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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

AVKARE Inc.: Ranitidine Hydrochloride Capsules Recalled for NDMA Impurity

Agency Publication Date: October 29, 2019
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Summary

AVKARE Inc. has voluntarily recalled 8,644 bottles of Ranitidine Hydrochloride Capsules (150 mg and 300 mg) because tests found an impurity called N-nitrosodimethylamine (NDMA). These prescription medications are used to treat and prevent heartburn and stomach ulcers. The recall affects specific lot numbers sold in 500-count bottles across Colorado and Missouri. Consumers using these medications should contact their healthcare provider to discuss alternative treatments before stopping their medication.

Risk

The medication contains NDMA, which is classified as a probable human carcinogen based on laboratory testing. This impurity may increase the risk of cancer over long-term exposure, though no immediate adverse health events have been reported for this specific recall.

What You Should Do

  1. Check your prescription bottle for AVKARE Ranitidine Hydrochloride Capsules 150 mg (NDC 42291-735-50) with the following lot numbers and expiration dates: 17708 (11/30/2019), 18459 (03/31/2020), 19033 (07/31/2020), 19032 (07/31/2020), 19031 (06/30/2020), 20204 (09/30/2020), 20205 (09/30/2020), 20663 (10/31/2020), 20664 (11/30/2020), 20665 (11/30/2020), 20666 (11/30/2020), 21039 (12/31/2020), or 21920 (04/30/2021).
  2. Check your prescription bottle for AVKARE Ranitidine Hydrochloride Capsules 300 mg (NDC 42291-736-50) with the following lot numbers and expiration dates: 17709 (01/31/2020), 18460 (02/29/2020), 19853 (09/30/2020), 22362 (11/30/2020), or 22579 (11/30/2020).
  3. Contact your healthcare provider or pharmacist immediately to discuss a replacement or alternative treatment options before you stop taking the recalled medication.
  4. Return any unused product to your pharmacy to receive a refund and ensure the medication is properly handled.
  5. Contact AVKARE Inc. for further instructions regarding this recall or for questions about the return process.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

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: AVKARE Ranitidine Hydrochloride Capsules 150 mg (500 Capsules)
Model:
NDC 42291-735-50
Recall #: D-0164-2020
UPC Codes:
342291735507
Lot Numbers:
17708 (Exp. 11/30/2019)
18459 (Exp. 03/31/2020)
19033 (Exp. 07/31/2020)
19032 (Exp. 07/31/2020)
19031 (Exp. 06/30/2020)
20204 (Exp. 09/30/2020)
20205 (Exp. 09/30/2020)
20663 (Exp. 10/31/2020)
20664 (Exp. 11/30/2020)
20665 (Exp. 11/30/2020)
20666 (Exp. 11/30/2020)
21039 (Exp. 12/31/2020)
21920 (Exp. 04/30/2021)
Product: AVKARE Ranitidine Hydrochloride Capsules 300 mg (500 Capsules)
Model:
NDC 42291-736-50
Recall #: D-0165-2020
UPC Codes:
342291736504
Lot Numbers:
17709 (Exp. 01/31/2020)
18460 (Exp. 02/29/2020)
19853 (Exp. 09/30/2020)
22362 (Exp. 11/30/2020)
22579 (Exp. 11/30/2020)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84081
Status: Resolved
Manufacturer: AVKARE Inc.
Sold By: pharmacies
Manufactured In: United States
Units Affected: 2 products (7293 bottles; 1351 bottles)
Distributed To: Colorado, Missouri

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.