Food, drugs, devices › Mylan Pharmaceuticals Inc.

Drug recall: Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01

FDA enforcement event 79955 · Class II · initiated 24 Apr 2018 · status Terminated · terminated 14 Aug 2019

DrugVoluntary: Firm initiated2 product recordsMorgantown, WV

Mylan Pharmaceuticals Inc. (Morgantown, WV) initiated this drug recall on 24 Apr 2018; FDA lists 2 product records under event 79955, 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 14 Aug 2019. Initiation: voluntary: firm initiated. Mylan Pharmaceuticals Inc. has 55 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 Pharmaceuticals Inc., Morgantown, WV.

Reason for recall

"CGMP Deviations"

Distribution

"Product was distributed throughout the United States, including Puerto Rico."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0824-2018	Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01	8,679 bottles	Class II	Terminated	30 May 2018
D-0825-2018	Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01	11,650 bottles	Class II	Terminated	30 May 2018

Context

60%of 2018 drug events are Class II367 events that year

2product records in this eventfirm median: 1

55events on this register for the firm

Other enforcement events for Mylan Pharmaceuticals Inc.

Initiated	Product (first record)	Type	Class	Records
26 Aug 2026	Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured	Drug	Class II	1
17 Aug 2026	Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morganto	Drug	Class II	1
24 Jul 2026	Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufact	Drug	Class II	1
2 Jul 2026	Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: M	Drug	Class II	1
24 Feb 2026	Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: My	Drug	Class II	1
25 Feb 2025	Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 265	Drug	Class II	1
5 Jul 2022	Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packag	Drug	Class I	1
12 Apr 2022	Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside	Drug	Class I	1
7 Apr 2022	Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morga	Drug	Class II	1
1 Apr 2022	Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morga	Drug	Class II	1

All 55 events for Mylan Pharmaceuticals Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "CGMP Deviations"

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: "Product was distributed throughout the United States, including Puerto Rico."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 14 Aug 2019. "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.