American Health Packaging recalls Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American
American Health Packaging recalls ranitidine syrup due to detected NDMA impurity. This impurity may pose health risks. Affected lots and quantities are listed in the recall notice.
Recall notice
CGMP Deviations: Presence of NDMA impurity detected in product.
Contact the company & request your remedy
What happened, in plain English
American Health Packaging is recalling ranitidine syrup products that contain NDMA impurity. This impurity has been detected in the product and may pose health risks, so affected consumers should stop using the product. Read more at govinfonow.com/recall/37772-american-health-packaging-ranitidine-syrup-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37772-american-health-packaging-ranitidine-syrup-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0631-2020
Cite this page
“American Health Packaging Ranitidine Syrup Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37772-american-health-packaging-ranitidine-syrup-recall-ndma-impurity-risk. Based on FDA recall #D-0631-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0631-2020%22&limit=1).
Why it’s dangerous
The recall is due to the presence of NDMA impurity in the ranitidine syrup. NDMA is a potential carcinogen that has been detected in the product. This impurity may pose health risks, but the exact risk level is not clearly stated in the recall notice.
Who’s affected
People who have been prescribed ranitidine syrup by a doctor and received the recalled products are affected. Those with the specific lots and quantities listed in the recall notice are at risk.
How to tell if you have this one
Check the product label for the specific lot numbers and expiration dates listed: Lots 183723, 184278, exp 10/31/2020; Lot 187652, exp 05/31/2021; and other lots mentioned in the recall notice.
- Brand
American Health Packaging- Category
Drug
What to do — step by step
Stop Using Product
If you have the recalled ranitidine syrup, stop using it immediately.
Questions people ask
Why is this product being recalled?
The product contains NDMA impurity, which has been detected and may pose health risks.
What should I do if I have the recalled product?
Stop using the product immediately and contact American Health Packaging for further instructions.
Are there any specific lot numbers I should check?
Yes, check the product label for lot numbers like 183723, 184278, 187652, and other lots listed in the recall notice.
Contact American Health Packaging
We’ve drafted a message you can send American Health Packaging to request your refund or repair — edit it as you like.
Subject: Recall D-0631-2020 — American Health Packaging American Health Packaging Hello, I own a American Health Packaging that is covered by recall D-0631-2020 from American Health Packaging. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0631-2020 (November 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0631-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.