CLASS II Drug recall · Reported 30 May 2018 · FDA Enforcement Report
Loxapine Capsules, USP 50 mg recalled by Mylan Institutional, Inc.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Loxapine Capsules, USP 50 mg, distributed nationwide in the US. The recall was initiated on 1 May 2018 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-0823-2018
- FDA event ID
- 79977
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 May 2018
- FDA classified
- 22 May 2018
- Reported
- 30 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 1 May 2018 | Recall initiated by company | |
| 22 May 2018 | Classified by FDA | +21 days |
| 30 May 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Product as listed by the FDA
Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Which lots are affected?
Lot #: 3092310, Exp. 03/2019
Where was it sold?
Nationwide in the U.S.
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.
Other products in this recall event
1 other product · FDA event 79977| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Loxapine Capsules, USP 25 mg recalled by Mylan Institutional, Inc. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
All 22Other Loxapine recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Loxapine Capsules, USP 25 mg recalled by Mylan Pharmaceuticals | Mylan Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Loxapine Capsules, USP 25 mg recalled by Mylan Institutional, Inc. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Loxapine Capsules, USP 50 mg recalled by Mylan Pharmaceuticals | Mylan Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Loxapine, Capsule, 5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS III | Loxapine Capsules USP, 25mg recalled by Watson LaboratoriesLoxapine | Watson Laboratories | Packaging Defects | Nationwide |