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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

Amneal Pharmaceuticals, Inc.: Ranitidine Tablets and Syrup Recalled for Cancer-Causing Impurity NDMA

Agency Publication Date: December 10, 2019
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Summary

Amneal Pharmaceuticals has voluntarily recalled several strengths and sizes of Ranitidine Tablets (150 mg and 300 mg) and Ranitidine Syrup Oral Solution (15 mg/mL) because testing discovered an impurity called N-nitrosodimethylamine (NDMA) in the active ingredient. Ranitidine is a common medication used to treat stomach ulcers and heartburn. The recall includes various bottle sizes ranging from 30-count to 1000-count bottles sold nationwide between 2019 and 2021. Consumers should contact their doctor or pharmacist immediately to discuss alternative treatments, as this medication may contain a substance classified as a probable human carcinogen.

Risk

The recalled products contain N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. While NDMA is a known environmental contaminant found in water and foods, its presence in medication at levels higher than acceptable limits poses an increased risk of cancer over long-term exposure.

What You Should Do

  1. Check your medication packaging for 'Ranitidine Tablets, USP' (150 mg or 300 mg) or 'Ranitidine Syrup Oral Solution' (15 mg/mL) and look for the manufacturer name 'Amneal Pharmaceuticals' or 'Apotheca' (linked to NDC 53746).
  2. Verify if your bottle's NDC (National Drug Code) matches one of the following: 65162-253-06, 65162-253-10, 65162-253-18, 65162-253-50, 65162-253-11, 65162-254-30, 65162-254-10, 65162-254-25, 65162-664-90, 53746-253-10, or 53746-254-02.
  3. Check the lot number and expiration date on the side of the bottle; affected lots include numerous codes such as AR171764A (Exp 11/2019), AR180020C (Exp 1/2020), AR190366B (Exp 2/2021), HB03718A (Exp 3/2020), and others spanning expiration dates from November 2019 through May 2021.
  4. Contact your healthcare provider or pharmacist immediately to obtain an alternative treatment before you stop taking this medication.
  5. Once an alternative treatment is secured, return any unused product to the pharmacy where it was purchased for a refund and to ensure proper disposal.
  6. Contact Amneal Pharmaceuticals at 1-888-723-3332 for more information regarding the return process.
  7. For additional questions or to report adverse effects, contact the FDA Consumer Complaint hotline at 1-888-SAFEFDA (1-888-723-3332) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund and guidance for alternative medication.

