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U.S. Department of Health and Human Services

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Questions and Answers for Consumers about FDA’s Action Involving Unapproved Narcotics Containing Morphine Sulfate, Hydromorphone, or Oxycodone

What action is FDA taking regarding drug products containing morphine sulfate, hydromorphone, or oxycodone?

The Food and Drug Administration (FDA) has sent warning letters directing companies to stop making and distributing specific narcotic products in certain dosage forms that lack the required FDA approval.  Affected products include unapproved high concentrate oral solutions containing morphine sulfate and unapproved immediate release tablets containing morphine sulfate, hydromorphone, or oxycodone.  Below is a list of the specific drug products involved in this action. Consumers should be aware that approved versions of these drugs will remain available.

When is this action going to take effect?

Manufacturers have 60 days after the dates of the Warning Letters to cease manufacturing of new product, and distributors have 90 days after the dates of the Warning Letters to cease further shipment of existing products.  Previously manufactured unapproved products affected by this action may still be found on pharmacy shelves for a short period of time.

Are these products recalled from the pharmacy?

This is not a recall.  As stated above, manufacturers have 60 days to cease manufacturing of new product, and distributors have 90 days to cease further shipment of existing products.  Previously manufactured unapproved products affected by this action may still be found on pharmacy shelves for a short period of time.

Why is FDA taking this action?

FDA is taking this action as part of its continuing effort to ensure that drugs marketed in the U.S. have the required FDA approval, and that they are safe, effective, of good quality, and appropriately labeled.  Companies that market these unapproved products have not demonstrated to FDA that their products are safe and effective and that they meet current standards for manufacturing and have accurate and complete labeling.

What effect will FDA’s action have on people who use morphine sulfate oral solutions and immediate release morphine sulfate, hydromorphone, or oxycodone tablets? Are there alternatives?

Consumers will continue to have access to FDA-approved narcotic drugs.  Today’s action will have the most impact on consumers who use high concentrate unapproved morphine sulfate oral solutions and unapproved immediate release tablets containing morphine sulfate, hydromorphone, or oxycodone.  There are, however, several firms that market products containing the same active ingredients that have FDA-approved applications (see table below).  There are also other FDA-approved drugs, including different narcotics, which can be used to relieve pain.  Consumers should consult a healthcare professional for detailed guidance on their treatment options.

How can people tell the difference between FDA-approved and unapproved products?

While the FDA works to ensure that all marketed unapproved drug products obtain approval or are removed from the market, healthcare practitioners and consumers can use Drugs@FDA or the National Drug Code (NDC) Directory to determine whether a drug is FDA-approved.  Drugs@FDA contains most FDA-approved drug products.  The NDC Directory is limited to prescription drugs and insulin products.  Search results from the NDC directory include a column marked "Application Number."  FDA-approved products will have an associated NDA (new drug application) or ANDA (abbreviated new drug application) number in this column.
What are Morphine Sulfate, Oxycodone, and Hydromorphone?

The active pharmaceutical ingredients morphine sulfate , hydromorphone, and oxycodone are potent drugs of the opioid class.  Opioids are a family of related drugs that relieve pain. All of the opioids (sometimes called narcotics) are chemically related to opium, which is a substance collected from the poppy plant.  Prescription opioids have benefit when used properly and are an essential component of pain management and treatment of pains such as cancer pain, but opioid drugs also have serious risks when used improperly.  Tolerance to, and physical and psychological dependence on, these drugs may rapidly develop with their use.  They can also produce feelings of euphoria.  As such, these narcotics have the potential to be highly addictive, and are extremely popular drugs of abuse.

Use of morphine sulfate, hydromorphone, or oxycodone may impair motor skills or judgments, making it unsafe to operate machinery, drive, or engage in other potentially dangerous activities.  Improper use of morphine sulfate, hydromorphone, or oxycodone can lead to serious illness, injury, or death.  People who overdose on narcotics may stop breathing or have a heart attack. 

Is it safe to use the unapproved products?

The safety of unapproved drugs is unknown.  Approved versions of morphine sulfate, hydromorphone, and oxycodone have labeling that has been specifically reviewed and approved by FDA, and that reflects the risks, benefits, and safe use of these drugs. This information may not be contained in the labeling of the unapproved products. 

The drug approval process enables FDA to evaluate the drug’s formulation, manufacturing process, and labeling, as well as any changes that occur after approval. 

Should I keep taking my medications?

Consumers who have concerns about their medications should speak to their healthcare professionals about replacement prescriptions. The lists of approved and unapproved high concentrate oral solutions containing morphine sulfate, and immediate release tablets containing morphine sulfate, hydromorphone, or oxycodone, are below. 

List of Approved Narcotics Drug Products: Morphine Sulfate Tablets and Solutions

Drug NDC #* NDA# Manufacturer
Morphine Sulfate Tablets 15 & 30 mg 00054 22207 Roxane
Morphine Sulfate Oral Solutions
10mg/5 ml &
20mg/5ml
00054
00054  
22195 Roxane
Morphine Sulfate Extended Release Tablets 00406 76412 Mallinckrodt
Morphine Sulfate Tablets Extended Release 60951 75295 Endo/Skyepharma

Hydromorphone Immediate Release Tablets

Drug NDC #* NDA# Manufacturer
Hydromorphone immediate release tablets – 2, 4, AND 8 mg 00074
00406
19892
78273
Abbott
Mallinckrodt

Oxycodone

Drug NDC #* NDA# Manufacturer
Oxycodone immediate release tablets – 5, 10, 15, and 30 mg 00406 76758 Mallinckrodt
Oxycodone immediate release tablets, 5, 15, and 30 mg 00254 77-712 Vintage
Oxycodone Extended Release Tablets, 10 mg 59011 20-553
75923
Purdue
Endo
Oxycodone Extended Release Tablets, 15 mg 59011 20553 Purdue
Oxycodone Extended Release Tablets, 20 and 40 mg 59011 20553 Purdue

* 5-digit Labeler Code of the NDC number  

 

List of Unapproved Narcotics Drug Products Subject to Warning Letters

Firms Products
Mallinckrodt Inc. Pharmaceuticals Group Morphine Sulfate Concentrate Oral Solution 20mg/ml
Boehringer Ingelheim Roxane Inc.   Roxanol Oral Solution, 20 mg/ml;
Roxicodone Tablets, 5 mg
Roxane Laboratories, Inc. Hydromorphone Hydrochloride Tablets, 2 mg & 4 mg
Glenmark Generics Inc.
Morphine Sulfate Tablets, 15 mg & 30 mg;
Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml;
Morphine Sulfate Solution Immediate Release Oral Solution, 20mg/5ml
Lannett Company, Inc.
Morphine Sulfate Solution Immediate Release 20mg/ml;
Hydromorphone HCl Tablets, 2mg and 4mg
Lehigh Valley Technologies Inc. Morphine Sulfate Tablets, 15 mg & 30 mg;
Morphine Sulfate Solution Concentrate, 20 mg/ml
Physicians Total Care, Inc. Morphine Sulfate Immediate Release Tablets, 30 mg;
Hydromorphone Tablets, 2 mg;
Hydromorphone Hydrochloride Tablets 4 mg
Xanodyne Pharmaceuticals Inc. Roxanol Oral Solution, 20 mg/ml;
Roxicodone Tablets, 5 mg
  Cody Laboratories, Inc. Morphine Sulfate Solution Immediate Release 20mg/ml

* 5-digit Labeler Code of the NDC number