CLASS II Drug recall · Reported 15 Mar 2017 · FDA Enforcement Report
Mirtazapine Tablets, USP, 45 mg recalled by Mylan Institutional, Inc.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Mirtazapine Tablets, USP, 45 mg, distributed nationwide in the US. The recall was initiated on 27 Jan 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0493-2017
- FDA event ID
- 76463
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL
- Brand
- Mirtazapine
- Manufacturer
- Mylan Institutional Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jan 2017
- FDA classified
- 8 Mar 2017
- Reported
- 15 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 27 Jan 2017 | Recall initiated by company | |
| 8 Mar 2017 | Classified by FDA | +40 days |
| 15 Mar 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Product as listed by the FDA
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Which lots are affected?
Batch #3083289; Exp. Date 12/2018
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
All 22Other Mirtazapine recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirtazapine Tablets, USP 15mg recalled by Aurobindo Pharma USAMirtazapine | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Mirtazapine Tablets recalled by AuroMedics PharmaMirtazapine | AuroMedics Pharma | Other | Nationwide |
| Drug | CLASS I | Mirtazapine Tablets recalled by AuroMedics PharmaMirtazapine | AuroMedics Pharma | Other | Nationwide |
| Drug | CLASS II | Mirtazapine Tablets, USP 45 mg, a), b) and c) recalledMirtazapine | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Mirtazapine Tablet, 7.5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |