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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

PD-Rx Pharmaceuticals, Inc.: Ranitidine 150 mg Tablets Recalled for Potential NDMA Contamination

Agency Publication Date: February 4, 2020
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Summary

PD-Rx Pharmaceuticals, Inc. is recalling various bottle sizes of ranitidine hydrochloride USP, 150 mg tablets due to potential contamination with N-nitrosodimethylamine (NDMA) at levels higher than allowed by the FDA. Ranitidine is a prescription medication commonly used to treat and prevent ulcers in the stomach and intestines, as well as gastroesophageal reflux disease (GERD). This recall was initiated after the supplier notified the company that the drug may contain this impurity, which is classified as a probable human carcinogen. Consumers who have these tablets should contact their healthcare provider or pharmacist to discuss alternative treatments.

Risk

The product may contain N-nitrosodimethylamine (NDMA), a substance classified as a probable human carcinogen that can cause cancer with long-term exposure. While no immediate injuries have been reported, the levels of NDMA detected may exceed safety limits established by health authorities.

What You Should Do

  1. Check your medication bottles for 'ranitidine hydrochloride, USP 150 mg tablets' with NDC numbers 43063-844-14, 43063-844-30, 43063-844-60, 43063-844-90, or 43063-844-01.
  2. Verify if your bottle matches the following lot numbers and expiration dates: H19E83 (11/30/2020), E19A82 (05/31/2020), H19B20 (11/30/2020), G19D77 (05/31/2020), C19D84 (05/31/2020), D19A77 (05/31/2020), D19E40 (05/31/2020), I19C45 (11/30/2020), E19E42 (11/30/2020), G19B41 (11/30/2020), H19C77 (11/30/2020), E19A34 (05/31/2020), H19B61 (11/30/2020), H19C82 (11/30/2020), C19A18 (05/31/2020), C19B13 (05/31/2020), D19B77 (05/31/2020), E19B76 (05/31/2020), I19B41 (11/30/2020), D19D51 (05/31/2020), or F19C33 (05/31/2020).
  3. Contact your healthcare provider or pharmacist immediately to discuss an alternative treatment before you stop taking this medication.
  4. Return any unused tablets to the pharmacy where you purchased them for a refund.
  5. Contact PD-Rx Pharmaceuticals, Inc. at their Oklahoma City location for further instructions regarding the return of affected products.
  6. For additional questions, 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

Full refund upon return of product.

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, USP, 150 mg tablets (14-count bottles)
Model:
NDC 43063-844-14
Lot Numbers:
H19E83 (Exp. 11/30/2020)
E19A82 (Exp. 05/31/2020)
Date Ranges: Exp. 11/30/2020, Exp. 05/31/2020
Product: ranitidine hydrochloride, USP, 150 mg tablets (30-count bottles)
Model:
NDC 43063-844-30
Lot Numbers:
H19B20 (Exp. 11/30/2020)
G19D77 (Exp. 05/31/2020)
C19D84 (Exp. 05/31/2020)
D19A77 (Exp. 05/31/2020)
D19E40 (Exp. 05/31/2020)
Date Ranges: Exp. 11/30/2020, Exp. 05/31/2020
Product: ranitidine hydrochloride, USP, 150 mg tablets (60-count bottles)
Model:
NDC 43063-844-60
Lot Numbers:
I19C45 (Exp. 11/30/2020)
E19E42 (Exp. 11/30/2020)
G19B41 (Exp. 11/30/2020)
H19C77 (Exp. 11/30/2020)
E19A34 (Exp. 05/31/2020)
Date Ranges: Exp. 11/30/2020, Exp. 05/31/2020
Product: ranitidine hydrochloride, USP, 150 mg tablets (90-count bottles)
Model:
NDC 43063-844-90
Lot Numbers:
H19B61 (Exp. 11/30/2020)
H19C82 (Exp. 11/30/2020)
C19A18 (Exp. 05/31/2020)
C19B13 (Exp. 05/31/2020)
D19B77 (Exp. 05/31/2020)
E19B76 (Exp. 05/31/2020)
Date Ranges: Exp. 11/30/2020, Exp. 05/31/2020
Product: ranitidine hydrochloride, USP, 150 mg tablets (100-count bottles)
Model:
NDC 43063-844-01
Lot Numbers:
I19B41 (Exp. 11/30/2020)
D19D51 (Exp. 05/31/2020)
F19C33 (Exp. 05/31/2020)
Date Ranges: Exp. 11/30/2020, Exp. 05/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84820
Status: Resolved
Manufacturer: PD-Rx Pharmaceuticals, Inc.
Sold By: Pharmacies; Healthcare providers
Manufactured In: United States
Distributed To: Arizona, California, Florida, Illinois, Indiana, Kentucky, Maine, Mississippi, Oklahoma, Oregon, Pennsylvania, Tennessee

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.