CLASS III Drug recall · Reported 19 Jan 2022 · FDA Enforcement Report
Oxycodone Hydrochloride Oral Solution, USP 5 mg per (1 mg/mL) recalled
Akorn is recalling Oxycodone Hydrochloride Oral Solution, USP 5 mg per (1 mg/mL), distributed nationwide in the US. The recall was initiated on 3 Dec 2021 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-0368-2022
- FDA event ID
- 89142
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Dec 2021
- FDA classified
- 13 Jan 2022
- Reported
- 19 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Pain Medication
Timeline
| 3 Dec 2021 | Recall initiated by company | |
| 13 Jan 2022 | Classified by FDA | +41 days |
| 19 Jan 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Missing Label
Product as listed by the FDA
Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Labeling: Missing Label
Which lots are affected?
Lots: 377186 Exp. 2/28/2023; 377188 Exp. 3/31/2023
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.
Other products in this recall event
1 other product · FDA event 89142This product is part of a recall event; the main page for the event is Morphine Sulfate Oral Solution 100 mg per (20 mg/mL) recalled by Akorn.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Morphine Sulfate Oral Solution 100 mg per (20 mg/mL) recalled by Akorn | Akorn | Labeling Errors | Nationwide |
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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 Oxycodone recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |
| Drug | CLASS III | Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg recalledOxaydo | Zyla Life Sciences US | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |