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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Opium Tincture Recalled for Subpotency

Agency Publication Date: October 30, 2023
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Summary

Edenbridge Pharmaceuticals, LLC has recalled 4,548 bottles of Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine. The medication, packaged in 118 mL (4 Fl oz) bottles, is being recalled because it was found to be subpotent, meaning it contains less of the active ingredient than required. No incidents or injuries related to this recall have been reported to date.

Risk

Using subpotent medication may result in patients receiving a lower dose than intended, which could lead to ineffective treatment or potential withdrawal symptoms. If you have been taking this medication, contact your healthcare provider or pharmacist.

What You Should Do

  1. This recall affects Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, sold in 118 mL (4 Fl oz) bottles under NDC 42799-217-01.
  2. Check the bottle label for lot numbers 23ZCP1 (Expiration Date 02/22/2026) or 23ZDR1 (Expiration Date 03/09/2026).
  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 Edenbridge Pharmaceuticals, LLC 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: Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine (118 mL)
Variants: 10 mg/mL, 118 mL (4 Fl oz)
Lot Numbers:
23ZCP1 (Exp 02/22/2026)
23ZDR1 (Exp 03/09/2026)
NDC:
42799-217-01

Rx only; Manufactured for Edenbridge Pharmaceuticals, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93236
Status: Resolved
Manufacturer: Edenbridge Pharmaceuticals, LLC
Sold By: pharmacies
Manufactured In: United States
Units Affected: 4548 bottles
Distributed To: Nationwide

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.