CLASS II Drug recall · Reported 16 Apr 2014 · FDA Enforcement Report
Ranitidine Tablets USP, 150 mg recalled by Glenmark Generics Inc., U
Glenmark Generics Inc. USA is recalling Ranitidine Tablets USP, 150 mg, distributed nationwide in the US. The recall was initiated on 18 Mar 2014 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-1229-2014
- FDA event ID
- 67776
- Recalling firm
- Glenmark Generics Inc. USA, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Mar 2014
- FDA classified
- 9 Apr 2014
- Reported
- 16 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 18 Mar 2014 | Recall initiated by company | |
| 9 Apr 2014 | Classified by FDA | +22 days |
| 16 Apr 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8, NDC 68462-248-05.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.
Which lots are affected?
Lot 12AN118A, Exp 10/14
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.
More recalls from Glenmark Generics Inc. USA
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|---|---|---|---|---|---|
| Drug | CLASS III | Glenmark Topiramate Tablets, 200 mg recalledTopiramate | Glenmark Generics Inc. USA | Other | Nationwide |
| Drug | CLASS III | Glenmark Pravastatin Sodium Tablets ,40 mg bottle recalledPravastatin Sodium | Glenmark Generics Inc. USA | Other | Nationwide |
| Drug | CLASS III | Glenmark Gabapentin Tablets, a) 600mg bottle recalledGabapentin | Glenmark Generics Inc. USA | Other | Nationwide |
| Drug | CLASS III | Montelukast Sodium Tablets, 10 mg (base) recalled | Glenmark Generics Inc. USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Naproxen Tablets recalled by Glenmark Generics Inc., UNaproxen Sodium | Glenmark Generics Inc. USA | Packaging Defects | Nationwide |
Other Ranitidine recalls
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine 150 mg, a) 60 Tabs recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | FL, GA |
| Drug | CLASS II | Ranitidine 300 mg, 30 Tabs recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | FL, GA |
| 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 hydrochloride, USP a) bottles recalled | PD-Rx Pharmaceuticals | Nitrosamine Impurity | 12 states |