RecallRadar

FDA Drug recall D-0492-2017

Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV

On 2017-03-15 the FDA classified a Class II recall of Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV by Mylan Pharmaceuticals, citing presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0492-2017
ClassificationClass II
Statusterminated
Initiated2017-01-19
Published2017-03-15
Last updated2026-09-13 11:51 UTC
CompanyMylan Pharmaceuticals
DistributionUS

Product

Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV

Reason

Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle

Identifiers

ndc0378-3515-70
ndc0378-3515-93
ndc0378-3515-01
ndc0378-3515-10
ndc0378-3530-70
ndc0378-3530-93
ndc0378-3530-01
ndc0378-3530-05
ndc0378-3545-70
ndc0378-3545-93
ndc0378-3545-01
ndc0378-3545-05
code_infoa) 3078937 and 3078938 (NDC 0378-3545-93), exp August 2019 b) 3078937 (NDC 0378-3545-01), exp August 2019 c) 3078936 (0378-3545-05), exp August 2019

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0492-2017%22

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