CLASS II ONGOING Drug recall · Reported 4 Dec 2019 · FDA Enforcement Report
Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg recalled
AuroMedics Pharma is recalling Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 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-0529-2020
- 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
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
Where it was distributed
nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Which lots are affected?
UI1519001-A UI1519002-A UI1519003-A UI1519004-A
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 84218| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Aurobindo Ranitidine Capsules 300 mg recalled by AuroMedics Pharma | AuroMedics Pharma | Nitrosamine Impurity | Nationwide | |
| CLASS II | Aurobindo Ranitidine Caspules 150 mg recalled by AuroMedics Pharma | AuroMedics Pharma | Nitrosamine Impurity | Nationwide | |
| CLASS II | Aurobindo Ranitidine Capsules 150 mg recalled by AuroMedics Pharma | AuroMedics Pharma | Nitrosamine Impurity | Nationwide | |
| CLASS II | DG Health Acid Reducer Ranitidine Tablets 150 mg recalled | AuroMedics Pharma | Nitrosamine Impurity | Nationwide |
More recalls from AuroMedics Pharma
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fondaparinux Sodium Injection, USP, 7.5 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 |
Other Ranitidine (ranitidine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL recalled | American Health Packaging | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL recalled | Lannett | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg recalled | Bio-pharm | Potency & Assay | Nationwide |
| Drug | CLASS III | Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL (75 mg recalled | Vintage Pharmaceuticals LLC | Potency & Assay | Nationwide |
| Drug | CLASS II | Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL recalled | Actavis South Atlantic | Potency & Assay | Nationwide |