Class II · ModerateActive recall
Ranitidine
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberHB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
Where it was soldProduct was distributed throughout the United States.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAmneal Pharmaceuticals of New York LLC
| Brand name | RANITIDINE |
| Generic name | RANITIDINE |
| Active ingredient(s) | RANITIDINE HYDROCHLORIDE |
| Distributed by / for | Amneal Pharmaceuticals, Inc. |
| NDC | 53746-254-02 |
Show the full FDA record
| Full product label | Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02. |
| Recalling firm | Amneal Pharmaceuticals, Inc. |
| Distribution | Product was distributed throughout the United States. |
| Quantity | N/A |
| Recall initiated | 2019-11-22 |
| Report date | 2019-12-18 |
| Recall completed | — |
| Recall number | D-0616-2020 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Brookhaven NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.