CLASS III ONGOING Drug recall · Reported 17 Jul 2024 · FDA Enforcement Report
Verapamil Hydrochloride Injection, USP 5 mg /(2.5 mg/mL) recalled
Zydus Pharmaceuticals is recalling Verapamil Hydrochloride Injection, USP 5 mg /(2.5 mg/mL), packaged as (a) mL Single-Dose, distributed nationwide in the US. The recall was initiated on 2 Jul 2024 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-0592-2024
- FDA event ID
- 94912
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 2 Jul 2024
- FDA classified
- 10 Jul 2024
- Reported
- 17 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 2 Jul 2024 | Recall initiated by company | |
| 10 Jul 2024 | Classified by FDA | +8 days |
| 17 Jul 2024 | 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
Cross contamination with other products.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534,
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Cross contamination with other products.
Which lots are affected?
Lot# (a) Lots L300255, L300262, Exp Date 07/31/2025; (b)L300263, Exp Date 08/31/2025
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 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.
Other products in this recall event
1 other product · FDA event 94912| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Verapamil Hydrochloride Injection, USP 10 mg/ (2.5 mg/mL) recalledVerapamil Hydrochloride | Zydus Pharmaceuticals | Other | Nationwide |
More recalls from Zydus Pharmaceuticals
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals | Potency & Assay | 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 II | Verapamil Hydrochloride Extended-Release Tablets recalled | Amerisource Health Services | Potency & Assay | Nationwide |
| Drug | CLASS II | Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg 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 |