CLASS II Drug recall · Reported 29 Sep 2021 · FDA Enforcement Report
Naproxen Sodium Tablets, USP 550 mg recalled by Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Inc., USA is recalling Naproxen Sodium Tablets, USP 550 mg, distributed nationwide in the US. The recall was initiated on 27 Aug 2021 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-0822-2021
- FDA event ID
- 88591
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Brand
- Naproxen Sodium
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Aug 2021
- FDA classified
- 21 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 27 Aug 2021 | Recall initiated by company | |
| 21 Sep 2021 | Classified by FDA | +25 days |
| 29 Sep 2021 | 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
CGMP Deviations
Product as listed by the FDA
Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lots: a) 29190082 Exp. 09/30/2021; 29190083 Exp. 09/30/2021; 29190084 Exp. 10/31/2021; 29190085 Exp. 10/31/2021; 29200001 Exp. 12/31/2021; 29200003 Exp. 01/31/2022; 29200004 Exp. 01/31/2022; 29200005 Exp. 01/31/2022; 29200012 Exp. 02/28/2022; 29200013 Exp. 02/28/2022; b) 29200010 Exp. 02/28/2022
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
7 other products · FDA event 88591This product is part of a recall event; the main page for the event is Fulvestrant Injection 250 mg recalled by Glenmark Pharmaceuticals.
More recalls from Glenmark Pharmaceuticals Inc., USA
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
Other Naproxen recalls
All 8| 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., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Naproxen Tablets, USP 250mg recalled by Glenmark PharmaceuticalsNaproxen Sodium | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Naproxen Sodium Tablets, USP 275 mg recalled by Glenmark PharmaceuticalsNaproxen Sodium | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Naproxen, Tablet, 500 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |