AVKARE Inc. recalls AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured
AVKARE recalls 150mg ranitidine capsules due to N-nitrosodimethylamine (NDMA) impurity found in the active pharmaceutical ingredient.
Lower-risk recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Contact the company & request your remedy
What happened, in plain English
AVKARE is recalling 150mg ranitidine hydrochloride capsules that contain N-nitrosodimethylamine (NDMA), a potential carcinogen. This impurity was found in the active pharmaceutical ingredient during manufacturing, which could pose health risks with long-term use. Read more at govinfonow.com/recall/37831-avkare-ranitidine-capsules-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37831-avkare-ranitidine-capsules-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0164-2020
Cite this page
“AVKARE Ranitidine Capsules Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37831-avkare-ranitidine-capsules-recall-ndma-impurity-risk. Based on FDA recall #D-0164-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0164-2020%22&limit=1).
Why it’s dangerous
The recall is for ranitidine capsules that contain N-nitrosodimethylamine (NDMA), a chemical that has been linked to cancer in some studies. This impurity was found in the active pharmaceutical ingredient during manufacturing, which could pose health risks with long-term use.
Who’s affected
People who have prescription ranitidine capsules with the specific lot numbers listed in the recall notice are affected. Those who have taken these capsules for extended periods may be at higher risk due to the NDMA impurity.
How to tell if you have this one
Check your prescription bottle for the lot numbers: 17708 through 21920. The capsules are 150mg strength, 500-count, and require a prescription.
- Brand
AVKARE- Product
AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured- 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
CO, MO
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0164-2020 | AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478; Lot 17708 Exp.11/30/2019 Lot 18459 Exp.03/31/2020 Lot 19033 Exp.07/31/2020 Lot 19032 Exp.07/31/2020 Lot 19031 Exp.06/30/2020 Lot 20204 Exp.09/30/2020 Lot 20205 Exp.09/30/2020 Lot 20663 Exp.10/31/2020 Lot 20664 Exp.11/30/2020 Lot 20665 Exp.11/30/2020 Lot 20666 Exp.11/30/2020 Lot 21039 Exp.12/31/2020 Lot 21920 Exp.04/30/2021 | 7293 bottles |
| D-0165-2020 | AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478; Lot 17709 Exp.01/31/2020 Lot 18460 Exp.02/29/2020 Lot 19853 Exp.09/30/2020 Lot 22362 Exp.11/30/2020 Lot 22579 Exp.11/30/2020 | 1351 bottles |
What to do — step by step
Check Your Capsules
Look for the lot numbers listed in the recall notice: 17708 through 21920 on the bottle.
Questions people ask
Is this product safe to use?
The recall is for specific lot numbers that contain NDMA impurity. Other lots may be safe, but the manufacturer has issued a recall for these specific batches.
How can I tell if I have the recalled product?
Check your prescription bottle for the lot numbers: 17708 through 21920. The capsules are 150mg strength, 500-count, and require a prescription.
What should I do if I have the recalled product?
The manufacturer has issued a recall for these specific lots. Check your bottle for the lot numbers and contact your healthcare provider for guidance.
Contact AVKARE
We’ve drafted a message you can send AVKARE to request your refund or repair — edit it as you like.
Subject: Recall D-0164-2020 — AVKARE AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 34 Hello, I own a AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured that is covered by recall D-0164-2020 from AVKARE. 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-0164-2020 (October 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0164-2020 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.