CLASS II Drug recall · Reported 20 Nov 2019 · FDA Enforcement Report
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer recalled
Apotex is recalling Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer, distributed nationwide in the US. The recall was initiated on 24 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-0316-2020
- FDA event ID
- 83871
- Recalling firm
- Apotex, North York, N/A
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 24 Sep 2019
- FDA classified
- 12 Nov 2019
- Reported
- 20 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 24 Sep 2019 | Recall initiated by company | |
| 12 Nov 2019 | Classified by FDA | +49 days |
| 20 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
GGMP Deviations: Possible contamination with 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
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00
Where it was distributed
Nationwide
Stores named: Walmart
Questions about this recall
Is Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer recalled?
Yes. Apotex recalled Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer on 24 Sep 2019. The recall is Class II and its status is Completed. Recall number D-0316-2020.
Why was it recalled?
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Which lots are affected?
All lots remaining within expiry.
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.
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Other Equate maximum strength ranitidine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Equate Maximum Strength Ranitidine Tablets recalled by Apotex | Apotex | Nitrosamine Impurity | Nationwide |