CLASS II Drug recall · Reported 19 Feb 2020 · FDA Enforcement Report
Hydrocortisone and Acetic Acid Otic Solution, USP dropper recalled
Akorn is recalling Hydrocortisone and Acetic Acid Otic Solution, USP dropper, distributed nationwide in the US. The recall was initiated on 16 Dec 2019 and the FDA has classified it as Class II.
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-0839-2020
- FDA event ID
- 84913
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Dec 2019
- FDA classified
- 11 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 16 Dec 2019 | Recall initiated by company | |
| 11 Feb 2020 | Classified by FDA | +57 days |
| 19 Feb 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
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
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
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Which lots are affected?
Lot #: 364667, Exp 12/20/2019
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
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|---|---|---|---|---|---|
| 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 Hydrocortisone recalls
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream recalledRapidol | Kenil Healthcare Private | Manufacturing (CGMP) Deviations | DE, NC |
| Drug | CLASS III | Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP dropper recalledHydrocortisone And Acetic Acid | Taro Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone and Acetic Acid Otic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone Ointment recalled by Mckesson Medical-SurgicalHydrocortisone | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hydrocortisone Acet 30mg recalled by Cardinal HealthHydrocortisone Acetate | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |