Class III · Low risk
Verapamil Hydrochloride Injection
Cross contamination with other products.
Verapamil Hydrochloride Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Cross contamination with other products.
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534, Vial NDC: 70710-1644-1, Carton NDC: 70710-1644-5.
Affected NDCs
70710-1644-01
70710-1644-05
Compare with the code on your package — it is the most precise check available.
Drug: Verapamil
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Verapamil Hydrochloride NDC 70710-1644 |
2.5 mg/mL | Injection, Solution Intravenous |
Zydus Pharmaceuticals USA Inc. | Rx |
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0593-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Verapamil recalls
See all
Class III · Low risk
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg
Subpotent: Out of Specification for Assay Test at the 3-month time point.
Class II · Moderate risk
Verapamil Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Class II · Moderate risk
Verapamil Hydrochloride Extended-Release Tablets
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Class II · Moderate risk
Verapamil HCL
cGMP deviations: Temperature abuse
Other recalls by Zydus Pharmaceuticals (USA) Inc
All 2024 recalls
Class II · Moderate risk
Mirabegron Extended-Release Tablets
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk
Erythromycin Tablets
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Class II · Moderate risk
Icosapent Ethyl Capsules
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
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