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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

Mckesson Packaging Services: Diltiazem Extended-Release Capsules Recalled for High Dissolution Rates

Agency Publication Date: April 26, 2018
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Summary

McKesson Packaging Services is recalling 14,888 cartons of Diltiazem Hydrochloride Extended-Release Capsules (120 mg, 180 mg, and 240 mg strengths). This medication is being recalled because stability testing showed the drug was dissolving too quickly, which can affect how the medication is released into the body. These prescription products were distributed nationwide across the United States in 100-count bottles.

Risk

When extended-release medications dissolve too quickly (high dissolution), it can lead to 'dose dumping' where too much medicine enters the bloodstream at once, potentially causing side effects or reducing the effectiveness of the treatment over time.

What You Should Do

  1. Check your medication bottles for the following NDC numbers: 63739-014-10 (120 mg), 63739-284-10 (180 mg), or 63739-016-10 (240 mg).
  2. Verify the lot numbers and expiration dates on the packaging: for 120 mg check lot 0115086 (Exp. 12/2018); for 180 mg check lot 0114214 (Exp. 09/2018); and for 240 mg check lot 0115087 (Exp. 12/2018).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if your medication is part of this recall.
  4. Return any unused capsules to the pharmacy where you purchased them for a refund.
  5. Contact McKesson Packaging Services or the manufacturer for further instructions regarding the return of these products.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product to pharmacy.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Diltiazem HCl Extended-Release Capsules, USP 120 mg (100-count bottle)
Model:
NDC: 63739-014-10
Recall #: D-0714-2018
Lot Numbers:
0115086 (Exp. 12/2018)
Date Ranges: Expiration Date: 12/2018
Product: Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg (100-count bottle)
Model:
NDC: 63739-284-10
Recall #: D-0715-2018
Lot Numbers:
0114214 (Exp. 09/2018)
Date Ranges: Expiration Date: 09/2018
Product: Diltiazem HCl Extended-Release Capsules, USP 240 mg (100-count bottle)
Model:
NDC: 63739-016-10
Recall #: D-0716-2018
Lot Numbers:
0115087 (Exp. 12/2018)
Date Ranges: Expiration Date: 12/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79936
Status: Resolved
Manufacturer: Mckesson Packaging Services
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 3 products (4266 cartons; 7656 cartons; 2966 cartons)
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.