CLASS III Drug recall · Reported 30 Nov 2016 · FDA Enforcement Report
Diltiazem HCl Extended-release Capsules, USP 120 mg bottle recalled
Mylan Pharmaceuticals is recalling Diltiazem HCl Extended-release Capsules, USP 120 mg bottle (, distributed nationwide in the US. The recall was initiated on 3 Nov 2016 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-0151-2017
- FDA event ID
- 75634
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Nov 2016
- FDA classified
- 23 Nov 2016
- Reported
- 30 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 3 Nov 2016 | Recall initiated by company | |
| 23 Nov 2016 | Classified by FDA | +20 days |
| 30 Nov 2016 | Published in enforcement report | +7 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: OOS results for known compound.
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, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: OOS results for known compound.
Which lots are affected?
0378-5220-01 Lot# 3065133; Exp. 03/17 0378-5220-01 Lot# 3066564; Exp. 05/17 0378-5220-05 Lot# 3066564; Exp. 05/17 0378-5220-01 Lot# 3069645; Exp. 08/17 0378-5220-05 Lot# 3069645; Exp. 08/17
Where was it sold?
Nationwide
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 Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
Other Diltiazem recalls
All 39| 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 |