CLASS II ONGOING Drug recall · Reported 18 Dec 2019 · FDA Enforcement Report
Ranitidine Syrup Oral Solution 15 mg/mL fl. oz recalled
Amneal Pharmaceuticals is recalling Ranitidine Syrup Oral Solution 15 mg/mL fl. oz, distributed nationwide in the US. The recall was initiated on 22 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-0614-2020
- FDA event ID
- 84353
- Recalling firm
- Amneal Pharmaceuticals, Brookhaven, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Nov 2019
- FDA classified
- 9 Dec 2019
- Reported
- 18 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 22 Nov 2019 | Recall initiated by company | |
| 9 Dec 2019 | Classified by FDA | +17 days |
| 18 Dec 2019 | Published in enforcement report | +9 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: Impurity N-nitrosodimethylamine (NDMA) found in API
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 Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Where it was distributed
Product was distributed throughout the United States.
Questions about this recall
Why was it recalled?
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Which lots are affected?
06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
Where was it sold?
Product was distributed throughout the United States.
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 84353This product is part of a recall event; the main page for the event is Ranitidine Tablets, USP 300 mg - a) recalled by Amneal Pharmaceuticals.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ranitidine Tablets, USP 300 mg - a) recalled by Amneal Pharmaceuticals | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide | |
| CLASS II | Ranitidine Tablets, USP 300 mg recalled by Amneal PharmaceuticalsRanitidine | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide | |
| CLASS II | Ranitidine Tablets, USP 150 mg a) recalled by Amneal Pharmaceuticals | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide | |
| CLASS II | Ranitidine Tablets, USP 150 mg recalled by Amneal PharmaceuticalsRanitidine | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide |
More recalls from Amneal Pharmaceuticals
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol Gel, 0.1%, 0.25 mg, 30-packets recalledEstradiol | Amneal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg recalled by Amneal PharmaceuticalsPrimidone | Amneal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS I | Magnesium Sulfate in Water for Injection (40mg/mL) IV recalledMagnesium Sulfate | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP, 50 mg recalled | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
Other Ranitidine recalls
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine 150 mg, a) 60 Tabs recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | FL, GA |
| Drug | CLASS II | Ranitidine 300 mg, 30 Tabs recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | FL, GA |
| Drug | CLASS II | Ranitidine Tablets, USP, 150 mg x 10 blister card) recalled | American Health Packaging | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Oral Solution, USP, 150 mg/, [ x Dose Cups recalled | Precision Dose | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | ranitidine hydrochloride, USP a) bottles recalled | PD-Rx Pharmaceuticals | Nitrosamine Impurity | 12 states |