Food, drugs, devices › Mylan Pharmaceuticals Inc.
Drug recall: Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown
Mylan Pharmaceuticals Inc. (Morgantown, WV) initiated this drug recall on 19 Jun 2014; FDA lists 1 product record under event 68645, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 27% of the 313 drug enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 23 Jul 2015. 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
"Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1557-2014 | Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05. | 2,658 Bottles | Class III | Terminated | 3 Sep 2014 |
Context
Other enforcement events for Mylan Pharmaceuticals Inc.
All 55 events for Mylan Pharmaceuticals Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 Jul 2015. "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.