Class IIAscend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.2026-05-20
Failed Dissolution Specifications
Recalling firm: Ascend Laboratories, LLC
Class IIMetoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 070542026-03-11
Failed Dissolution Specifications
Recalling firm: Teva Pharmaceuticals USA, Inc
Class IIMetoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 070542026-03-11
Failed Dissolution Specifications
Recalling firm: Teva Pharmaceuticals USA, Inc
Class IIMetoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-112026-03-11
Failed Dissolution Specifications
Recalling firm: Teva Pharmaceuticals USA, Inc
Class IIMetoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.2026-03-11
Failed Dissolution Specifications
Recalling firm: Teva Pharmaceuticals USA, Inc
Class IIMetoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-102025-08-20
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Recalling firm: Westminster Pharmaceuticals LLC
Class IIMetoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-102025-08-20
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Recalling firm: Westminster Pharmaceuticals LLC
Class IIMetoprolol 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 20151,2025-07-09
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Recalling firm: Granules Pharmaceuticals Inc.
Class IIMetoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-002024-06-05
Presence of Foreign Substance: metal in tablet
Recalling firm: Rubicon Research Private Limited
Class IIMetoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-962024-01-03
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling firm: CARDINAL HEALTHCARE
Class IIMetoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories2023-02-22
Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
Recalling firm: Amerisource Health Services LLC
Class IIMetoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01.2023-02-01
Failed Dissolution Specification
Recalling firm: Ascend Laboratories, LLC
Class IIMetoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-01.2023-02-01
Failed Dissolution Specification
Recalling firm: Ascend Laboratories, LLC
Class IIMetoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05.2023-02-01
Failed Dissolution Specification
Recalling firm: Ascend Laboratories, LLC
Class IIMetoprolol tablets 50 mg, 100-count botte, Rx only, MFG: Sun Pharmaceuticals, NDC 57664-0477-522022-06-15
cGMP deviations: Temperature abuse
Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Class IIMetoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-032022-02-02
Failed Dissolution Specifications
Recalling firm: American Health Packaging
Class IIMetoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, 07054, NDC 67877-590-01.2022-02-02
Failed Dissolution Specifications.
Recalling firm: Ascend Laboratories, LLC
Class IIMetoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-002022-01-19
Complaint received of foreign matter (metal) embedded in tablet.
Recalling firm: Rubicon Research Private Limited
Class IIMetoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-992021-09-29
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Recalling firm: Aurobindo Pharma USA Inc.
Class IIMetoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA2021-06-02
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm: Cardinal Health Inc.
Class IIIMetoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-002018-11-21
Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Recalling firm: RemedyRepack Inc.
Class IIIMetoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-102018-11-14
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Recalling firm: Baxter Healthcare Corporation
Class IIMetoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-012018-10-31
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Recalling firm: Teva Pharmaceuticals USA
Class IIMetoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle, Rx only, Manufactured by: Dr. Reddy's Laboratories Limited Bachupally-500 090 India\ NDC 55111-468-012018-05-16
Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
Recalling firm: Dr. Reddy's Laboratories, Inc.
Class IIMetoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0735-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.2015-07-29
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recalling firm: Wockhardt Usa Inc.
Class IIMetoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repacking Only (NDC: 64679-734-08) and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0734-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.2015-07-29
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recalling firm: Wockhardt Usa Inc.
Class IIMetoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA .2015-07-29
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recalling firm: Wockhardt Usa Inc.
Class IIMetoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC, 20 Waterview Blvd. Parsippany, NJ 07054 USA .2015-07-29
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recalling firm: Wockhardt Usa Inc.
Class IIIWockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .2014-12-24
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Recalling firm: Wockhardt Usa Inc.
Class IIMetoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.2014-10-15
Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol
Recalling firm: Mylan Pharmaceuticals Inc.
Class IIWockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA2014-08-27
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Recalling firm: Wockhardt Usa Inc.
Class IIDr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-012014-06-18
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Recalling firm: Dr. Reddy's Laboratories, Inc.
Class IIMetoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Water view Blvd., Parsippany, NJ 07054, USA. NDC: 64679-736-02.2014-06-04
Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
Recalling firm: Wockhardt Usa Inc.
Class IIMetoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.2014-05-14
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Recalling firm: Wockhardt Usa Inc.
Class IIDr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratories Limited Bachepalli -500 090 INDIA NDC 55111-467-012014-02-12
Failed Dissolution Specification; 12-Month stability interval.
Recalling firm: Dr. Reddy's Laboratories, Inc.
Class IIMETOPROLOL TARTRATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378001801.2014-01-29
Labeling: Label Mixup: METOPROLOL TARTRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: A
Recalling firm: Aidapak Services, LLC
Class IIMETOPROLOL TARTRATE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093073301.2014-01-29
Labeling: Label Mixup: METOPROLOL TARTRATE, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: METOPROLOL TARTRATE, Tablet, 25 mg, NDC 57664050652, P
Recalling firm: Aidapak Services, LLC
Class IIMETOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 633040579012014-01-22
Labeling:Label Mixup; METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD22845_1, EXP: 4
Recalling firm: Aidapak Services, LLC
Class IIMETOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 576640506522014-01-22
Labeling:Label Mixup; METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD68022_1, EX
Recalling firm: Aidapak Services, LLC
Class IIMETOPROLOL TARTRATE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 576640506522014-01-22
Labeling:Label Mixup; METOPROLOL TARTRATE, Tablet, 25 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003826, EXP: 6/27/2014; amLODIP
Recalling firm: Aidapak Services, LLC
Class IIMETOPROLOL SUCCINATE ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 620370833012014-01-22
Labeling:Label Mixup; METOPROLOL SUCCINATE ER, Tablet, 200 mg may be potentially mislabeled as Pedigree: AD73652_13, EXP: 5/30/2014.
Recalling firm: Aidapak Services, LLC
Class IIMetoprolol Injection, all strengths and all presentations including Metoprolol 1 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.2013-05-22
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated
Recalling firm: FVS Holdings, Inc. dba. Green Valley Drugs
Class IIMetoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-102012-07-11
Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
Recalling firm: Teva Pharmaceuticals USA, Inc.