The Recall Registry
Recall data checked 13 hours ago

Home › Prescription medicine › Granules Pharmaceuticals Inc. — Metoprolol…

Food & drug recall · FDAJune 24, 2025Serious

Granules Pharmaceuticals Inc. — Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only

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

What’s wrong

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

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: Granules Pharmaceuticals Inc.

The product

Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,

Details

Units affected
27,648 100-count Bottles; 5,376 500-count Bottles
Recall date
June 24, 2025
Brand
Granules Pharmaceuticals Inc.
Model, lot or SKU numbers
Lot # a)1400008A, Exp Date: 12/31/2025b) 1400008B, Exp Date: 12/31/2025
Where it was distributed

Nationwide in the USA

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: “Granules Pharmaceuticals Inc. — Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab”

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

Other prescription medicine recalls