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Verified · FDAClass II — Possible RiskMedications

Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only Recall 2026

RANOLAZINEIssued September 17, 2026Updated Reviewed by the Recall Watch editorial team

RANOLAZINE Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02 — recalled per FDA on 9/17/2026. Reason: Failed Dissolution Specifications: below specification.

Agency
FDA
Issued
Sep 17, 2026
Brand
RANOLAZINE
Distribution
1 states
Lots affected
2
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued September 17, 2026 · Last synced Oct 14, 2026

What's recalled

Ranolazine Extended-Release Tablets, 1000 mg, 60-count bottle, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807. NDC: 27241-126-02

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Why it was recalled

Failed Dissolution Specifications: below specification

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot: DJ25134
Exp 11/30/2028
Where was it sold
1 state

Nationwide in the US.

nationwide
Official noticefda.gov
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the RANOLAZINE recall still active?

Yes, this recall is currently active as of September 17, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot: DJ25134, Exp 11/30/2028. Check the label on your product.

What should I do if I have the recalled RANOLAZINE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.