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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

Appco Pharma LLC: Ranitidine Capsules Recalled for Potential Carcinogen Impurity (NDMA)

Agency Publication Date: January 7, 2020
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Summary

Appco Pharma LLC has recalled 2,256 bottles of Ranitidine capsules, a prescription medication used to treat stomach acid conditions. The recall affects both 150 mg and 300 mg strengths packaged in 30, 60, and 500-count bottles. This action was taken because testing detected N-nitrosodimethylamine (NDMA), a substance classified as a probable human carcinogen, at levels that deviate from manufacturing standards. Consumers should contact their healthcare provider or pharmacist to discuss alternative treatments and instructions for returning the product.

Risk

The drug contains NDMA, an impurity that is classified as a probable human carcinogen based on laboratory testing. While low levels of NDMA are common in some foods and water, high exposure over time may increase the risk of cancer.

What You Should Do

  1. Check your prescription bottle for Ranitidine Capsules 300 mg (30-count) with NDC 62559-691-30, identifying batch numbers 1905227UE or 1905228UE with an expiration date of April 2021.
  2. Check your prescription bottle for Ranitidine Capsules 150 mg (60-count or 500-count) with NDC 62559-690-60 or 62559-690-05, identifying batch numbers 1905225VN, 1905226VD, 1906295UN, 1906296UN, 1906297UN, or 1906298UD with expiration dates in April or May 2021.
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment options and obtain a replacement prescription before you stop taking this medication.
  4. Return any remaining affected medication to the pharmacy where it was purchased for a refund and contact Appco Pharma LLC for further instructions.
  5. Report any adverse reactions or quality problems to the FDA's MedWatch program online or by calling the FDA Consumer Complaint hotline at 1-888-723-3332.

Your Remedy Options

💰Full Refund

Healthcare consultation and pharmaceutical 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 Capsules 300 mg (30 count bottles)
Model:
NDC 62559-691-30
Recall #: D-0648-2020
Lot Numbers:
1905227UE (Exp Apr-2021)
1905228UE (Exp Apr-2021)
Date Ranges: April 2021
Product: Ranitidine Capsules 150 mg (60 count bottles)
Model:
NDC 62559-690-60
Recall #: D-0649-2020
Lot Numbers:
1905225VN (Exp Apr-2021)
1905226VD (Exp Apr-2021)
1906295UN (Exp May-2021)
1906296UN (Exp May-2021)
1906297UN (Exp May-2021)
1906298UD (Exp May-2021)
Date Ranges: April 2021, May 2021
Product: Ranitidine Capsules 150 mg (500 count bottles)
Model:
NDC 62559-690-05
Recall #: D-0649-2020
Lot Numbers:
1905225VN (Exp Apr-2021)
1905226VD (Exp Apr-2021)
1906295UN (Exp May-2021)
1906296UN (Exp May-2021)
1906297UN (Exp May-2021)
1906298UD (Exp May-2021)
Date Ranges: April 2021, May 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84610
Status: Resolved
Manufacturer: Appco Pharma LLC
Sold By: ANI Pharmaceuticals, Inc.; Distributors; Wholesalers
Manufactured In: United States
Units Affected: 2 products (1,632 bottes; 624 bottes)
Distributed To: Nationwide

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 · 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.