CLASS II ONGOING Drug recall · Reported 4 Dec 2019 · FDA Enforcement Report
Aurobindo Ranitidine Caspules 150 mg recalled by AuroMedics Pharma
AuroMedics Pharma is recalling Aurobindo Ranitidine Caspules 150 mg, distributed nationwide in the US. The recall was initiated on 6 Nov 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0527-2020
- FDA event ID
- 84218
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Nov 2019
- FDA classified
- 26 Nov 2019
- Reported
- 4 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 6 Nov 2019 | Recall initiated by company | |
| 26 Nov 2019 | Classified by FDA | +20 days |
| 4 Dec 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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
Where it was distributed
nationwide
Questions about this recall
Is Aurobindo Ranitidine Caspules 150 mg recalled?
Yes. AuroMedics Pharma recalled Aurobindo Ranitidine Caspules 150 mg on 6 Nov 2019. The recall is Class II and its status is Ongoing. Recall number D-0527-2020.
Why was it recalled?
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Which lots are affected?
RA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021
Where was it sold?
nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AuroMedics Pharma
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fondaparinux Sodium Injection, USP, 5 mg per, Single Dose recalledFondaparinux Sodium | AuroMedics Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalledAcyclovir Sodium | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Polymyxin B for Injection USP per Vial vials recalledPolymyxin B | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1,000 mg recalled by AuroMedics PharmaAcetaminophen | AuroMedics Pharma | Other | Nationwide |