CLASS III Drug recall · Reported 5 Sep 2018 · FDA Enforcement Report
Azelastine HCl Ophthalmic Solution 0.05% in HDPE bottle recalled
Akorn is recalling Azelastine HCl Ophthalmic Solution 0.05% in HDPE bottle per, distributed nationwide in the US. The recall was initiated on 8 Aug 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-1168-2018
- FDA event ID
- 80767
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 Aug 2018
- FDA classified
- 29 Aug 2018
- Reported
- 5 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 8 Aug 2018 | Recall initiated by company | |
| 29 Aug 2018 | Classified by FDA | +21 days |
| 5 Sep 2018 | 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 Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
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
Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
Which lots are affected?
Lot# 6K89A, 6K90A, 6K92A, exp 9/18
Where was it sold?
Nationwide 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 Azelastine recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelastine HCl Ophthalmic Solution recalled by ApotexAzelastine Hydrochloride | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Dymista (azelastine hydrochloride recalled by Mylan PharmaceuticalsDymista | Mylan Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Dymista (azelastine hydrochloride recalled by Mylan PharmaceuticalsDymista | Mylan Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS III | Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray) recalledAzelastine Hydrochloride | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |