CLASS III ONGOING Drug recall · Reported 15 Feb 2023 · FDA Enforcement Report
Atropine Sulfate Ophthalmic Solution recalled by Akorn
Akorn is recalling Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, Sterile, distributed nationwide in the US. The recall was initiated on 30 Jan 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0265-2023
- FDA event ID
- 91580
- Recalling firm
- Akorn, Gurnee, IL
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 30 Jan 2023
- FDA classified
- 8 Feb 2023
- Reported
- 15 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 30 Jan 2023 | Recall initiated by company | |
| 8 Feb 2023 | Classified by FDA | +9 days |
| 15 Feb 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Which lots are affected?
Lot: 081031A, Exp 2/28/2023
Where was it sold?
Nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Akorn
All 192| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP 2mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
Other Atropine recalls
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Atropine Sulfate injection, USP, 1 mg/mL recalled by American RegentAtropine Sulfate | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS III | Atropine Sulfate Ophthalmic Solution recalled by Somerset TherapeuticsAtropine Sulfate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS I | Atropine Sulfate Injection, USP 1 mg/ (0.1 mg/mL) recalled by PfizerAtropine Sulfate | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | Atropine Sulfate Injection, USP 8 mg recalled by Accord HealthcareAtropine Sulfate | Accord Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Atropine Sulfate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |