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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

Spectrum Laboratory Products: Ranitidine Hydrochloride Powder Recalled for NDMA Impurity

Agency Publication Date: February 4, 2020
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Summary

Spectrum Laboratory Products is recalling several sizes of Ranitidine Hydrochloride (powder), USP, a prescription active pharmaceutical ingredient used in medications. The recall was initiated because testing detected the presence of N-Nitrosodimethylamine (NDMA), an impurity that is classified as a probable human carcinogen. This recall affects various container sizes ranging from 1 gram to 1 kilogram that were distributed to pharmacies for compounding.

Risk

The product contains NDMA, a substance that may increase the risk of cancer in humans if exposed to levels above acceptable limits over a long period of time.

What You Should Do

  1. Check your medication records or contact your pharmacist to determine if your compounded medication was prepared using Spectrum Chemical Mfg Corp. Ranitidine Hydrochloride (powder) from lot number 11E0585 with an expiration date of October 2023.
  2. If you have a prescription containing this ingredient, contact your healthcare provider or pharmacist immediately for guidance on whether to continue your treatment or switch to an alternative medication.
  3. Return any unused portions of the affected product to the pharmacy or place of purchase for a refund.
  4. Contact Spectrum Laboratory Products directly for further instructions regarding the return or disposal of the affected lot.
  5. Report any adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/medwatch or by calling 1-888-463-6332.

Your Remedy Options

๐Ÿ’ฐFull Refund

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

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

Affected Products

Product: Ranitidine Hydrochloride (powder), USP, Spectrum Chemical Mfg Corp. (1 gram)
Model:
D-0825-2020
Lot Numbers:
11E0585 (Exp. October 2023)
Date Ranges: Exp. October 2023
Product: Ranitidine Hydrochloride (powder), USP, Spectrum Chemical Mfg Corp. (5 grams)
Model:
D-0825-2020
Lot Numbers:
11E0585 (Exp. October 2023)
Date Ranges: Exp. October 2023
Product: Ranitidine Hydrochloride (powder), USP, Spectrum Chemical Mfg Corp. (25 grams)
Model:
D-0825-2020
Lot Numbers:
11E0585 (Exp. October 2023)
Date Ranges: Exp. October 2023
Product: Ranitidine Hydrochloride (powder), USP, Spectrum Chemical Mfg Corp. (100 grams)
Model:
D-0825-2020
Lot Numbers:
11E0585 (Exp. October 2023)
Date Ranges: Exp. October 2023
Product: Ranitidine Hydrochloride (powder), USP, Spectrum Chemical Mfg Corp. (500 grams)
Model:
D-0825-2020
Lot Numbers:
11E0585 (Exp. October 2023)
Date Ranges: Exp. October 2023
Product: Ranitidine Hydrochloride (powder), USP, Spectrum Chemical Mfg Corp. (1 Kilogram)
Model:
D-0825-2020
Lot Numbers:
11E0585 (Exp. October 2023)
Date Ranges: Exp. October 2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84799
Status: Resolved
Manufacturer: Spectrum Laboratory Products
Sold By: Pharmacies
Manufactured In: United States
Distributed To: Arizona, California, Florida, Georgia, New Jersey, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Wyoming

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.

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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.