CLASS II Drug recall · Reported 16 Oct 2019 · FDA Enforcement Report
Ranitidine Hydrochloride Capsules 150mg recalled by Sandoz
Sandoz is recalling Sandoz Ranitidine Hydrochloride Capsules 150mg, distributed nationwide in the US. The recall was initiated on 23 Sep 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-0127-2020
- FDA event ID
- 83875
- Recalling firm
- Sandoz, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Sep 2019
- FDA classified
- 7 Oct 2019
- Reported
- 16 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 23 Sep 2019 | Recall initiated by company | |
| 7 Oct 2019 | Classified by FDA | +14 days |
| 16 Oct 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: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
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
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Ranitidine Hydrochloride Capsules 150mg recalled?
Yes. Sandoz recalled Ranitidine Hydrochloride Capsules 150mg on 23 Sep 2019. The recall is Class II and its status is Terminated. Recall number D-0127-2020.
Why was it recalled?
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Which lots are affected?
HC9266 4/30/2020 HD1865 4/30/2020 HP9441 9/30/2020 JK7994 8/31/2021 JK8659 8/31/2021
Where was it sold?
U.S. 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.
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Other Sandoz ranitidine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine Hydrochloride Capsules 300mg recalled by Sandoz | Sandoz | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Hydrochloride Capsules 150mg recalled by Sandoz | Sandoz | Nitrosamine Impurity | Nationwide |