Appco Pharma LLC recalls Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854,
Appco Pharma recalls 300mg Ranitidine Capsules due to potential NDMA impurity. Rx-only capsules manufactured in Piscataway, NJ with batch numbers 1905227UE and 1905228UE.
Recall notice
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Contact the company & request your remedy
What happened, in plain English
Appco Pharma is recalling 300mg Ranitidine Capsules (30-count bottles) that were manufactured with a chemical impurity called NDMA. This impurity could pose health risks, especially for people with certain medical conditions. Read more at govinfonow.com/recall/37484-appco-pharma-recalls-ranitidine-capsules-300mg-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37484-appco-pharma-recalls-ranitidine-capsules-300mg-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0648-2020
Cite this page
“Appco Pharma recalls Ranitidine Capsules 300mg: NDMA impurity risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37484-appco-pharma-recalls-ranitidine-capsules-300mg-ndma-impurity-risk. Based on FDA recall #D-0648-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0648-2020%22&limit=1).
Why it’s dangerous
The capsules were found to contain N-nitrosodimethylamine (NDMA), a chemical impurity that can form in some medications. While NDMA is present in trace amounts in some foods, higher levels in medication could potentially cause health issues, especially for people with certain medical conditions.
Who’s affected
People who have prescription Ranitidine Capsules 300mg, 30-count bottles manufactured by Appco Pharma in Piscataway, NJ with batch numbers 1905227UE or 1905228UE are affected. Those with specific health conditions may be at higher risk.
How to tell if you have this one
Check for Ranitidine Capsules 300mg, 30-count bottles with batch numbers 1905227UE or 1905228UE. These were manufactured by Appco Pharma in Piscataway, NJ and distributed by ANI Pharmaceuticals in Baudette, MN.
- Brand
Appco Pharma- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0648-2020 | Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.; Batch # 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-2021 | 1,632 bottes |
| D-0649-2020 | Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.; Batch # 1905225VN, exp. date Apr-2021 1905226VD, exp. date Apr-2021 1906295UN, exp. date May-2021 1906296UN, exp. date May-2021 1906297UN, exp. date May-2021 1906298UD, exp. date May-2021 | 624 bottes |
What to do — step by step
Check Product Details
Look for batch numbers 1905227UE or 1905228UE on the product label.
Questions people ask
Is this product safe to use?
The recall states that the capsules were found to contain NDMA, a chemical impurity that could pose health risks, but the official notice does not specify if the product is safe to use.
What should I do if I have this product?
The recall record does not specify any remedy or action steps for affected products.
How can I confirm if my product is recalled?
Check for batch numbers 1905227UE or 1905228UE on the product label. These were manufactured by Appco Pharma in Piscataway, NJ and distributed by ANI Pharmaceuticals in Baudette, MN.
Contact Appco Pharma
We’ve drafted a message you can send Appco Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0648-2020 — Appco Pharma Appco Pharma Hello, I own a Appco Pharma that is covered by recall D-0648-2020 from Appco Pharma. 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-0648-2020 (January 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0648-2020 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.