Food, drugs, devices › Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Drug recall: Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Mo
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) (Rockford, IL) initiated this drug recall on 1 May 2018; FDA lists 2 product records under event 79977, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 10 Mar 2021. Initiation: voluntary: firm initiated. Mylan Institutional, Inc. (d.b.a. UDL Laboratories) has 16 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL.
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"
Distribution
"Nationwide in the U.S."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0822-2018 | Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20 | 1,065 blister cards of 100 capsules each | Class II | Terminated | 30 May 2018 |
| D-0823-2018 | 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. | 1,152 blister cards of 100 capsules each | Class II | Terminated | 30 May 2018 |
Context
Other enforcement events for Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
All 16 events for Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide in the U.S."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Mar 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.