CLASS II Drug recall · Reported 15 Mar 2023 · FDA Enforcement Report
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg recalled
Amerisource Health Services is recalling Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, distributed nationwide in the US. The recall was initiated on 27 Jan 2023 and the FDA has classified it as Class II.
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-0436-2023
- FDA event ID
- 91670
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jan 2023
- FDA classified
- 6 Mar 2023
- Reported
- 15 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 27 Jan 2023 | Recall initiated by company | |
| 6 Mar 2023 | Classified by FDA | +38 days |
| 15 Mar 2023 | Published in enforcement report | +9 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 Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
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
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Which lots are affected?
Lot 1009065, Exp 12/31/2023
Where was it sold?
Nationwide in the USA
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Amerisource Health Services
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
Other Verapamil recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Verapamil Hydrochloride Injection, USP 10 mg/ (2.5 mg/mL) recalledVerapamil Hydrochloride | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Verapamil Hydrochloride Injection, USP 5 mg /(2.5 mg/mL) recalledVerapamil Hydrochloride | Zydus Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Verapamil Hydrochloride Extended-Release Tablets recalled | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Verapamil HCL, ampule, 2.5 mg/ML recalled by Mckesson Medical-Surgical | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Verapamil Hydrochloride Extended-Release Tablets USP 120 mg recalledVerapamil Hydrochloride | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |