Prescription Naproxen Sodium tablets recalled for manufacturing deviations
Glenmark Pharmaceuticals is recalling Naproxen Sodium 550mg tablets nationwide due to manufacturing process deviations. The recall is voluntary and firm-initiated.
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: FDA Class II classification with no reported illnesses or injuries. Voluntary firm-initiated recall for manufacturing process deviations, fitting the rubric criterion for 'voluntary precautionary recalls' at Moderate severity.
Plain-English summary
Glenmark Pharmaceuticals Inc. USA is recalling Naproxen Sodium Tablets, USP, 550mg in 100-count bottles (NDC #68462-179-01 and related codes) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The affected lot is #17231956 with an expiration date of August 2025.
The firm initiated the recall on March 13, 2025, and voluntarily reported it to the FDA, which classified the recall as Class II. The recall is ongoing.
The specific nature of the manufacturing deviation has not been publicly detailed. Consumers with questions about whether their medication is affected should contact their pharmacy or healthcare provider.
The recalled product
- Product
- NAPROXEN SODIUM (NAPROXEN SODIUM)
- Brand
- NAPROXEN SODIUM
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Hazard
- quality-defect
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 550 mg Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2021-09-29
- ModerateGlenmark Naproxen Sodium Tablets recalled for CGMP deviations
FDA (Drugs) · 2021-09-29
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