CLASS III Drug recall · Reported 22 Jul 2020 · FDA Enforcement Report
Proparacaine Hydrochloride Ophthalmic Solution recalled by Akorn
Akorn is recalling Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5% per dropper, Sterile, distributed nationwide in the US. The recall was initiated on 26 Dec 2019 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-1388-2020
- FDA event ID
- 86019
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Dec 2019
- FDA classified
- 14 Jul 2020
- Reported
- 22 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 26 Dec 2019 | Recall initiated by company | |
| 14 Jul 2020 | Classified by FDA | +201 days |
| 22 Jul 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
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
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Why was it recalled?
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Which lots are affected?
Lot 9E52A, exp 04/2021
Where was it sold?
Nationwide 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 Proparacaine recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile) recalledProparacaine Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Temperature Abuse | MD, VA |
| Drug | CLASS II | Proparacaine HCl Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% per dropper recalled | Akorn | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Proparacaine Hydrochloride Ophthalmic Solution recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |