Ibu Tablet
FDA Recall NDC 55111-683
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Ibu (NDC 55111-683). A significant event, classified as Class III, was initiated on Oct 29, 2024 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Failed Tablet/Capsule Specifications"
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
Class III Ongoing
Failed Tablet/Capsule Specifications
Oct 29, 2024
Nov 27, 2024
3416 botttles
Recall Profile & Regulatory Data
Event ID
95620
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product Description
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
Batch or Lot Expiration Information
Lot# : C5406201, Exp 03/31/2028
Affected Packages Involved in this Recall
55111-682-09Product
55111-682-01Product
55111-682-05Product
55111-683-30Product
55111-683-50Product
55111-683-09Product
55111-683-01Product
55111-683-05Product
55111-684-30Product
55111-684-50Product
55111-684-60Product
55111-684-09Product
55111-684-01Product
55111-684-05Product
Class II Ongoing
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Aug 06, 2024
Sep 04, 2024
14940 bottles
Recall Profile & Regulatory Data
Event ID
95098
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Product Description
IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.
Batch or Lot Expiration Information
Lot# a)NDC 55111-682-01 Lots C2207529, Exp 5/31/2026; C2210993, Exp 9/30/2026. b)NDC 55111-682-05 Lots C2207530, Exp 5/31/2026; C2210992, C2210994, Exp 9/30/2026; C2213304, C2213305, Exp 11/30/2026.
Affected Packages Involved in this Recall
55111-682-09Product
55111-682-01Product
55111-682-05Product
55111-683-30Product
55111-683-50Product
55111-683-09Product
55111-683-01Product
55111-683-05Product
55111-684-30Product
55111-684-50Product
55111-684-60Product
55111-684-09Product
55111-684-01Product
55111-684-05Product
Class II Ongoing
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Aug 06, 2024
Sep 04, 2024
103,298 bottles
Recall Profile & Regulatory Data
Event ID
95098
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Product Description
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.
Batch or Lot Expiration Information
Lot# a) NDC 55111-684-01 Lots C2207525, Exp 5/31/2026; C2212902, Exp 11/30/2026. b) NDC 55111-684-05 Lots C2207526, Exp 5/31/2026; C2210751, C2210752, Exp 9/30/2026; C2212765, C2212766, Exp 11/30/2026; C2301027, C2301063, C2301187, C2301188, C2301247, Exp 12/31/2026; C2301356, C2301388, C2301494, C2301478, C2301617, Exp 1/31/2027; C2303381, C2303432, C2303565, C2303630, C2303643, C2303710, Exp 2/28/2027; C2303879, C2303806, C2303895, C2303963, C2304263, C2304264, C2304130, C2304163, C2304427, Exp 3/31/2027.
Affected Packages Involved in this Recall
55111-682-09Product
55111-682-01Product
55111-682-05Product
55111-683-30Product
55111-683-50Product
55111-683-09Product
55111-683-01Product
55111-683-05Product
55111-684-30Product
55111-684-50Product
55111-684-60Product
55111-684-09Product
55111-684-01Product
55111-684-05Product
Class II Ongoing
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Aug 06, 2024
Sep 04, 2024
31,802 bottles
Recall Profile & Regulatory Data
Event ID
95098
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Product Description
IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle.
Batch or Lot Expiration Information
Lot# a)NDC 55111-683-01 Lots C2207527, Exp 5/31/2026; C2210864, Exp 9/30/2026; C2213018, Exp 11/30/2026. b)NDC 5511-683-05 Lots C2207528, Exp 5/31/2026; C2210860, Exp 9/30/2026; C2213016, C2213017, Exp 11/30/2026; C2301852, C2302056, C2302057, Exp 1/31/2027.
Affected Packages Involved in this Recall
55111-682-09Product
55111-682-01Product
55111-682-05Product
55111-683-30Product
55111-683-50Product
55111-683-09Product
55111-683-01Product
55111-683-05Product
55111-684-30Product
55111-684-50Product
55111-684-60Product
55111-684-09Product
55111-684-01Product
55111-684-05Product
Class II Terminated
Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.
Aug 29, 2013
Sep 25, 2013
18852 bottles
Recall Profile & Regulatory Data
Event ID
66117
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide (& Puerto Rico)
Termination Date
Mar 20, 2014
Product Description
IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA.
Batch or Lot Expiration Information
Lot# L300192; Exp. 05/2017
Affected Packages Involved in this Recall
55111-682-09Product
55111-682-01Product
55111-682-05Product
55111-683-30Product
55111-683-50Product
55111-683-09Product
55111-683-01Product
55111-683-05Product
55111-684-30Product
55111-684-50Product
55111-684-60Product
55111-684-09Product
55111-684-01Product
55111-684-05Product
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.
