Amoxicillin Capsule
FDA Recall NDC 0781-2613
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 Amoxicillin (NDC 0781-2613). A significant event, classified as Class II, was initiated on Apr 13, 2022 by Sandoz Inc. The reported reason for this action was: "cGMP deviations: Temperature abuse"
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
Class II Terminated
cGMP deviations: Temperature abuse
Apr 13, 2022
Jun 15, 2022
12 bottles
Recall Profile & Regulatory Data
Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0781-2613-01
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
0781-2020-31Product
0781-2020-76Product
0781-2020-01Product
0781-2020-05Product
0781-2613-31Product
0781-2613-76Product
0781-2613-01Product
0781-2613-05Product
0781-5060-20Product
0781-5060-01Product
0781-5061-20Product
0781-5061-01Product
0781-6039-58Product
0781-6039-46Product
0781-6039-55Product
0781-6156-52Product
0781-6156-57Product
0781-6156-46Product
0781-6041-58Product
0781-6041-46Product
0781-6041-55Product
0781-6157-52Product
0781-6157-57Product
0781-6157-46Product
Class II Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Jan 26, 2022
Jan 03, 2024
2 units
Recall Profile & Regulatory Data
Event ID
89450
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
CARDINAL HEALTHCARE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 29, 2024
Product Description
AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20
Batch or Lot Expiration Information
Batch# Batch LJ9004
Affected Packages Involved in this Recall
0781-2020-31Product
0781-2020-76Product
0781-2020-01Product
0781-2020-05Product
0781-2613-31Product
0781-2613-76Product
0781-2613-01Product
0781-2613-05Product
0781-5060-20Product
0781-5060-01Product
0781-5061-20Product
0781-5061-01Product
0781-6039-58Product
0781-6039-46Product
0781-6039-55Product
0781-6156-52Product
0781-6156-57Product
0781-6156-46Product
0781-6041-58Product
0781-6041-46Product
0781-6041-55Product
0781-6157-52Product
0781-6157-57Product
0781-6157-46Product
April 2013 Class II Recall: Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
Recall Number
Class II Terminated
Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
Apr 18, 2013
May 01, 2013
8286 x 30 ct, 37108 x 500 ct. bottles
Recall Profile & Regulatory Data
Event ID
64936
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sandoz Incorporated
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 26, 2014
Product Description
Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.
Batch or Lot Expiration Information
Lot# CK2003, CK2004 exp. 04/15, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994 exp. 07/15, CK3616, CK3617 exp. 04/15
Affected Packages Involved in this Recall
0781-2020-31Product
0781-2020-76Product
0781-2020-01Product
0781-2020-05Product
0781-2613-31Product
0781-2613-76Product
0781-2613-01Product
0781-2613-05Product
0781-5060-20Product
0781-5060-01Product
0781-5061-20Product
0781-5061-01Product
0781-6039-58Product
0781-6039-46Product
0781-6039-55Product
0781-6156-52Product
0781-6156-57Product
0781-6156-46Product
0781-6041-58Product
0781-6041-46Product
0781-6041-55Product
0781-6157-52Product
0781-6157-57Product
0781-6157-46Product
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.
