic Solution Due to Sterility Assurance Issues
FDA (Drugs) · 2017-04-19
- LowAkorn Recalls Azelastine HCl Ophthalmic Solution Due to Impurities
FDA (Drugs) · 2018-09-05
- SevereBetaxolol Ophthalmic Solution Recalled for Sterility Failure
FDA (Drugs) · 2021-10-13