Prescription Naproxen 250mg tablets recalled for labeling mix-up with indomethacin
Glenmark Pharmaceuticals is recalling Naproxen Sodium 250mg tablets nationwide due to a labeling mix-up where Indomethacin bottles may be labeled as Naproxen. Patients could receive the wrong medication.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a labeling mix-up where Indomethacin is mislabeled as Naproxen Sodium. No illnesses or deaths reported, but medication substitution poses serious risk of adverse effects and therapeutic failure.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Naproxen Sodium Tablets, USP 250mg in 100-count bottles distributed nationwide. The recall is due to a labeling mix-up in which some bottles containing Indomethacin are labeled as Naproxen Sodium.
This is a serious medication error. While both Indomethacin and Naproxen Sodium are nonsteroidal anti-inflammatory drugs (NSAIDs), they have different uses and safety profiles. A patient expecting to take Naproxen who instead receives Indomethacin could experience adverse effects or fail to receive intended treatment.
The recall affects Naproxen Sodium 250mg tablets with NDC 68462-188-01 and the following lot numbers: 19231903, 19231858, 19231881, 19233484, and 19233490. Expiration dates range from April 2025 to August 2025.
Patients who have received Naproxen Sodium from the affected lots should contact their pharmacist or physician immediately. Do not use the product. Return it to the pharmacy where it was dispensed. Consult your healthcare provider if you have taken medication from an affected lot.
The recalled product
- Product
- NAPROXEN SODIUM (NAPROXEN SODIUM)
- Brand
- NAPROXEN SODIUM
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — NSAID / Pain Relief
- Hazard
- medication-mislabeling
- medication-substitution
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 (5)
- Lot# 19231903
- Exp 4/2025 Lot# 19231858
- Exp 4/2025 Lot# 19231881
- Exp 4/2025 Lot# 19233484: Exp 8/2025 Lot# 19233490
- Exp 8/2025
UPCs (5)
- 0368462189016
- 0368462178010
- 0368462179017
- 0368462188019
- 0368462190012
Distribution
Distributed nationwide across the United States.
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