CLASS II Drug recall · Reported 14 Oct 2020 · FDA Enforcement Report
Ranitidine 300 mg, 30 Tabs recalled by Direct Rx
Direct Rx is recalling Ranitidine 300 mg, 30 Tabs, distributed in Florida, Georgia. The recall was initiated on 15 Jan 2020 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-0017-2021
- FDA event ID
- 86498
- Recalling firm
- Direct Rx, Dawsonville, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jan 2020
- FDA classified
- 5 Oct 2020
- Reported
- 14 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 15 Jan 2020 | Recall initiated by company | |
| 5 Oct 2020 | Classified by FDA | +264 days |
| 14 Oct 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 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
Where it was distributed
FL, GA
Questions about this recall
Why was it recalled?
CGMP Deviations: Presence of NDMA impurity detected in product.
Which lots are affected?
Lot: 29JA1915 Exp. 09/30/2021
Where was it sold?
FL, GA
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
1 other product · FDA event 86498| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ranitidine 150 mg, a) 60 Tabs recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | FL, GA |
More recalls from Direct Rx
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Duloxetine D/R, a) 30 mg recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine D/R, 30 mg, 30 Caps recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophth Solution recalled by Direct Rx | Direct Rx | Packaging Defects | 5 states |
| Drug | CLASS II | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled | Direct Rx | Potency & Assay | 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 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 |
| Drug | CLASS II | Ranitidine Hydrochloride (powder) recalled | Spectrum Laboratory Products | Nitrosamine Impurity | 11 states |