Naproxen Sodium tablets recalled due to manufacturing compliance deviations
Glenmark Pharmaceuticals Inc., USA is recalling Naproxen Sodium Tablets, USP 550mg nationwide due to CGMP (Current Good Manufacturing Practice) deviations identified during manufacturing. The recall affects lot #17231956 with expiration date Aug-25.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for CGMP deviations (manufacturing compliance issues) with no reported illnesses or injuries. Manufacturing deviations without evidence of product harm or contamination are classified as Moderate per the rubric.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is voluntarily recalling Naproxen Sodium Tablets, USP, 550mg, 100-count bottles (NDC# 68462-179-01 and related package NDCs) distributed nationwide. The recall was initiated on March 13, 2025, due to CGMP (Current Good Manufacturing Practice) deviations discovered at the manufacturing facility.
The affected product is lot #17231956 with an expiration date of August 2025. The product is a prescription medication manufactured by Glenmark Pharmaceuticals Limited in Pithampur, Madhya Pradesh, India, and manufactured for Glenmark Pharmaceuticals Inc. USA in Mahwah, NJ.
Consumers who have dispensed prescriptions of this product should consult with their healthcare provider or pharmacist before discontinuing use. Healthcare providers and pharmacists should quarantine affected bottles and return them to the supplier. Patients with questions should contact Glenmark Pharmaceuticals Inc., USA.
The recalled product
- Product
- NAPROXEN SODIUM (NAPROXEN SODIUM)
- Brand
- NAPROXEN SODIUM
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Prescription / NSAID
- Hazard
- cgmp-deviation
- manufacturing-compliance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 17231956
- exp. date Aug-25
UPCs (5)
- 0368462189016
- 0368462178010
- 0368462179017
- 0368462188019
- 0368462190012
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · NAPROXEN SODIUM
- HighPrescription Naproxen 250mg tablets recalled for labeling mix-up with indomethacin
FDA (Drugs) · 2023-12-06
- ModerateGlenmark Naproxen Sodium Tablets recalled for CGMP deviations
FDA (Drugs) · 2021-09-29
- ModerateGlenmark Naproxen Sodium 550 mg Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2021-09-29
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