CLASS II Drug recall · Reported 20 Nov 2019 · FDA Enforcement Report
Equate Maximum Strength Ranitidine Tablets recalled by Apotex
Apotex is recalling Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets, 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-0318-2020
- 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 Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716
Where it was distributed
Nationwide
Stores named: Walmart
Questions about this recall
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 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
5 other products · FDA event 83871This product is part of a recall event; the main page for the event is Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer recalled | Apotex | Nitrosamine Impurity | Nationwide | |
| CLASS II | Rite Aid Pharmacy Maximum Strength Ranitidine Tablets recalled by Apotex | Apotex | Nitrosamine Impurity | Nationwide | |
| CLASS II | Rite Aid Pharmacy Maximum Strength Ranitidine Tablets recalled by Apotex | Apotex | Nitrosamine Impurity | Nationwide | |
| CLASS II | Walgreens Regular Strength Wal-Zan, USP 75 mg/Acid Reducer recalled | Apotex | Nitrosamine Impurity | Nationwide | |
| CLASS II | Walgreens Maximum Strength Wal-Zan, USP 150 mg/Acid Reducer recalled | Apotex | Nitrosamine Impurity | Nationwide |
More recalls from Apotex
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
Other Equate Maximum Strength Ranitidine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer recalled | Apotex | Nitrosamine Impurity | Nationwide |