CLASS II Drug recall · Reported 13 Nov 2019 · FDA Enforcement Report
Ranitidine Tablets, USP 150 mg, a.) bottles recalled
Dr. Reddy's Laboratories is recalling Ranitidine Tablets, USP 150 mg, a.) bottles (, distributed nationwide in the US. The recall was initiated on 1 Oct 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-0184-2020
- FDA event ID
- 83908
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 1 Oct 2019
- FDA classified
- 5 Nov 2019
- Reported
- 13 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 1 Oct 2019 | Recall initiated by company | |
| 5 Nov 2019 | Classified by FDA | +35 days |
| 13 Nov 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: 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 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC
Where it was distributed
Product was distributed to major distributors throughout the United States who may have further distributed the product.
Questions about this recall
Is Ranitidine Tablets, USP 150 mg, a.) bottles ( recalled?
Yes. Dr. Reddy's Laboratories recalled Ranitidine Tablets, USP 150 mg, a.) bottles ( on 1 Oct 2019. The recall is Class II and its status is Completed. Recall number D-0184-2020.
Why was it recalled?
CGMP Deviations: Presence of NDMA impurity detected in product.
Which lots are affected?
Batch Numbers: All lots within expiry.
Where was it sold?
Product was distributed to major distributors throughout the United States who may have further distributed the product.
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 Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | 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 300 mg a) recalled by Denton Pharma | Denton Pharma | 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 |