AuroMedics Pharma LLC recalls Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo
AuroMedics Pharma LLC recalls Ranitidine Syrup (15 mg/mL) due to detected N-nitrosodimethylamine (NDMA) contamination. This chemical is a potential carcinogen. Consumers with this product should contact the manufacturer for guidance.
Recall notice
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Contact the company & request your remedy
What happened, in plain English
AuroMedics Pharma LLC is recalling Ranitidine Syrup (15 mg/mL) because it contains N-nitrosodimethylamine (NDMA), a potential carcinogen. This recall is for prescription-only products sold in the U.S. The presence of NDMA in the syrup poses a health risk, especially with long-term use. Read more at govinfonow.com/recall/37761-auromedics-ranitidine-syrup-recall-ndma-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37761-auromedics-ranitidine-syrup-recall-ndma-contamination-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0529-2020
Cite this page
“AuroMedics Ranitidine Syrup Recall: NDMA Contamination Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37761-auromedics-ranitidine-syrup-recall-ndma-contamination-risk. Based on FDA recall #D-0529-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0529-2020%22&limit=1).
Why it’s dangerous
N-nitrosodimethylamine (NDMA) is a chemical that can form in some medications and is classified as a potential carcinogen. The presence of NDMA in Ranitidine Syrup may increase cancer risk with prolonged use, though the exact risk level is not specified in the recall.
Who’s affected
Prescription users of Ranitidine Syrup (15 mg/mL) in the U.S. who have the specific 474 mL bottle. Those with long-term use of the product are at higher risk due to potential carcinogen exposure.
How to tell if you have this one
Check for the 474 mL bottle labeled 'Ranitidine Oral Solution, USP' with 15 mg/mL concentration. The product is prescription-only and distributed by Aurobindo Pharma USA Inc. in the U.S.
- Brand
AuroMedics- Category
Drug
All 5 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
Ongoing- Distribution
nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0526-2020 | DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79; Lot # NBSB19001DA3; Exp FEB 2021 | 69,696 bottles |
| D-0527-2020 | Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60; RA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021 | 45,456 bottles |
| D-0528-2020 | Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30; RA3018001-A Jul 2020 RA3018002-A Jul-2020 RA3018003-A Jul 2020 RA3018004-A Aug 2020 RA3018005-A Aug 2020 RA3018006-A Aug 2020 RA3018007-A Sep 2020 RA3018008-A Sep 2020 RA3018009-A Sep 2020 RA3018010-A Oct 2020 RA3019001-A Jan 2021 RA3019002-A Jan 2021 RA3019003-A May 2021 | 134,160 bottles |
| D-0529-2020 | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74; UI1519001-A UI1519002-A UI1519003-A UI1519004-A | 19320 bottles |
| D-0530-2020 | Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05; RA1518002-B Jul 2020 RA1518003-A Jul 2020 RA1518004-A Aug 2020 RA1518005-A Aug 2020 RA1518007-A Sep 2020 RA1518008-A Sep 2020 RA1518009-A Sep 2020 RA1518010-A Oct 2020 RA1518011-A Nov 2020 RA1518012-A Nov 2020 RA1518013-A Nov 2020 RA1518014-A Nov 2020 RA1518015-A Nov 2020 RA1519003-B May 2021 RA1519004-A May 2021 | 26,736 bottles |
What to do — step by step
Contact Manufacturer
Reach out to AuroMedics Pharma LLC for specific instructions on handling the recalled product.
Questions people ask
Is this product safe to use?
The recall states that N-nitrosodimethylamine (NDMA) has been detected in the product, which is a potential carcinogen. The manufacturer has not confirmed if the product is safe for use.
How can I tell if I have the recalled product?
Look for the 474 mL bottle labeled 'Ranitidine Oral Solution, USP' with 15 mg/mL concentration. This product is prescription-only and distributed by Aurobindo Pharma USA Inc. in the U.S.
What should I do if I have the recalled product?
Contact AuroMedics Pharma LLC for specific instructions on handling the recalled product.
Contact AuroMedics
We’ve drafted a message you can send AuroMedics to request your refund or repair — edit it as you like.
Subject: Recall D-0529-2020 — AuroMedics AuroMedics Hello, I own a AuroMedics that is covered by recall D-0529-2020 from AuroMedics. 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-0529-2020 (November 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0529-2020 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.