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

Affected Products

Product: Ranitidine Tablets, USP 150 mg (60, 100, 180, 500, 1000-count bottles)
Model:
NDC 65162-253-06
NDC 65162-253-10
NDC 65162-253-18
NDC 65162-253-50
NDC 65162-253-11
Lot Numbers (135):
AR171764A (Exp 11/2019)
AR171875A (Exp 11/2019)
AR171876A (Exp 11/2019)
AR171981A (Exp 11/2019)
AR180020C (Exp 1/2020)
AR180206A (Exp 1/2020)
AR180207A (Exp 1/2020)
AR180208A (Exp 1/2020)
AR180438A (Exp 2/2020)
AR180439A (Exp 2/2020)
AR180481A (Exp 3/2020)
AR180482A (Exp 3/2020)
AR180483A (Exp 3/2020)
AR181690A (Exp 10/2020)
AR181691A (Exp 10/2020)
AR181806A (Exp 11/2020)
AR190058A (Exp 12/2020)
AR190059A (Exp 12/2020)
AR190183A (Exp 1/2021)
AR190184A (Exp 1/2021)
AR171984A (Exp 12/2019)
AR180020B (Exp 1/2020)
AR180675A (Exp 4/2020)
AR180868B (Exp 5/2020)
AR181807A (Exp 11/2020)
AR190366B (Exp 2/2021)
AR171986A (Exp 12/2019)
AR171987A (Exp 12/2019)
AR180255A (Exp 1/2020)
AR180441A (Exp 2/2020)
AR180442A (Exp 2/2020)
AR180559A (Exp 3/2020)
AR180560A (Exp 3/2020)
AR180594A (Exp 3/2020)
AR180595A (Exp 3/2020)
AR180829A (Exp 4/2020)
AR180831A (Exp 5/2020)
AR180832A (Exp 5/2020)
AR180868A (Exp 5/2020)
AR181807C (Exp 11/2020)
AR190085A (Exp 12/2020)
AR190086A (Exp 12/2020)
AR190087A (Exp 12/2020)
AR190124A (Exp 1/2021)
AR190542B (Exp 3/2021)
AR190609A (Exp 3/2021)
AR190610A (Exp 3/2021)
AR171875B (Exp 11/2019)
AR180483B (Exp 3/2020)
AR181807B (Exp 11/2020)
Date Ranges: Exp dates between 11/2019 and 03/2021
Product: Ranitidine Tablets, USP 300 mg (30, 100, 250-count bottles)
Model:
NDC 65162-254-30
NDC 65162-254-10
NDC 65162-254-25
Lot Numbers (102):
AR172033B (Exp 11/2019)
AR180024A (Exp 12/2019)
AR180025A (Exp 12/2019)
AR180118A (Exp 12/2019)
AR180119A (Exp 12/2019)
AR180519A (Exp 3/2020)
AR180615A (Exp 3/2020)
AR181795A (Exp 11/2020)
AR181921B (Exp 12/2020)
AR190705A (Exp 4/2021)
AR172029A (Exp 11/2019)
AR172030A (Exp 11/2019)
AR180021A (Exp 12/2019)
AR180022A (Exp 12/2019)
AR180023A (Exp 12/2019)
AR180123A (Exp 12/2019)
AR180144A (Exp 1/2020)
AR180145A (Exp 1/2020)
AR180146A (Exp 1/2020)
AR180147A (Exp 1/2020)
AR180402A (Exp 2/2020)
AR180465A (Exp 2/2020)
AR180466A (Exp 2/2020)
AR180467A (Exp 2/2020)
AR180468A (Exp 2/2020)
AR180613A (Exp 3/2020)
AR181156A (Exp 7/2020)
AR181157A (Exp 7/2020)
AR190418B (Exp 2/2021)
AR171800A (Exp 11/2019)
AR171801A (Exp 11/2019)
AR171802A (Exp 11/2019)
AR171803A (Exp 11/2019)
AR171804A (Exp 11/2019)
AR171931A (Exp 11/2019)
AR171932A (Exp 11/2019)
AR171933A (Exp 11/2019)
AR171934A (Exp 11/2019)
AR171935A (Exp 11/2019)
AR171936A (Exp 11/2019)
AR171937A (Exp 11/2019)
AR172026A (Exp 11/2019)
AR172027A (Exp 11/2019)
AR172028A (Exp 11/2019)
AR172031A (Exp 11/2019)
AR172032A (Exp 11/2019)
AR172033A (Exp 11/2019)
AR172034A (Exp 11/2019)
AR172035A (Exp 11/2019)
AR180030A (Exp 12/2019)
Date Ranges: Exp dates between 11/2019 and 04/2021
Product: Ranitidine Syrup Oral Solution 15 mg/mL (473 mL)
Model:
NDC 65162-664-90
Lot Numbers:
06648001A (Exp 11/2019)
06648003A (Exp 4/2020)
06649001A (Exp 1/2021)
Date Ranges: Exp dates between 11/2019 and 01/2021
Product: Ranitidine Tablets, USP 150 mg (1000-count bottle)
Model:
NDC 53746-253-10
Lot Numbers:
HB03718A (Exp 3/2020)
HB03818A (Exp 3/2020)
HB03918A (Exp 3/2020)
HB04018A (Exp 3/2020)
HC01618A (Exp 3/2020)
HC14618A (Exp 5/2020)
HC14718A (Exp 5/2020)
HC14818A (Exp 5/2020)
HC14918A (Exp 5/2020)
HC15018A (Exp 5/2020)
HK02318A (Exp 9/2020)
HK02418A (Exp 9/2020)
HK02518A (Exp 9/2020)
HK02618A (Exp 9/2020)
HD03119A (Exp 3/2021)
HD03219A (Exp 3/2021)
HE03119A (Exp 4/2021)
HE03219A (Exp 4/2021)
Date Ranges: Exp dates between 03/2020 and 04/2021
Product: Ranitidine Tablets, USP 300 mg (250-count bottle)
Model:
NDC 53746-254-02
Lot Numbers:
HB04118A (Exp 2/2020)
HB04218A (Exp 2/2020)
HB04318A (Exp 2/2020)
HB04418A (Exp 2/2020)
HF13518A (Exp 6/2020)
HF13618A (Exp 6/2020)
HF13718A (Exp 6/2020)
HF13818A (Exp 6/2020)
HK02818A (Exp 9/2020)
HK02918A (Exp 9/2020)
HK03018A (Exp 9/2020)
HK03118A (Exp 9/2020)
HL08418A (Exp 11/2020)
HL08518A (Exp 11/2020)
HL08618A (Exp 11/2020)
HL08718A (Exp 11/2020)
HB01419A (Exp 1/2021)
HB05619A (Exp 1/2021)
HB05719A (Exp 1/2021)
HB05819A (Exp 1/2021)
HB05919A (Exp 1/2021)
HB06019A (Exp 1/2021)
HB06119A (Exp 1/2021)
Date Ranges: Exp dates between 02/2020 and 01/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84353
Status: Active
Manufacturer: Amneal Pharmaceuticals, Inc.
Sold By: Retail Pharmacies
Manufactured In: United States
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.