Montelukast recalls

Recall records

Class II2023-11-15Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.Recalling firm: Dr. Reddy's Laboratories, Inc.Read what it means & check your lot →Class II2023-05-10Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30CGMP deviations.Recalling firm: PD-Rx Pharmaceuticals, Inc.Read what it means & check your lot →Class III2023-04-12Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.Recalling firm: Teva Pharmaceuticals USA IncRead what it means & check your lot →Class II2023-04-12Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.Recalling firm: Preferred Pharmaceuticals, Inc.Read what it means & check your lot →Class II2023-04-05Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534cGMP deviationsRecalling firm: Direct RxRead what it means & check your lot →Class II2023-03-08Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3; c) 1,000-count bottle NDC 16729-119-17 UPC 3 16729 11917 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIACGMP Deviations: recalling drug products following an FDA inspection.Recalling firm: Accord Healthcare, Inc.Read what it means & check your lot →Class III2020-02-05Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10Failed Dissolution Specifications: testing revealed low out of specification result in one lot of productRecalling firm: Macleods Pharma Usa IncRead what it means & check your lot →Class II2018-10-03Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.Recalling firm: Hetero Labs Limited Unit VRead what it means & check your lot →Class I2018-10-03Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.Recalling firm: Hetero Labs Limited Unit VRead what it means & check your lot →Class III2017-06-21Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total ImpuritiesRecalling firm: Mylan Pharmaceuticals Inc.Read what it means & check your lot →Class III2017-04-05Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.Recalling firm: Hetero USA IncRead what it means & check your lot →Class II2015-04-29Montelukast Sodium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, CanadaPenicillin 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 withRecalling firm: Attix PharmaceuticalsRead what it means & check your lot →Class II2014-01-29MONTELUKAST SODIUM, CHEW Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006071131.Labeling: Label Mixup: MONTELUKAST SODIUM, CHEW Tablet, 4 mg may be potentially mislabeled as the following drug: DICYCLOMINE HCL, Tablet, 20 mg, NDC 00591079501, Pedigree: AD76639Recalling firm: Aidapak Services, LLCRead what it means & check your lot →Class III2013-03-13Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430.Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moRecalling firm: Glenmark Generics Inc., USARead what it means & check your lot →

Is Montelukast still recalled?

An FDA status of “Terminated” or “Completed” is an administrative state — FDA closed the recall action, not a statement about your bottle. Match the lot number on your medicine to the records above, and ask your pharmacist.

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Source: U.S. FDA enforcement database (openFDA), checked live. Each record links to its FDA source. Not medical advice.