H.J. Harkins Recalls Ranitidine Due to NDMA Impurity
H.J. Harkins recalls Ranitidine 150 mg tablets due to CGMP deviations and the presence of NDMA impurity. Check lot numbers RAN63KG through RAN66KG.
Use caution until it’s fixed
CGMP Deviations: Presence of NDMA impurity detected in product.
Contact the company
What happened, in plain English
H.J. Harkins Company Inc dba Pharma Pac is recalling Ranitidine, 150 mg Tablets because Good Manufacturing Practice (CGMP) deviations resulted in the presence of an NDMA impurity. The recall covers specific lots distributed to physicians in California, Florida, North Carolina, and South Carolina. The record does not specify a remedy or action for consumers. Read more at govinfonow.com/recall/37489-h-j-harkins-recalls-ranitidine-due-to-ndma-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/37489-h-j-harkins-recalls-ranitidine-due-to-ndma-impurity · Updated October 11, 2026 · FDA enforcement record: FDA #D-0793-2020
Cite this page
“H.J. Harkins Recalls Ranitidine Due to NDMA Impurity.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/37489-h-j-harkins-recalls-ranitidine-due-to-ndma-impurity. Based on FDA recall #D-0793-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0793-2020%22&limit=1).
Why it’s dangerous
The product contains an NDMA impurity detected due to CGMP deviations. While the record identifies this as a Class II recall, it does not explicitly describe the specific health risks associated with NDMA exposure in this context.
Who’s affected
Individuals who were prescribed Ranitidine by physicians in California, Florida, North Carolina, or South Carolina between the manufacturing dates and expiration dates listed. This includes patients holding tablets in 7, 14, 20, 30, or 60 count bottles.
How to tell if you have this one
Look for bottles of Ranitidine, 150 mg Tablets manufactured by H.J. Harkins Company Inc dba Pharma Pac. Check the NDC numbers (52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30, or 52959-0502-60) and lot numbers RAN63KG (Exp. 05/20), RAN64KG (Exp. 10/20), RAN65KG (Exp. 11/20), or RAN66KG (Exp. 05/21).
- Brand
H.J. Harkins- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Ranitidine tablets match the recalled NDC and lot numbers listed in the record.
Consult Your Physician
Contact your doctor or pharmacist for guidance on what to do with the medication, as no specific remedy is stated in the recall record.
Where it went and when
Where it was distributed
Distributed in 4 states.
FDA distribution: “Distributed to Physicians in the following states: CA, FL, NC, and SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, North Carolina, South Carolina.
Recall timeline
FDA terminated this recall 3.9 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0793-2020 (January 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0793-2020 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.