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Alembic Pharmaceuticals Limited

Pharmaceutical company8 products tracked
8
products tracked
283,448
total reports
19
recalls on record
66.7%
serious overall
Products
showing 8 of 8
ProductApprovedReports ↓Top signalRecalls
201078,131Haemorrhagic anaemia5
—69,814Drug reaction with eosinophilia and systemic symptoms0
—59,849Lower respiratory tract infection0
200941,144Renal haemangioma0
198713,393Macular degeneration13
20119,105Abnormal dreams0
—8,068Intraocular pressure increased0
19963,944Infusion site pain1
Recall history · 19 on record
DateClassReasonFirm
Feb 17, 2026IIDefective container; inadequately sealed blister packaging.The Harvard Drug Group LLC
Dec 16, 2025IIIFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.Alembic Pharmaceuticals Limited
Oct 10, 2025IIIFailed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.Alembic Pharmaceuticals Limited
Jul 25, 2025IICGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.Alembic Pharmaceuticals Limited
May 9, 2025IIPresence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsuleAlembic Pharmaceuticals Limited
Dec 12, 2024IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limitAscend Laboratories, LLC
Dec 12, 2024IICGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limitAscend Laboratories, LLC
Aug 30, 2024IISubpotent DrugGlenmark Pharmaceuticals Inc., USA
Mar 14, 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
Mar 14, 2023IICGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.Ascend Laboratories, LLC
Apr 13, 2022IIcGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office
Jun 10, 2020IILabeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.Alembic Pharmaceuticals Limited
Jul 18, 2016IIPenicillin Cross ContaminationGlaxoSmithKline, LLC
Jul 18, 2016IIPenicillin Cross ContaminationGlaxoSmithKline, LLC
Jul 18, 2016IIPenicillin Cross ContaminationGlaxoSmithKline, LLC
Aug 13, 2015IIPenicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.GlaxoSmithKline, LLC.
Aug 13, 2015IIPenicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.GlaxoSmithKline, LLC.
Nov 14, 2014IIPenicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.Attix Pharmaceuticals
Nov 5, 2012IIDefective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the productBoehringer Ingelheim Roxane Inc

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from Alembic Pharmaceuticals Limited are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.