Records and reported status
Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmac... Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmac... Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmac... Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmac... Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmac... Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharma... Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC... Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC... Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC... Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC... Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC... Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC... Jan 29, 2025 FDA drug enforcement
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide within the U.S
Official source for Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LL... Jan 22, 2025 FDA drug enforcement
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide in the U.S
Official source for Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 684... Jan 22, 2025 FDA drug enforcement
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Class II Reported ongoing
Distribution: Nationwide in the U.S
Official source for Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 6... Dec 11, 2024 FDA drug enforcement
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II Reported ongoing
Distribution: USA Nationwide
Official source for chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Gle... Dec 11, 2024 FDA drug enforcement
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Class II Reported ongoing
Distribution: USA Nationwide
Official source for chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Gl... Nov 1, 2024 FDA drug enforcement
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Ca... Nov 1, 2024 FDA drug enforcement
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured... Nov 1, 2024 FDA drug enforcement
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufacture...
Reasons in these listed records CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit. CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit. cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit. These examples come from this result page and are not a ranking of every recall reason.
Checking Glenmark Pharmaceuticals Inc., USA Is there a recall on glenmark pharmaceuticals inc., usa right now? This archive contains 116 records, including 105 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records? Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.