AVKARE Inc. recalls AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal
AVKARE recalls 1000, 180, and 60-count ranitidine tablets with impurity N-nitrosodimethylamine (NDMA) that may pose health risks. Consumers should check NDC numbers and expiration dates.
Recall notice
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Contact the company & request your remedy
What happened, in plain English
AVKARE is recalling ranitidine tablets that contain a harmful impurity called N-nitrosodimethylamine (NDMA). This impurity may pose health risks, so affected consumers should stop using these products and contact the manufacturer for details. Read more at govinfonow.com/recall/37696-avkare-ranitidine-tablets-recall-impurity-n-nitrosodimethylamine-found.
Source Summary by GovInfoNow · govinfonow.com/recall/37696-avkare-ranitidine-tablets-recall-impurity-n-nitrosodimethylamine-found · Updated October 5, 2026 · FDA enforcement record: FDA #D-0524-2020
Cite this page
“AVKARE Ranitidine Tablets Recall: Impurity N-nitrosodimethylamine Found.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37696-avkare-ranitidine-tablets-recall-impurity-n-nitrosodimethylamine-found. Based on FDA recall #D-0524-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0524-2020%22&limit=1).
Why it’s dangerous
The tablets contain N-nitrosodimethylamine (NDMA), a chemical that has been linked to potential health risks. While the exact risk level isn't specified in the recall, the presence of this impurity is concerning for consumer safety.
Who’s affected
People who have the recalled ranitidine tablets (1000, 180, or 60-count sizes) manufactured by Amneal Pharmaceuticals in Pulaski, TN. Those who have taken these tablets recently may be at risk due to the impurity.
How to tell if you have this one
Check for NDC numbers: 42291-724-10 (1000 tablets), 42291-724-18 (180 tablets), or 42291-724-60 (60 tablets). Also look for expiration dates listed in the recall details.
- Brand
AVKARE- 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
Nationwide.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0524-2020 | AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60; Lots: a) HK16617A Exp. 11/30/2019, HL03917A Exp. 11/30/2019, HL04017A Exp. 11/30/2019, HM06017A Exp. 11/30/2019, HM06117A Exp. 11/30/2019, HB03518A Exp. 03/31/2020, HB03618A Exp. 03/31/2020, HC14018A Exp. 04/30/2020, HC14118A Exp. 04/30/2020, HC14218A Exp. 04/30/2020, HC14318A Exp. 04/30/2020, HC14418A Exp. 04/30/2020, HC14518A Exp. 05/31/2020, HH04518A Exp. 08/31/2020, HH04618A Exp. 08/31/2020, HH04718A Exp. 08/31/2020, HH04818A Exp. 08/31/2020, HH04918A Exp. 08/31/2020, HK02718A Exp. 10/31/2020, HK06918A Exp. 10/31/2020, HL07418A Exp. 11/30/2020, HL07518A Exp. 11/30/2020, HA00419A Exp. 12/31/2020, HA00519A Exp. 12/31/2020, HA02719A Exp. 12/31/2020, HA02819A Exp. 12/31/2020, HA2719A Exp. 12/31/2020, HC05019A Exp. 03/31/2021, HC05119A Exp. 03/31/2021, HC05911A Exp. 03/31/2021, HE03319A Exp. 04/30/2021, HE03419A Exp. 04/30/2021, HE05419A Exp. 04/30/2021, HG02319A Exp. 06/30/2021, HG02419A Exp. 06/30/2021, HG02619A Exp. 06/30/2021; b) 21570 Exp. 03/31/2020, 21571 Exp. 03/31/2020, 22190 Exp. 03/31/2020, 22192 Exp. 05/31/2020, 22497 Exp. 05/31/2020, 22620 Exp. 05/31/2020, 22999 Exp. 09/30/2020, 23000 Exp. 09/30/2020, 24158 Exp. 03/31/2021, 24159 Exp. 04/30/2021; c) 21241 Exp. 03/31/2020, 21680 Exp. 03/31/2020, 22193 Exp. 03/31/2020, 22657 Exp. 03/31/2020, 23001 Exp. 09/30/2020, 23002 Exp. 09/30/2020, 24157 Exp. 04/30/2021 | 631,138 bottles |
| D-0525-2020 | AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30; Lots: a) 21307 Exp. 02/29/2020, 21309 Exp. 02/29/2020, 21528 Exp. 02/29/2020, 21527 Exp. 02/29/2020, 22247 Exp. 06/30/2020, 23214 Exp. 09/30/2020, 23243 Exp. 09/30/2020, 23244 Exp. 11/30/2020, 24198 Exp. 01/31/2021, 24199 Exp. 01/31/2021, 24289 Exp. 01/31/2021; b) 22291 Exp. 06/30/2020, 23215 Exp. 09/30/2020, 23776 Exp. 01/31/2021 | 104,797 bottles |
What to do — step by step
Check Product Details
Identify the NDC number and expiration date on your ranitidine tablets to confirm if they are part of the recall.
Questions people ask
Why is this product being recalled?
The product contains N-nitrosodimethylamine (NDMA), a chemical that has been linked to potential health risks. The manufacturer is recalling it due to CGMP deviations.
What should I do if I have the recalled product?
Check the NDC number and expiration date on your ranitidine tablets. If they match the recalled items, stop using them and contact AVKARE for further instructions.
Is there a remedy for this recall?
The recall record does not specify a remedy. Consumers should check the product details and contact AVKARE if they have the recalled items.
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-0524-2020 — AVKARE AVKARE Hello, I own a AVKARE that is covered by recall D-0524-2020 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-0524-2020 (November 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0524-2020 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.