AAA Pharmaceutical, Inc. recalls Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
AAA Pharmaceutical recalls 150 mg Ranitidine tablets (24 count) with NDMA impurity found in manufacturing. Consumers should stop using these products immediately.
Stop using this now
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Contact the company & request your remedy
What happened, in plain English
AAA Pharmaceutical is recalling 150 mg Ranitidine tablets (24 count) because impurities called NDMA were found during production. This impurity may pose a health risk, so affected consumers should stop using these products. Read more at govinfonow.com/recall/37493-aaa-pharmaceutical-recalls-ranitidine-tablets-due-to-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37493-aaa-pharmaceutical-recalls-ranitidine-tablets-due-to-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0645-2020
Cite this page
“AAA Pharmaceutical recalls Ranitidine tablets due to NDMA impurity risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37493-aaa-pharmaceutical-recalls-ranitidine-tablets-due-to-ndma-impurity-risk. Based on FDA recall #D-0645-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0645-2020%22&limit=1).
Why it’s dangerous
The recall is due to the presence of N-nitrosodimethylamine (NDMA), a potential carcinogen, found in the manufacturing process of these tablets. This impurity can form during the production of ranitidine and may pose health risks with long-term use.
Who’s affected
People who own or use the recalled Ranitidine 150 mg tablets (24 count) with NDC 37808-196-01 are affected. Those with health conditions that increase sensitivity to impurities may be at higher risk.
How to tell if you have this one
Check for the product name 'Ranitidine 150 mg tablets, 24 count' with NDC code 37808-196-01. These were sold under various batch numbers from August 2020 to April 2021.
- Brand
AAA Pharmaceutical- 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 one consignee who may have distributed the product further to their retail stores.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0645-2020 | Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.; P134458, Sept 2020 P134943, Aug 2020 P135840, Aug, 2020 P136622, April 2021 P136871, April 2021 P137347, April 2021 P137424, April 2021 | 34,272 (24-count bottles) |
| D-0646-2020 | Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.; P134457, Sept 2020 P135156, Aug 2020 P135156, Aug 2020 P135243, Aug 2020 P135877, Sept 2020 P136145, Aug 2020 P136146, Sept 2020 P136623, April 2021 P136728, April, 2021 P136994, April, 2021 P137348, April, 2021 P137423, April, 2021 P137499, April, 2021 | 31,536 (130-count bottles) |
What to do — step by step
Stop Using Now
Immediately stop using the recalled Ranitidine tablets and dispose of them safely.
Questions people ask
Is this product safe to use?
No, the product contains a potential carcinogen (NDMA) that may pose health risks, so it should not be used.
How can I check if I have the recalled product?
Check for the product name 'Ranitidine 150 mg tablets, 24 count' with NDC code 37808-196-01, which were sold from August 2020 to April 2021.
What should I do if I have the recalled product?
Immediately stop using the product and dispose of it safely.
Contact AAA Pharmaceutical
We’ve drafted a message you can send AAA Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0645-2020 — AAA Pharmaceutical AAA Pharmaceutical Hello, I own a AAA Pharmaceutical that is covered by recall D-0645-2020 from AAA Pharmaceutical. 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-0645-2020 (December 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0645-2020 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.