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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

AVKARE Inc.: Ranitidine Tablets Recalled Due to NDMA Impurity

Agency Publication Date: November 26, 2019
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Summary

AVKARE Inc. has recalled approximately 735,935 bottles of Ranitidine Tablets (both 150 mg and 300 mg strengths), a medication used to treat stomach acid conditions. The recall was initiated because the tablets may contain an impurity called N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. These prescription-only medications were distributed nationwide in various bottle sizes ranging from 30 to 1000 tablets. Consumers should check their prescription bottles against the specific lot numbers and expiration dates to determine if their medication is affected.

Risk

The medication contains NDMA, an environmental contaminant found in water and foods. While it may be present in low levels, the levels found in these specific lots of Ranitidine exceed acceptable safety limits, and long-term exposure to high levels of NDMA is linked to an increased risk of cancer.

What You Should Do

  1. Check your Ranitidine 150 mg prescription bottle for NDC 42291-724-10 (1000ct), 42291-724-18 (180ct), or 42291-724-60 (60ct). Affected lot numbers for 150 mg include HK16617A, HL03917A, HL04017A, HM06017A, HM06117A, HB03518A, HB03618A, HC14018A, HC14118A, HC14218A, HC14318A, HC14418A, HC14518A, HH04518A, HH04618A, HH04718A, HH04818A, HH04918A, HK02718A, HK06918A, HL07418A, HL07518A, HA00419A, HA00519A, HA02719A, HA02819A, HA2719A, HC05019A, HC05119A, HC05911A, HE03319A, HE03419A, HE05419A, HG02319A, HG02419A, HG02619A, 21570, 21571, 22190, 22192, 22497, 22620, 22999, 23000, 24158, 24159, 21241, 21680, 22193, 22657, 23001, 23002, and 24157.
  2. Check your Ranitidine 300 mg prescription bottle for NDC 42291-725-25 (250ct) or 42291-725-30 (30ct). Affected lot numbers for 300 mg include 21307, 21309, 21528, 21527, 22247, 23214, 23243, 23244, 24198, 24199, 24289, 22291, 23215, and 23776.
  3. Identify the expiration date on your bottle; affected 150 mg and 300 mg lots have expiration dates ranging from November 30, 2019, through June 30, 2021.
  4. Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment before you stop taking the medication, as stopping acid-reducing medication abruptly can cause health complications.
  5. Return any unused tablets to your pharmacy for a refund and contact AVKARE Inc. at their Pulaski, TN headquarters for further guidance regarding the recall process.
  6. For additional questions or to report adverse reactions, 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

Drug recall refund/return

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 Tablets, USP 150 mg Rx Only (1000 tablets)
Model:
NDC 42291-724-10
Lot Numbers:
HK16617A (Exp. 11/30/2019)
HL03917A (Exp. 11/30/2019)
HL04017A (Exp. 11/30/2019)
HM06017A (Exp. 11/30/2019)
HM06117A (Exp. 11/30/2019)
HB03518A (Exp. 03/31/2020)
HB03618A (Exp. 03/31/2020)
HC14018A (Exp. 04/30/2020)
HC14118A (Exp. 04/30/2020)
HC14218A (Exp. 04/30/2020)
HC14318A (Exp. 04/30/2020)
HC14418A (Exp. 04/30/2020)
HC14518A (Exp. 05/31/2020)
HH04518A (Exp. 08/31/2020)
HH04618A (Exp. 08/31/2020)
HH04718A (Exp. 08/31/2020)
HH04818A (Exp. 08/31/2020)
HH04918A (Exp. 08/31/2020)
HK02718A (Exp. 10/31/2020)
HK06918A (Exp. 10/31/2020)
HL07418A (Exp. 11/30/2020)
HL07518A (Exp. 11/30/2020)
HA00419A (Exp. 12/31/2020)
HA00519A (Exp. 12/31/2020)
HA02719A (Exp. 12/31/2020)
HA02819A (Exp. 12/31/2020)
HA2719A (Exp. 12/31/2020)
HC05019A (Exp. 03/31/2021)
HC05119A (Exp. 03/31/2021)
HC05911A (Exp. 03/31/2021)
HE03319A (Exp. 04/30/2021)
HE03419A (Exp. 04/30/2021)
HE05419A (Exp. 04/30/2021)
HG02319A (Exp. 06/30/2021)
HG02419A (Exp. 06/30/2021)
HG02619A (Exp. 06/30/2021)
Date Ranges: Exp. 11/30/2019 - 06/30/2021
Product: AVKARE Ranitidine Tablets, USP 150 mg Rx Only (180 tablets)
Model:
NDC 42291-724-18
Lot Numbers:
21570 (Exp. 03/31/2020)
21571 (Exp. 03/31/2020)
22190 (Exp. 03/31/2020)
22192 (Exp. 05/31/2020)
22497 (Exp. 05/31/2020)
22620 (Exp. 05/31/2020)
22999 (Exp. 09/30/2020)
23000 (Exp. 09/30/2020)
24158 (Exp. 03/31/2021)
24159 (Exp. 04/30/2021)
Date Ranges: Exp. 03/31/2020 - 04/30/2021
Product: AVKARE Ranitidine Tablets, USP 150 mg Rx Only (60 tablets)
Model:
NDC 42291-724-60
Lot Numbers:
21241 (Exp. 03/31/2020)
21680 (Exp. 03/31/2020)
22193 (Exp. 03/31/2020)
22657 (Exp. 03/31/2020)
23001 (Exp. 09/30/2020)
23002 (Exp. 09/30/2020)
24157 (Exp. 04/30/2021)
Date Ranges: Exp. 03/31/2020 - 04/30/2021
Product: AVKARE Ranitidine Tablets, USP 300 mg Rx Only (250 tablets)
Model:
NDC 42291-725-25
Lot Numbers:
21307 (Exp. 02/29/2020)
21309 (Exp. 02/29/2020)
21528 (Exp. 02/29/2020)
21527 (Exp. 02/29/2020)
22247 (Exp. 06/30/2020)
23214 (Exp. 09/30/2020)
23243 (Exp. 09/30/2020)
23244 (Exp. 11/30/2020)
24198 (Exp. 01/31/2021)
24199 (Exp. 01/31/2021)
24289 (Exp. 01/31/2021)
Date Ranges: Exp. 02/29/2020 - 01/31/2021
Product: AVKARE Ranitidine Tablets, USP 300 mg Rx Only (30 tablets)
Model:
NDC 42291-725-30
Lot Numbers:
22291 (Exp. 06/30/2020)
23215 (Exp. 09/30/2020)
23776 (Exp. 01/31/2021)
Date Ranges: Exp. 06/30/2020 - 01/31/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84287
Status: Resolved
Manufacturer: AVKARE Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (631,138 bottles; 104,797 bottles)
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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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.