HIGHFDA DRUG

Dr. Reddy's Succinylcholine Chloride Injection Recall 2025 — 571 Vials Over OOS Preservative Drop

Dr. Reddy's Laboratories Inc. recalled 571 vials of Succinylcholine Chloride Injection, USP nationwide in the United States. The recall cites an out-of-specification result during six-month stability testing due to decreased preservative concentration. Healthcare providers and patients should stop using the product immediately and await guidance from the recall letter.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
September 26, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
September 26, 2025
Hazard Level
HIGH
Brands
Succinylcholine, Dr. Reddy's Laboratories
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Succinylcholine, Dr. Reddy's Laboratories
Product type
Injectable medication
Model numbers
K250048
UPC codes
43598-666, 43598-666-11, 43598-666-25
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    September 26, 2025

  2. Reported by FDA DRUG

    October 15, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Dr. Reddy's Laboratories, Inc. or your healthcare provider for guidance. Notification method: Letter

About This Product

Succinylcholine Chloride Injection is a short-acting neuromuscular blocker used to facilitate intubation and muscle relaxation during surgery. The product is distributed in multi-dose vials for hospital and clinical use.

Why This Is Dangerous

The product showed an out-of-specification result in six-month stability testing, specifically a decrease in preservative concentration. This can raise concerns about sterility and potency of the injectable medication.

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

Hospitals and surgical teams may need to identify alternative neuromuscular blocking agents and adjust procurement to replace the recalled lots.

Practical Guidance

How to identify if yours is affected

  1. Check NDC 43598-666-25 on the vial label.
  2. Verify Lot number K250048 on the packaging.
  3. Confirm quantity on hand is 571 vials.

Where to find product info

Recall letters and identification details are available via the FDA recall page linked in the notice.

What timeline to expect

Replacement or discard instructions will be provided in the recall letter; typical recall timelines include weeks to months depending on facility.

If the manufacturer is unresponsive

  • Escalate to hospital risk management or the medical affairs liaison for Dr. Reddy's Laboratories.
  • Contact the FDA recall enforcement line if the company is unresponsive.

How to prevent similar issues

  • Implement strict lot-level quarantine procedures for all recalled products.
  • Verify NDC and lot numbers during receiving to prevent mix-ups with non-recalled lots.
  • Maintain an updated recall contact list for vendors and suppliers.

Documentation advice

Keep the recall letter, FDA notice, and correspondence with the distributor. Photograph and log the recalled lot and its disposition.

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Product Details

NDC 43598-666-25. Lot K250048. 25 x 10 mL multiple-dose vials. 200 mg/10 mL (20 mg/mL). For intravenous or intramuscular use. Rx Only. Distributed nationwide by Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 6-month stability testing with out-of-specification result
  • Distributor: Dr. Reddy's Laboratories Inc.
  • Nationwide distribution in the USA

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
POISONINGLACERATIONELECTRICALOTHER

Product Classification

Product Details

Model Numbers
K250048
UPC Codes
43598-666
43598-666-11
43598-666-25
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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