PlainRecalls

Search Recalls

Search our full database of product recalls from FDA, CPSC, NHTSA, and USDA. Find recalls by product name, brand, manufacturer, hazard type, or keyword.

PlainRecalls indexes tens of thousands of recall records across multiple federal agencies. Use the search box below to find specific products or browse by agency, category, or date on the respective listing pages. Search results include the recall title, the recalling firm, severity classification, and the date the recall was announced.

Found 16 recalls matching "montelukast"

FDA Drug Moderate Nov 15, 2023

Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC…

Dr. Reddy's Laboratories, Inc.

FDA Drug Moderate May 10, 2023

Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Okl…

PD-Rx Pharmaceuticals, Inc.

FDA Drug Low Apr 12, 2023

Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Pars…

Teva Pharmaceuticals USA Inc

FDA Drug Moderate Apr 12, 2023

Montelukast 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…

Preferred Pharmaceuticals, Inc.

FDA Drug Moderate Apr 5, 2023

Montelukast 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; P…

Direct Rx

FDA Drug Moderate Mar 8, 2023

Montelukast 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 16729-1…

Accord Healthcare, Inc.

FDA Drug Low Feb 5, 2020

Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Ma…

Macleods Pharma Usa Inc

FDA Drug Moderate Oct 3, 2018

Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 3…

Hetero Labs Limited Unit V

FDA Drug Critical Oct 3, 2018

Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, I…

Hetero Labs Limited Unit V

FDA Drug Low Jun 21, 2017

Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93

Mylan Pharmaceuticals Inc.

FDA Drug Low Apr 5, 2017

Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Li…

Hetero USA Inc

FDA Drug Moderate Sep 21, 2016

Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 Nort…

Aurobindo Pharma USA Inc

FDA Drug Moderate Apr 29, 2015

Montelukast Sodium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, U…

Attix Pharmaceuticals

FDA Drug Moderate Jan 29, 2014

PERPHENAZINE, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603506321.

Aidapak Services, LLC

FDA Drug Moderate Jan 29, 2014

MONTELUKAST SODIUM, CHEW Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006071131.

Aidapak Services, LLC

FDA Drug Low Mar 13, 2013

Montelukast 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…

Glenmark Generics Inc., USA

How PlainRecalls Search Works

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Information surfaced here is drawn from public sources, but individual records can contain clerical errors, may lag real-world changes, or may be incomplete for historical reasons. Before making any consequential decision — legal, medical, financial, employment, safety-related — you should verify the underlying fact directly with the issuing agency. PlainRecalls does not render professional advice, does not rank or endorse individual records, and does not accept paid placement. We surface public data faithfully and explain it in clear language; how you act on the information is your responsibility and, when the stakes are high, the responsibility of a licensed professional you consult.

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