CLASS II Drug recall · Reported 29 Jan 2020 · FDA Enforcement Report
Ranitidine Tablets, USP 300 mg a) recalled by Denton Pharma
Denton Pharma is recalling Ranitidine Tablets, USP 300 mg a), distributed nationwide in the US. The recall was initiated on 20 Dec 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-0795-2020
- FDA event ID
- 84657
- Recalling firm
- Denton Pharma, North Blenheim, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Dec 2019
- FDA classified
- 20 Jan 2020
- Reported
- 29 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 20 Dec 2019 | Recall initiated by company | |
| 20 Jan 2020 | Classified by FDA | +31 days |
| 29 Jan 2020 | 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: Presence of NDMA impurity detected in product.
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 Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
Where it was distributed
Nationwide
Questions about this recall
Is Ranitidine Tablets, USP 300 mg a) recalled?
Yes. Denton Pharma recalled Ranitidine Tablets, USP 300 mg a) on 20 Dec 2019. The recall is Class II and its status is Terminated. Recall number D-0795-2020.
Why was it recalled?
CGMP Deviations: Presence of NDMA impurity detected in product.
Which lots are affected?
a). N106851901, Exp. 11/30/2021 N106851902, Exp. 10/31/2021 b). C106851901, Exp. 11/30/2021 C106851902 Exp. 10/31/2021 C106851903 Exp. 02/28/2022 C106851904 Exp. 11/30/2021 C106851905 Exp. 05/31/2022
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 Denton Pharma
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets USP 750 mg recalled | Denton Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) recalled | Denton Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Tablets, USP 150 mg , a) recalled by Denton Pharma | Denton Pharma | Nitrosamine Impurity | Nationwide |
Other Ranitidine recalls
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 Tablets, USP 150 mg , a) recalled by Denton Pharma | Denton Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Capsules 150 mg, (a) bottles recalled by Appco Pharma | Appco Pharma | Nitrosamine Impurity | NJ |
| Drug | CLASS II | Ranitidine Capsules 300 mg recalled by Appco Pharma | Appco Pharma | Nitrosamine Impurity | NJ |