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Food & drug recall · FDANovember 7, 2023Serious

Glenmark Pharmaceuticals Inc., USA — Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Glenmark Pharmaceuticals Inc., USA

The product

Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.

Details

Recall date
November 7, 2023
Brand
Glenmark Pharmaceuticals Inc., USA
Model, lot or SKU numbers
Lot# 19231903Exp 4/2025 Lot# 19231858Exp 4/2025 Lot# 19231881Exp 4/2025 Lot# 19233484: Exp 8/2025 Lot# 19233490Exp 8/2025
Where it was distributed

Nationwide

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: “Glenmark Pharmaceuticals Inc., USA — Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 0”

Read it on FDA →

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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