Medications & Supplements/Prescription Drugs

Verapamil Hydrochloride Injection Recalled for Cross-Contamination Risk

Agency Publication Date: July 10, 2024

Summary

Zydus Pharmaceuticals (USA) Inc. has recalled 178,775 vials of Verapamil Hydrochloride Injection, USP (2.5 mg/mL) because the products may be contaminated with other drug products. Verapamil Hydrochloride is an injectable medication used to manage high blood pressure, chest pain, and certain heart rhythm disorders. This voluntary recall affects both 5 mg/2mL and 10 mg/4mL single-dose vials distributed nationwide.

Risk

The injection vials may contain traces of other medications due to cross-contamination during the manufacturing process. This poses a risk of unintended pharmacological effects or allergic reactions, though the health risk is currently classified as low.

What You Should Do

This recall affects Verapamil Hydrochloride Injection, USP (2.5 mg/mL) sold in 5 mg/2mL and 10 mg/4mL vials under the Zydus Pharmaceuticals (USA) Inc. brand.
Identify the affected products by checking the NDC codes on the vial or carton: 70710-1643-1, 70710-1643-7, 70710-1643-5, 70710-1644-1, or 70710-1644-5.
Check the lot numbers printed on the packaging: L300255 (Exp 07/31/2025), L300262 (Exp 07/31/2025), L300263 (Exp 08/31/2025), or L300269 (Exp 07/31/2025).
Stop using the recalled product. Contact Zydus Pharmaceuticals (USA) Inc. or your distributor to arrange for the return of all affected vials.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance or visit www.fda.gov/safety/recalls.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Verapamil Hydrochloride Injection, USP 5 mg / 2mL (2.5 mg/mL)

Variants: 5 mg / 2mL, 2.5 mg/mL, 25x2 mL Single-Dose Vial per carton, 5x2 mL Single-Dose Vial per carton

Lot Numbers:

L300255 (Exp 07/31/2025)

L300262 (Exp 07/31/2025)

L300263 (Exp 08/31/2025)

NDC:

70710-1643-1

70710-1643-7

70710-1643-5

Quantity: 170,755 vials

Product: Verapamil Hydrochloride Injection, USP 10 mg / 4 mL (2.5 mg/mL)

Variants: 10 mg / 4 mL, 2.5 mg/mL, 5 x 4 mL Single-Dose Vial per carton

Lot Numbers:

L300269 (Exp 07/31/2025)

NDC:

70710-1644-1

70710-1644-5

Quantity: 8,020 vials

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94912

Status: Active

Manufacturer: Zydus Pharmaceuticals (USA) Inc

Sold By: Hospitals; Surgical Centers; Wholesalers; Distributors

Manufactured In: India, United States

Units Affected: 2 products (170,755 vials; 8020 vials)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Verapamil Hydrochloride Injection, USP (2.5 mg/mL) sold in 5 mg/2mL and 10 mg/4mL vials under the Zydus Pharmaceuticals (USA) Inc. brand.

Identify the affected products by checking the NDC codes on the vial or carton: 70710-1643-1, 70710-1643-7, 70710-1643-5, 70710-1644-1, or 70710-1644-5.

Check the lot numbers printed on the packaging: L300255 (Exp 07/31/2025), L300262 (Exp 07/31/2025), L300263 (Exp 08/31/2025), or L300269 (Exp 07/31/2025).

Stop using the recalled product. Contact Zydus Pharmaceuticals (USA) Inc. or your distributor to arrange for the return of all affected vials.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance or visit www.fda.gov/safety/recalls.

Affected Products

Product: Verapamil Hydrochloride Injection, USP 5 mg / 2mL (2.5 mg/mL)

Variants: 5 mg / 2mL, 2.5 mg/mL, 25x2 mL Single-Dose Vial per carton, 5x2 mL Single-Dose Vial per carton

Lot Numbers:

L300255 (Exp 07/31/2025)

L300262 (Exp 07/31/2025)

L300263 (Exp 08/31/2025)

NDC:

70710-1643-1

70710-1643-7

70710-1643-5

Quantity: 170,755 vials

Product: Verapamil Hydrochloride Injection, USP 10 mg / 4 mL (2.5 mg/mL)

Variants: 10 mg / 4 mL, 2.5 mg/mL, 5 x 4 mL Single-Dose Vial per carton

Lot Numbers:

L300269 (Exp 07/31/2025)

NDC:

70710-1644-1

70710-1644-5

Quantity: 8,020 vials