CLASS III Drug recall · Reported 2 May 2018 · FDA Enforcement Report
Diltiazem HCl Extended-Release Capsules, USP 240 mg recalled
Mckesson Packaging Services is recalling Diltiazem HCl Extended-Release Capsules, USP 240 mg, distributed nationwide in the US. The recall was initiated on 23 Apr 2018 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-0716-2018
- FDA event ID
- 79936
- Recalling firm
- Mckesson Packaging Services, Concord, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Apr 2018
- FDA classified
- 7 May 2018
- Reported
- 2 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 23 Apr 2018 | Recall initiated by company | |
| 2 May 2018 | Published in enforcement report | +9 days |
| 7 May 2018 | Classified by FDA | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications. High dissolution results were obtained during 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 240 mg, 100-count bottles, Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-016-10
Where it was distributed
Nationwide with the US
Questions about this recall
Is Diltiazem HCl Extended-Release Capsules, USP 240 mg recalled?
Yes. Mckesson Packaging Services recalled Diltiazem HCl Extended-Release Capsules, USP 240 mg on 23 Apr 2018. The recall is Class III and its status is Terminated. Recall number D-0716-2018.
Why was it recalled?
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Which lots are affected?
Lot #: 0115087, Exp. 12/2018
Where was it sold?
Nationwide with the US
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 21 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 Mckesson Packaging Services
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Diltiazem HCl Extended-Release Capsules, USP 120 mg recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Diltiazem CD (Diltiazem Hydrochloride Extended-Release recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Ranitidine Tablets, USP 150 mg UD recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Megestrol Acetate Oral Suspension, USP 400 mg/ UD cups in boxes recalled | Mckesson Packaging Services | Potency & Assay | Nationwide |
| Drug | CLASS III | Propafenone Hydrochloride tablets, 150 mg recalled | Mckesson Packaging Services | Potency & Assay | 5 states |
Other Diltiazem recalls
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules 12HR recalledDiltiazem Hydrochloride | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg recalledDiltiazem Hydrochloride | Glenmark Pharmaceuticals Inc., U | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules recalled | Glenmark Pharmaceuticals Inc., U | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem Hydrochloride | Glenmark Pharmaceuticals Inc., U | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules recalled | Glenmark Pharmaceuticals Inc., U | Nitrosamine Impurity | Nationwide |