CLASS II ONGOING Drug recall · Reported 15 Jan 2020 · FDA Enforcement Report
Glenmark Ranitidine Tablets USP 150 mg recalled
Glenmark Pharmaceuticals Inc., U is recalling Glenmark Ranitidine Tablets USP 150 mg. The recall was initiated on 17 Dec 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-0640-2020
- FDA event ID
- 84516
- Recalling firm
- Glenmark Pharmaceuticals Inc., U, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Dec 2019
- FDA classified
- 5 Jan 2020
- Reported
- 15 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 17 Dec 2019 | Recall initiated by company | |
| 5 Jan 2020 | Classified by FDA | +19 days |
| 15 Jan 2020 | Published in enforcement report | +10 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
Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01
Where it was distributed
Natiowide
Questions about this recall
Is Glenmark Ranitidine Tablets USP 150 mg recalled?
Yes. Glenmark Pharmaceuticals Inc., U recalled Glenmark Ranitidine Tablets USP 150 mg on 17 Dec 2019. The recall is Class II and its status is Ongoing. Recall number D-0640-2020.
Why was it recalled?
CGMP Deviations: Presence of NDMA impurity detected in product.
Which lots are affected?
7701033A 7701826A 7702344A 7702345A 7702489A 7702706A 7702707A 7702708A 7702858A 7702859A 7702860A 7702928A 7702929A 7703196A 7703634A 7704492A 7704493A 7705159A 19190289 19190342 19190372
Where was it sold?
Natiowide
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 Glenmark Pharmaceuticals Inc., U
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|---|---|---|---|---|---|
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| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., U | Packaging Defects | Nationwide |