FDA Recall D-0510-2025

Granules Pharmaceuticals Inc. · Chantilly, VA

Class II Ongoing 324 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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,

Lot / code: Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025

Quantity: 27,648 100-count Bottles; 5,376 500-count Bottles

Reason for recall

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

Recall record

Recall number: D-0510-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA.
Recall initiated: 2025-06-24
Classified by FDA Center: 2025-07-08
FDA published: 2025-07-09
Recalling firm: Granules Pharmaceuticals Inc.
Firm location: Chantilly, VA

Drug identification

Brand name(s): METOPROLOL SUCCINATE
Generic name(s): METOPROLOL SUCCINATE
Manufacturer(s): Granules Pharmaceuticals Inc.
NDC(s): 70010-780, 70010-781, 70010-782, 70010-783
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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