CLASS II Drug recall · Reported 3 Oct 2012 · FDA Enforcement Report
Naproxen Tablets recalled by Glenmark Generics Inc., U
Glenmark Generics Inc., U is recalling Naproxen Tablets USP per, distributed nationwide in the US. The recall was initiated on 6 Jul 2012 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-1701-2012
- FDA event ID
- 63264
- Recalling firm
- Glenmark Generics Inc., U, Mahwah, NJ
- Brand
- Naproxen Sodium
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jul 2012
- FDA classified
- 27 Sep 2012
- Reported
- 3 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 6 Jul 2012 | Recall initiated by company | |
| 27 Sep 2012 | Classified by FDA | +83 days |
| 3 Oct 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.
Where it was distributed
Nationwide
Questions about this recall
Is Naproxen Tablets USP per recalled?
Yes. Glenmark Generics Inc., U recalled Naproxen Tablets USP per on 6 Jul 2012. The recall is Class II and its status is Terminated. Recall number D-1701-2012.
Why was it recalled?
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
Which lots are affected?
Lot #: 02112930, 02112934, 02112941, Exp 09/14; 2112985, 02112986, 02113334, Exp 10/14; 02113360, 02113372, 02113420, 02113606, 02113663, 02113664, Exp 11/14.
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 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 Generics Inc., U
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine Tablets USP, 150 mg recalled by Glenmark Generics Inc., U | Glenmark Generics Inc., U | Foreign Material | Nationwide |
| Drug | CLASS III | Glenmark Topiramate Tablets, 200 mg recalledTopiramate | Glenmark Generics Inc., U | Other | Nationwide |
| Drug | CLASS III | Glenmark Pravastatin Sodium Tablets ,40 mg bottle recalledPravastatin Sodium | Glenmark Generics Inc., U | Other | Nationwide |
| Drug | CLASS III | Glenmark Gabapentin Tablets, a) 600mg bottle recalledGabapentin | Glenmark Generics Inc., U | Other | Nationwide |
| Drug | CLASS III | Montelukast Sodium Tablets, 10 mg (base) recalled | Glenmark Generics Inc., U | Packaging Defects | Nationwide |
Other Naproxen recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naproxen Oral Suspension, USP, 125 mg recalled by Acella PharmaceuticalsNaproxen | Acella Pharmaceuticals | Lead & Heavy Metals | Nationwide |
| Drug | CLASS II | Naproxen Sodium Tablets, USP, 550mg recalled by Glenmark PharmaceuticalsNaproxen Sodium | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Naproxen Tablets, USP 250mg recalled by Glenmark PharmaceuticalsNaproxen Sodium | Glenmark Pharmaceuticals Inc., U | Packaging Defects | Nationwide |
| Drug | CLASS II | Naproxen Sodium Tablets, USP 275 mg recalled by Glenmark PharmaceuticalsNaproxen Sodium | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Naproxen Sodium Tablets, USP 550 mg recalled by Glenmark PharmaceuticalsNaproxen Sodium | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |