Metformin Hydrochloride Tablet, Extended Release
FDA Recall NDC 65162-178
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Metformin Hydrochloride (NDC 65162-178). A significant event, classified as Class II, was initiated on May 29, 2020 by Amneal Pharmaceuticals Llc. The reported reason for this action was: "CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level"
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 II Ongoing
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
May 29, 2020
Jul 01, 2020
N/A
Recall Profile & Regulatory Data
Event ID
85781
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-50
Batch or Lot Expiration Information
Lot# AM180641A 6/30/2020 AM180642A 6/30/2020 AM180643A 6/30/2020 AM180644A 6/30/2020 AM180645A 6/30/2020 AM180646A 6/30/2020 AM180647A 6/30/2020 AM180880A 7/31/2020 AM180881A 7/31/2020 AM180882A 7/31/2020 AM180883A 7/31/2020 AM180884A 7/31/2020 AM180885A 7/31/2020 AM180886A 7/31/2020 AM180887A 7/31/2020 AM180888A 7/31/2020 AM180889A 7/31/2020 AM180936A 7/31/2020 AM180937A 7/31/2020 AM180938A 7/31/2020 AM180939A 7/31/2020 AM180940A 7/31/2020 AM180960A 7/31/2020 AM180961A 7/31/2020 AM180962A 7/31/2020 AM180963A 7/31/2020 AM180964A 7/31/2020 AM180965A 7/31/2020 AM180992A 7/31/2020 AM180993A 7/31/2020 AM180994A 8/31/2020 AM180995A 8/31/2020 AM180996A 8/31/2020 AM180997A 8/31/2020 AM181037A 8/31/2020 AM181038A 8/31/2020 AM181039A 8/31/2020 AM181040A 8/31/2020 AM181041A 8/31/2020 AM181079A 8/31/2020 AM181080A 8/31/2020 AM181081A 8/31/2020 AM181082A 8/31/2020 AM181083A 8/31/2020 AM181084A 8/31/2020 AM181085A 8/31/2020 AM181086A 8/31/2020 AM181087A 8/31/2020 AM181088A 8/31/2020 AM181089A 8/31/2020 AM181093A 8/31/2020 AM181094A 8/31/2020 AM181095A 8/31/2020 AM181096A 8/31/2020 AM181097A 8/31/2020 AM181098A 8/31/2020 AM181099A 8/31/2020 AM181100A 8/31/2020 AM181101A 8/31/2020 AM181102A 8/31/2020 AM181116A 8/31/2020 AM181117A 9/30/2020 AM181129A 8/31/2020 AM181130A 8/31/2020 AM181131A 8/31/2020 AM181132A 8/31/2020 AM181133A 9/30/2020 AM181134A 9/30/2020 AM181135A 9/30/2020 AM181136A 9/30/2020 AM181137A 9/30/2020 AM181138A 9/30/2020 AM181183A 9/30/2020 AM181184A 9/30/2020 AM181185A 9/30/2020 AM181186A 9/30/2020 AM181187A 9/30/2020 AM181188A 9/30/2020 AM181189A 9/30/2020 AM181190A 9/30/2020 AM181235A 9/30/2020 AM181236A 9/30/2020 AM181237A 9/30/2020 AM181238A 9/30/2020 AM181239A 9/30/2020 AM181240A 9/30/2020 AM181242A 9/30/2020 AM181243A 9/30/2020 AM181314A 10/31/2020 AM181315A 11/30/2020 AM190121B 12/31/2020 AM190122B 12/31/2020 AM190713AA 6/30/2021 AM191248A 10/31/2021 AM191249A 10/31/2021 AM200192 1/31/2022 AM200322A 2/28/2022
Affected Packages Involved in this Recall
65162-178-89Product
65162-178-03Product
65162-178-09Product
65162-178-10Product
65162-178-50Product
65162-178-11Product
65162-179-03Product
65162-179-09Product
65162-179-10Product
65162-179-50Product
Class II Ongoing
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
May 29, 2020
Jul 01, 2020
N/A
Recall Profile & Regulatory Data
Event ID
85781
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10
Batch or Lot Expiration Information
Lot# AM181337A 10/31/2020 AM181338A 10/31/2020 AM181339A 11/30/2020 AM181340A 11/30/2020 AM181341A 11/30/2020 AM181342A 11/30/2020 AM181343A 11/30/2020 AM181344A 11/30/2020 AM181356A 11/30/2020 AM181357A 11/30/2020 AM181358A 11/30/2020 AM181359A 11/30/2020 AM181360A 11/30/2020 AM181361A 11/30/2020 AM181362A 11/30/2020 AM181363A 11/30/2020 AM181415A 11/30/2020 AM190040B 12/31/2020 AM190041A 12/31/2020 AM190042A 12/31/2020 AM190043A 12/31/2020 AM190044A 12/31/2020 AM190045A 12/31/2020 AM190046A 12/31/2020 AM190473B 4/30/2021 AM190474A 4/30/2021 AM190475A 4/30/2021 AM190476A 4/30/2021 AM190477A 4/30/2021 AM190478A 4/30/2021 AM190479A 4/30/2021 AM190480A 4/30/2021 AM190481A 4/30/2021 AM190482A 4/30/2021 AM190834A 7/31/2021 AM190835A 7/31/2021 AM190836A 7/31/2021 AM190837A 7/31/2021 AM190838A 7/31/2021 AM191004A 8/31/2021 AM191005A 8/31/2021 AM191006A 8/31/2021 AM191007A 8/31/2021 AM191008A 9/30/2021 AM191271A 10/31/2021 AM191272A 10/31/2021 AM191273A 10/31/2021 AM191274A 10/31/2021 AM191338A 11/30/2021 AM191339A 11/30/2021 AM191340A 11/30/2021 AM191341 12/31/2021 AM191342 12/31/2021 AM200109 12/31/2021 AM200110 12/31/2021 AM200111 12/31/2021
Affected Packages Involved in this Recall
65162-178-89Product
65162-178-03Product
65162-178-09Product
65162-178-10Product
65162-178-50Product
65162-178-11Product
65162-179-03Product
65162-179-09Product
65162-179-10Product
65162-179-50Product
Class II Ongoing
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
May 29, 2020
Jul 01, 2020
N/A
Recall Profile & Regulatory Data
Event ID
85781
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-10
Batch or Lot Expiration Information
Lot# AM181118AA 10/31/2020 AM181191AA 9/30/2020 AM181192AA 9/30/2020 AM181235AA 9/30/2020 AM181236AA 9/30/2020 AM181237AA 9/30/2020 AM181240AA 9/30/2020 AM181241AA 9/30/2020 AM181242AA 9/30/2020 AM181243AA 9/30/2020 AM181244AA 10/31/2020 AM181268AA 10/31/2020 AM181269AA 10/31/2020 AM181270AA 10/30/2020 AM181271AA 10/31/2020 AM181272AA 10/31/2020 AM181273AA 10/31/2020 AM181274AA 10/31/2020 AM181275AA 10/31/2020 AM181276AA 10/31/2020 AM181277AA 10/31/2020 AM181307AA 10/31/2020 AM181308AA 10/31/2020 AM181309AA 10/31/2020 AM181310AA 10/31/2020 AM181311AA 10/31/2020 AM181313AA 10/31/2020 AM181314AA 10/31/2020 AM181315AA 11/30/2020 AM181316AA 11/30/2020 AM181317AA 12/31/2020 AM181419AA 11/30/2020 AM181420AA 11/30/2020 AM181421AA 11/30/2020 AM181422AA 11/30/2020 AM181423AA 11/30/2020 AM181424AA 11/30/2020 AM181425AA 11/30/2020 AM181430BA 12/31/2020 AM181455AA 12/31/2020 AM181456AA 12/31/2020 AM181457AA 12/31/2020 AM181458AA 12/31/2020 AM181459AA 12/31/2020 AM181460AA 12/31/2020 AM181461AA 12/31/2020 AM181462AA 12/31/2020 AM181463AA 12/31/2020 AM181464AA 12/31/2020 AM181465AA 12/31/2020 AM190054AA 12/31/2020 AM190055AA 12/31/2020 AM190057AA 12/31/2020 AM190058AA 12/31/2020 AM190102AA 12/31/2020 AM190103AA 12/31/2020 AM190104AA 12/31/2020 AM190105AA 12/31/2020 AM190106AA 12/31/2020 AM190107AA 12/31/2020 AM190108AA 12/31/2020 AM190120AA 12/31/2020 AM190633AA 5/31/2021 AM190634AA 5/31/2021 AM190635AA 5/31/2021 AM190636AA 5/31/2021 AM190637AA 5/31/2021 AM190638AA 5/31/2021 AM190640AA 5/31/2021 AM190641AA 5/31/2021 AM190642AA 5/31/2021 AM190664AA 5/31/2021 AM190665AA 5/31/2021 AM190666AA 5/31/2021 AM190667AA 5/31/2021 AM190668AA 5/31/2021 AM190669AA 6/30/2021 AM190670AA 6/30/2021 AM190671AA 6/30/2021 AM190672AA 6/30/2021 AM190714AA 6/30/2021 AM190934A 8/31/2021 AM190991A 8/31/2021 AM190992A 8/31/2021 AM190993A 8/31/2021 AM190994A 8/31/2021 AM191040A 9/30/2021 AM191041A 9/30/2021 AM191083A 9/30/2021 AM191084A 9/30/2021 AM191085A 9/30/2021 AM191091A 9/30/2021 AM191092A 9/30/2021 AM191105A 9/30/2021 AM191106A 10/31/2021 AM191107A 10/31/2021 AM191109A 10/31/2021 AM191186A 10/31/2021 AM191187A 10/31/2021 AM191188A 10/31/2021 AM191189A 10/31/2021 AM191190A 10/31/2021 AM191191A 10/31/2021 AM191192A 10/31/2021 AM191193A 10/31/2021 AM191194A 10/31/2021 AM191195A 10/31/2021 AM191244A 10/31/2021 AM191245A 10/31/2021 AM191246A 10/31/2021 AM191247A 10/31/2021 AM191294A 11/30/2021 AM191295A 11/30/2021 AM191296A 11/30/2021 AM191365A 11/30/2021 AM191366A 11/30/2021 AM191367A 11/30/2021 AM191392A 11/30/2021 AM191393A 11/30/2021 AM191394A 11/30/2021 AM191395A 12/31/2021 AM200001A 12/31/2021 AM200002A 12/31/2021 AM200003A 12/31/2021 AM200004A 12/31/2021 AM200005A 12/31/2021 AM200006A 12/31/2021 AM200045A 12/31/2021 AM200046A 12/31/2021 AM200047A 12/31/2021 AM200048A 12/31/2021 AM200049A 12/31/2021 AM200050A 12/31/2021 AM200051A 12/31/2021 AM200052A 12/31/2021 AM200053A 12/31/2021 AM200081A 12/31/2021 AM200082A 12/31/2021 AM200083 12/31/2021 AM200087A 12/31/2021 AM200088A 12/31/2021 AM200089 12/31/2021 AM200090 12/31/2021 AM200091 12/31/2021 AM200100 1/31/2022 AM200101 1/31/2022 AM200102 1/31/2022 AM200138 1/31/2022 AM200139 1/31/2022 AM200140 1/31/2022 AM200141 1/31/2022 AM200142 1/31/2022 AM200143 1/31/2022 AM200144 1/31/2022 AM200193 1/31/2022 AM200194 1/31/2022 AM200195 1/31/2022 AM200196 1/31/2022 AM200197 1/31/2022 AM200198 1/31/2022 AM200199 1/31/2022 AM200200 1/31/2022 AM200202 1/31/2022 AM200203 1/31/2022 AM200204 1/31/2022 AM200205 1/31/2022 AM200206 1/31/2022 AM200207 1/31/2022 AM200208 1/31/2022 AM200209 1/31/2022 AM200210 1/31/2022 AM200211 1/31/2022 AM200284 2/28/2022 AM200285 2/28/2022 AM200287 2/28/2022 AM200288 2/28/2022 AM200289 2/28/2022 AM200290 2/28/2022 AM200291 2/28/2022 AM200292 2/28/2022
Affected Packages Involved in this Recall
65162-178-89Product
65162-178-03Product
65162-178-09Product
65162-178-10Product
65162-178-50Product
65162-178-11Product
65162-179-03Product
65162-179-09Product
65162-179-10Product
65162-179-50Product
Class II Ongoing
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
May 29, 2020
Jul 01, 2020
N/A
Recall Profile & Regulatory Data
Event ID
85781
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08907 NDC 65162-178-09
Batch or Lot Expiration Information
Lot# AM190123A 1/31/2021 AM190193A 1/31/2021 AM190194A 1/31/2021 AM190195A 1/31/2021 AM190196A 1/31/2021 AM190197A 1/31/2021 AM190198A 1/31/2021 AM190199A 1/31/2021 AM190200A 2/28/2021 AM190201A 2/28/2021 AM190202A 2/28/2021 AM190269A 2/28/2021 AM190270A 2/28/2021 AM190271A 2/28/2021 AM190272A 2/28/2021 AM190289A 2/28/2021 AM190290A 2/28/2021 AM190291A 2/28/2021 AM190292A 2/28/2021 AM190293A 2/28/2021 AM190294A 2/28/2021 AM190549A 4/30/2021 AM190550A 4/30/2021 AM190551A 4/30/2021 AM190552A 4/30/2021 AM190553A 4/30/2021 AM190554A 4/30/2021 AM190555A 5/31/2021 AM190556A 5/31/2021 AM190586A 5/31/2021 AM190587A 5/31/2021 AM190588A 5/31/2021 AM190589A 5/31/2021 AM190590A 5/31/2021 AM190605A 5/31/2021 AM190673A 6/30/2021 AM190707A 6/30/2021 AM190708A 6/30/2021 AM190709A 6/30/2021 AM190710A 6/30/2021 AM190714C 6/30/2021 AM190751C 6/30/2021 AM190752C 6/30/2021 AM190753A 8/31/2021 AM190754A 8/31/2021 AM190755A 8/31/2021 AM190756A 8/31/2021 AM190757A 8/31/2021 AM190929A 8/31/2021 AM190930A 8/31/2021 AM190931A 8/31/2021 AM190932A 8/31/2021 AM190933A 8/31/2021 AM190995A 8/31/2021 AM191000A 8/31/2021 AM191001A 8/31/2021 AM191002A 8/31/2021 AM191003A 8/31/2021 AM191034A 9/30/2021 AM191035A 9/30/2021 AM191036A 9/30/2021 AM191037A 9/30/2021 AM191038A 9/30/2021 AM191039A 9/30/2021 AM191086A 9/30/2021
Affected Packages Involved in this Recall
65162-178-89Product
65162-178-03Product
65162-178-09Product
65162-178-10Product
65162-178-50Product
65162-178-11Product
65162-179-03Product
65162-179-09Product
65162-179-10Product
65162-179-50Product
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.
