Cefdinir Powder, For Suspension
FDA Recall NDC 68180-722
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 10 recorded enforcement report(s) associated with Cefdinir (NDC 68180-722). A significant event, classified as Class II, was initiated on May 08, 2024 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Defective container: lack of seal integrity."
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
D-0518-2024D-0497-2024D-0496-2024D-1406-2020D-0306-2020D-0305-2020D-1320-2019D-0376-2019D-0375-2019D-0684-2018
Class II Terminated
Defective container: lack of seal integrity.
May 08, 2024
Jun 05, 2024
51,006 bottles
Recall Profile & Regulatory Data
Event ID
94602
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Apr 29, 2025
Product Description
Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-723-04
Batch or Lot Expiration Information
Lot# F305184, F305185, F305186, Exp 7/31/ 2025
Affected Packages Involved in this Recall
68180-722-20Product
68180-722-10Product
68180-722-04Product
68180-722-05Product
68180-723-20Product
68180-723-10Product
68180-723-04Product
68180-723-05Product
Class II Terminated
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Apr 24, 2024
May 22, 2024
17,040 bottles
Recall Profile & Regulatory Data
Event ID
94492
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Termination Date
Apr 29, 2025
Product Description
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
Batch or Lot Expiration Information
Lot# F305292, Exp 8/30/2025
Affected Packages Involved in this Recall
68180-722-20Product
68180-722-10Product
68180-722-04Product
68180-722-05Product
68180-723-20Product
68180-723-10Product
68180-723-04Product
68180-723-05Product
Class II Terminated
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Apr 24, 2024
May 22, 2024
17,070 bottles
Recall Profile & Regulatory Data
Event ID
94492
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Termination Date
Apr 29, 2025
Product Description
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04
Batch or Lot Expiration Information
Lot# F305442, Exp 8/30/2025
Affected Packages Involved in this Recall
68180-722-20Product
68180-722-10Product
68180-722-04Product
68180-722-05Product
68180-723-20Product
68180-723-10Product
68180-723-04Product
68180-723-05Product
Class II Terminated
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Jul 02, 2020
Jul 29, 2020
35,928 bottles
Recall Profile & Regulatory Data
Event ID
85960
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Jun 30, 2021
Product Description
Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20
Batch or Lot Expiration Information
Lot# F802189, Exp 10/2020, F900240, Exp 1/2021
Affected Packages Involved in this Recall
68180-722-20Product
68180-722-10Product
68180-722-04Product
68180-722-05Product
68180-723-20Product
68180-723-10Product
68180-723-04Product
68180-723-05Product
Class III Terminated
Presence of Foreign substance: identified as a dead ant.
Nov 01, 2019
Nov 13, 2019
a) 4074 bottles b) 30,300 bottles
Recall Profile & Regulatory Data
Event ID
84196
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to major distributors/wholesalers throughout the United States.
Termination Date
Mar 04, 2021
Product Description
Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA
Batch or Lot Expiration Information
Lot# : a) F900153, Exp 11/20; b) F802327, F802328, F802329, Exp 11/20
Affected Packages Involved in this Recall
68180-722-20Product
68180-722-10Product
68180-722-04Product
68180-722-05Product
68180-723-20Product
68180-723-10Product
68180-723-04Product
68180-723-05Product
Class III Terminated
Presence of Foreign substance: identified as a dead ant.
Nov 01, 2019
Nov 13, 2019
30,516 bottles
Recall Profile & Regulatory Data
Event ID
84196
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to major distributors/wholesalers throughout the United States.
Termination Date
Mar 04, 2021
Product Description
Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10
Batch or Lot Expiration Information
Lot# : F802345, F802346, F802347, Exp 11/20
Affected Packages Involved in this Recall
68180-722-20Product
68180-722-10Product
68180-722-04Product
68180-722-05Product
68180-723-20Product
68180-723-10Product
68180-723-04Product
68180-723-05Product
May 2019 Class II Recall: Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Recall Number
Class II Terminated
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
May 23, 2019
Jun 05, 2019
18,408, 60 mL bottles
Recall Profile & Regulatory Data
Event ID
82939
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Oct 22, 2020
Product Description
Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 20201, Manufactured by: Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20
Batch or Lot Expiration Information
Lot# F802335, exp. date November 2020
Affected Packages Involved in this Recall
68180-722-20Product
68180-722-10Product
68180-722-04Product
68180-722-05Product
68180-723-20Product
68180-723-10Product
68180-723-04Product
68180-723-05Product
Class II Terminated
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Jan 02, 2019
Jan 16, 2019
287,784 bottles
Recall Profile & Regulatory Data
Event ID
81888
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jun 26, 2020
Product Description
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Batch or Lot Expiration Information
Lot# a)
Lot# : F700343, F700344, F700345, F700346, F700347,F700376, F700377, F700415, F700146,F700417, F700418, Exp. Jan 2019; F700419, F700420, F700492, F700493,F700508,F700665, Exp. February 2019; F700784, Exp. April 2019; b)
Lot# : F700324, F700325, F700326, Exp. January 2019; F700618, F700619, F700620, Exp. February 2019.
Affected Packages Involved in this Recall
68180-722-20Product
68180-722-10Product
68180-722-04Product
68180-722-05Product
68180-723-20Product
68180-723-10Product
68180-723-04Product
68180-723-05Product
Class II Terminated
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Jan 02, 2019
Jan 16, 2019
287,784 bottles
Recall Profile & Regulatory Data
Event ID
81888
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jun 26, 2020
Product Description
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Batch or Lot Expiration Information
Lot# a)
Lot# : F700329, F700330, F700328, Exp. January 2019; F700544, F700545, F700668, F700669, F700670, Exp. March 2019; F700958, Exp. April 2019 b)
Lot# : F700327, F700392, F700393, Exp. January 2019; F700546, F700547, F700664, Exp. March 2019; F700967, Exp. April 2019, F701106, F701107, F701108, F701109, Exp. May 2019.
Affected Packages Involved in this Recall
68180-722-20Product
68180-722-10Product
68180-722-04Product
68180-722-05Product
68180-723-20Product
68180-723-10Product
68180-723-04Product
68180-723-05Product
Class II Terminated
Superpotent Drug
Mar 27, 2018
Apr 25, 2018
40,824 bottles
Recall Profile & Regulatory Data
Event ID
79612
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 15, 2019
Product Description
Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
Batch or Lot Expiration Information
Lot# F602241; Exp. 10/18
Lot# F602577; Exp. 11/18
Lot# F700036; Exp. 12/18
Affected Packages Involved in this Recall
68180-722-20Product
68180-722-10Product
68180-722-04Product
68180-722-05Product
68180-723-20Product
68180-723-10Product
68180-723-04Product
68180-723-05Product
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.
