Cephalexin Capsule
FDA Recall NDC 0093-3147
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Cephalexin (NDC 0093-3147). A significant event, classified as Class II, was initiated on Aug 24, 2020 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
August 2020 Class II Recall: CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Recall Number
Class II Terminated
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Aug 24, 2020
Sep 16, 2020
103,940 bottles
Recall Profile & Regulatory Data
Event ID
86285
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S. and Puerto Rico.
Termination Date
Dec 16, 2021
Product Description
Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Batch or Lot Expiration Information
Lot# s: a) 30309820A, Exp. 08/2020; 30310000B, 30310001B, Exp. 10/2020; 30310096A Exp. 01/2021; 30310228A, Exp. 03/2021; 30310313A, Exp. 06/2021; b) 30309861A, Exp. 08/2020; 30310335A, Exp. 06/2021.
Affected Packages Involved in this Recall
0093-3145-01Product
0093-3145-05Product
0093-3147-01Product
0093-3147-05Product
0093-4175-73Product
0093-4175-74Product
0093-4177-73Product
0093-4177-74Product
Class II Terminated
Sub-Potent Drug: Out of specification test results for potency (below specification).
Aug 24, 2020
Sep 16, 2020
38,487 bottles
Recall Profile & Regulatory Data
Event ID
86285
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S. and Puerto Rico.
Termination Date
Dec 16, 2021
Product Description
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.
Batch or Lot Expiration Information
Lot# : 30310638A, Exp. 02/2022
Affected Packages Involved in this Recall
0093-3145-01Product
0093-3145-05Product
0093-3147-01Product
0093-3147-05Product
0093-4175-73Product
0093-4175-74Product
0093-4177-73Product
0093-4177-74Product
August 2020 Class II Recall: CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Recall Number
Class II Terminated
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Aug 24, 2020
Sep 16, 2020
1,467,535 bottles
Recall Profile & Regulatory Data
Event ID
86285
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S. and Puerto Rico.
Termination Date
Dec 16, 2021
Product Description
Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Batch or Lot Expiration Information
Lot# s: a) 30309862A, 30309863A, Exp. 08/2020; 30309928A, 30309929A, Exp. 09/2020; 30310029A, 30310030A, 30310033A, 30310034A, Exp. 10/2020; 30310035A, 30310079A, 30310080A, 30310081A, Exp. 11/2020; 30310134A, 30310135A, Exp. 01/2021; 30310182A, 30310183A, 30310210A, Exp. 02/2021; 30310211A, 30310246A, Exp. 03/2021; 30310282A, Exp. 04/2021; 30310290A, Exp. 05/2021; 30310394A, 30310395A, Exp.07/2021; 30310457A, Exp. 09/2021; 30310506A, 30310507A, Exp. 10/2021; 30310555A, 30310605A, Exp. 11/2021. b) 30309864A, 30309865A, Exp. 08/2020; 30309930A, 30309931A, Exp. 09/2020; 30309991A, 30309992A, 30310028A, Exp.10/2020; 30310036A, 30310037A, 30310038A, Exp. 11/2020; 30310082A, 30310083A, Exp. 12/2020; 30310136A, 30310137A, Exp. 01/2021; 30310184A, 30310185A, Exp. 02/2021; 30310212A, Exp. 03/2021; 30310303A, Exp. 04/2021; 30310327A, Exp. 06/2021; 30310396A, 30310407A, Exp. 08/2021; 30310445A, Exp. 09/2021; 30310556A, Exp. 10/2021.
Affected Packages Involved in this Recall
0093-3145-01Product
0093-3145-05Product
0093-3147-01Product
0093-3147-05Product
0093-4175-73Product
0093-4175-74Product
0093-4177-73Product
0093-4177-74Product
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.
