Akorn recalls 30mL Morphine Sulfate Oral Solution bottles (Rx only) due to missing labels. This could lead to incorrect dosing if used without proper labeling.
“Akorn Morphine Sulfate Oral Solution: Missing Label Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35489-akorn-morphine-sulfate-oral-solution-missing-label-hazard. Based on FDA recall #D-0367-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0367-2022%22&limit=1).
The FDA announced on Dec. 3, 2021, that Akorn Inc. voluntarily recalled 10,836 bottles of Morphine Sulfate Oral Solution due to missing labels. The recall affects specific lots distributed nationwide.
How to tell if you have it
Brand: Akorn
Product: Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles
NDC: 50383-965-30
Lot code: 375153
Expiration date: 10/31/2022
The hazard
The hazard is missing labeling on the bottles. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Akorn, Inc. has had 64 other recalls since Aug. 5, 2014. Recent Akorn recalls include a midazolam injection recall on April 26, 2023, for stability issues after the manufacturer closed, and an atropine sulfate ophthalmic solution recall on Jan. 30, 2023, for failed stability specifications. Other recent recalls of similar products include American Regent Levocarnitine Injection (April 16, 2026), Winder Morphine Sulfate Oral Solution (Nov. 26, 2025), and Fresen Morphine Syringes (Aug. 4, 2026).
How to tell if you have this one
Check for 30mL bottles labeled 'Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL)' with NDC 50383-965-30 and lot number 375153. These were sold by Hi-Tech Pharmacal Co., Inc. in Amityville, NY.
Brand
Akorn
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Terminated
Distribution
Nationwide USA
Recall number
Product, codes & lots
Quantity
D-0367-2022
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30; Lot: 375153 Exp. 10/31/2022
10,836 bottles
D-0368-2022
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; Lots: 377186 Exp. 2/28/2023; 377188 Exp. 3/31/2023
8184 bottles
Based on the official FDA remedy
What to do — step by step
Check Label
Look for the missing label on the bottle to confirm if it's part of the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0367-2022 (December 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0367-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.