CLASS III Drug recall · Reported 23 Jul 2014 · FDA Enforcement Report
Diltiazem HCl Extended-release Capsules, USP, 120 mg recalled
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Diltiazem HCl Extended-release Capsules, USP, 120 mg, distributed nationwide in the US. The recall was initiated on 3 Jul 2014 and the FDA has classified it as Class III.
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-1435-2014
- FDA event ID
- 68787
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Jul 2014
- FDA classified
- 17 Jul 2014
- Reported
- 23 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 3 Jul 2014 | Recall initiated by company | |
| 17 Jul 2014 | Classified by FDA | +14 days |
| 23 Jul 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
Where it was distributed
Nationwide, Puerto Rico, and Guam.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Which lots are affected?
Lot #: 3045659, 3048256, Exp 07/14
Where was it sold?
Nationwide, Puerto Rico, and Guam.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Diltiazem recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules 12HR recalledDiltiazem Hydrochloride | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg recalledDiltiazem Hydrochloride | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules recalled | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem Hydrochloride | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules recalled | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |