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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Dexamethasone Elixir Recalled for Higher Than Permissible Impurities

Agency Publication Date: February 25, 2022
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Summary

Morton Grove Pharmaceuticals, Inc. has voluntarily recalled five lots of Dexamethasone Elixir, USP (0.5 mg/5 mL) packaged in 8 fl oz bottles. This recall was issued because laboratory testing discovered unknown impurities at levels higher than what is permitted for this medication. While no injuries or incidents have been reported to date, using medication with unexpected impurities could affect the drug's safety or how well it works.

Risk

The product failed impurities and degradation specifications, meaning the drug contains unknown substances that should not be present at these levels. This poses a potential health risk to patients relying on the medication for treatment.

What You Should Do

  1. The recalled products are 8 fl oz (237 mL) bottles of Dexamethasone Elixir, USP 0.5 mg/5 mL (NDC 60432-466-08) manufactured by Morton Grove Pharmaceuticals, Inc.
  2. Check the bottle label for the following lot numbers and expiration dates: UV1004 or UV1005 (Exp 6/22); UW1014 or UW1015 (Exp 1/23); or UW1084 (Exp 7/23).
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Morton Grove Pharmaceuticals for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dexamethasone Elixir, USP 0.5 mg/5 mL (8 fl oz)
Variants: 0.5 mg/5 mL, 8 fl oz (237 mL) bottle
Lot Numbers:
UV1004 (Exp 6/22)
UV1005 (Exp 6/22)
UW1014 (Exp 1/23)
UW1015 (Exp 1/23)
UW1084 (Exp 7/23)
NDC:
60432-466-08

Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89624
Status: Resolved
Manufacturer: Morton Grove Pharmaceuticals, Inc.
Sold By: pharmacies
Manufactured In: United States
Distributed To: Nationwide
Agency Last Updated: March 21, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.