Teva Montelukast Sodium Oral Granules 4mg Recall: Failed Impurities Risk

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Recalling firmTeva Pharmaceuticals USA Inc400 Interpace Pkwy Bldg A · Parsippany, NJ 07054-1120

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Teva is recalling Montelukast Sodium Oral Granules 4mg (30-pack) because impurities in the product could be harmful. This is a prescription-only medication that may pose health risks if used.

Why it’s dangerous

The product failed impurities testing for Sulphoxide and Impurity A. This could mean harmful substances are present, potentially causing health issues if taken.

Who’s affected

Prescription patients who have the specific lot number (3007556A) of Montelukast Sodium Oral Granules 4mg (30-pack) from Teva. Those with the medication are most at risk.

How to tell if you have this one

Check for the carton NDC 0093-7487-56 and packet NDC 0093-7487-19. Look for lot number 3007556A with expiration date 5/2023.

Brand
Teva
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the carton NDC 0093-7487-56, packet NDC 0093-7487-19, and lot number 3007556A.

✎ GovInfoNow

Questions people ask

Is this medication safe to use?

The recall states failed impurities testing, but the official notice does not specify if it's safe to use.

What should I do if I have this medication?

The recall does not provide a remedy, so the official notice does not specify actions to take.

How can I confirm if I have the recalled product?

Check the carton NDC 0093-7487-56, packet NDC 0093-7487-19, and lot number 3007556A with expiration 5/2023.

Take action

Contact Teva

We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0510-2023 — Teva Teva

Hello,

I own a Teva that is covered by recall D-0510-2023 from Teva.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0510-2023 (March 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0510-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Teva Pharmaceuticals USA Inc recalls Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva

Recall notice