Class II · Moderate risk Ongoing
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories…
Reason Failed Dissolution Specifications
Is Metoprolol recalled?
43 FDA recalls mention Metoprolol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Metoprolol.
Class II · Moderate risk Ongoing
Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal…
Reason CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class II · Moderate risk Ongoing
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal…
Reason CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Class II · Moderate risk Ongoing
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count…
Reason Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH)…
Class II · Moderate risk Ongoing
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured…
Reason Presence of Foreign Substance: metal in tablet
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count…
Reason Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were…
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories…
Reason Failed Dissolution Specification
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories…
Reason Failed Dissolution Specification
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories…
Reason Failed Dissolution Specification
Class II · Moderate risk Terminated
Metoprolol tablets 50 mg, 100-count botte, Rx only, MFG: Sun Pharmaceuticals, NDC 57664-0477-52
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA…
Reason CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories…
Reason Failed Dissolution Specifications.
Class II · Moderate risk Terminated
Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609…
Reason Complaint received of foreign matter (metal) embedded in tablet.
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279…
Reason Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Class II · Moderate risk Terminated
Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk Terminated
Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC#…
Reason Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Class II · Moderate risk Terminated
Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL…
Reason Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Class III · Low risk Terminated
Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for…
Reason Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's…
Reason Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante…
Class II · Moderate risk Terminated
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500…
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
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