CLASS III Drug recall · Reported 14 Mar 2018 · FDA Enforcement Report
Atropine Sulfate Ophthalmic 1% Solution, USP per, Sterile recalled
Akorn is recalling Atropine Sulfate Ophthalmic 1% Solution, USP per, Sterile, distributed nationwide in the US. The recall was initiated on 21 Feb 2018 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-0577-2018
- FDA event ID
- 79278
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Feb 2018
- FDA classified
- 5 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 21 Feb 2018 | Recall initiated by company | |
| 5 Mar 2018 | Classified by FDA | +12 days |
| 14 Mar 2018 | Published in enforcement report | +9 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 Specification: OOS low viscosity results discovered during retain testing.
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 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Which lots are affected?
Lot: 011037A
Where was it sold?
Nationwide in the USA
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 |