Cephalexin For Suspension
FDA Recall NDC 67877-545
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 7 recorded enforcement report(s) associated with Cephalexin (NDC 67877-545). A significant event, classified as Class II, was initiated on May 23, 2025 by Ascend Laboratories, Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
May 2025 Class II Recall: Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
May 23, 2025
Jun 18, 2025
48,936 - 100 mL bottles
Recall Profile & Regulatory Data
Event ID
96912
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88
Batch or Lot Expiration Information
Lot# : 23141828, 23141829, Exp Date: 5/31/2025; 23142342, Exp Date: 6/30/2025; 23142708, Exp Date: 7/31/2025; 23144035, Exp Date: 10/31/2025; 23144270, Exp Date: 11/302025; 24140026, Exp Date: 12/31/2025
Affected Packages Involved in this Recall
67877-544-88Product
67877-544-68Product
67877-545-88Product
67877-545-68Product
May 2025 Class II Recall: Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
Recall Number
Class II Ongoing
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
May 23, 2025
Jun 18, 2025
10,620 - 200 mL bottles
Recall Profile & Regulatory Data
Event ID
96912
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
Batch or Lot Expiration Information
Lot# : 23142343, Exp Date: 6/30/2025; 23143526, Exp Date: 9/30/2025; 23144036, Exp Date: 10/31/2025; 23144269, Exp Date: 11/30/2025; Lot 24140027, Exp Date: 12/31/2025; 24144282, Exp Date: 10/31/2026
Affected Packages Involved in this Recall
67877-544-88Product
67877-544-68Product
67877-545-88Product
67877-545-68Product
Class II Terminated
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Jan 22, 2021
Feb 24, 2021
23,436 200 mL bottles
Recall Profile & Regulatory Data
Event ID
87214
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 02, 2022
Product Description
Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68
Batch or Lot Expiration Information
Lot# : 19141869, 19141870, EXP 3/2021; 19142762, EXP 5/2021; 19143826, 19143923,19143941, 19143954 EXP 7/2021
Affected Packages Involved in this Recall
67877-544-88Product
67877-544-68Product
67877-545-88Product
67877-545-68Product
Class II Terminated
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Jan 22, 2021
Feb 24, 2021
14,205 100 mL bottles
Recall Profile & Regulatory Data
Event ID
87214
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 02, 2022
Product Description
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88
Batch or Lot Expiration Information
Lot# 19144841, Exp 9/2021; 20141673 Exp 4/2022.
Affected Packages Involved in this Recall
67877-544-88Product
67877-544-68Product
67877-545-88Product
67877-545-68Product
Class II Terminated
Failed Impurity/Degradation Specifications
Dec 17, 2020
Jan 06, 2021
9,524 bottles
Recall Profile & Regulatory Data
Event ID
87032
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 03, 2023
Product Description
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68
Batch or Lot Expiration Information
Lot# 20141680, 20141681, 20141759
Affected Packages Involved in this Recall
67877-544-88Product
67877-544-68Product
67877-545-88Product
67877-545-68Product
Class II Terminated
Failed Impurity/Degradation Specifications
Dec 17, 2020
Jan 06, 2021
29,317 bottles
Recall Profile & Regulatory Data
Event ID
87032
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 03, 2023
Product Description
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88
Batch or Lot Expiration Information
Lot# 20141674, 20141675, 20141676, 20141677, 20141678
Affected Packages Involved in this Recall
67877-544-88Product
67877-544-68Product
67877-545-88Product
67877-545-68Product
Class II Terminated
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
Nov 23, 2020
Jan 13, 2021
20,232 bottles
Recall Profile & Regulatory Data
Event ID
86850
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Jun 01, 2023
Product Description
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054
Batch or Lot Expiration Information
Lot# : a) 19144340, 19144341, Exp AUG 2021; b) 20142226, 20142227, Exp MAY 2022
Affected Packages Involved in this Recall
67877-544-88Product
67877-544-68Product
67877-545-88Product
67877-545-68Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
