Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infus...

FDA Drug Recall #D-0485-2019 — Class I — October 26, 2018

Recall Summary

Recall Number D-0485-2019
Classification Class I — Serious risk
Date Initiated October 26, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Dr. Reddy's Laboratories, Inc.
Location Princeton, NJ
Product Type Drugs
Quantity 2770 bags; 277 selling units

Product Description

Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 UPC 343598637525 ---- NDC 43598-637-52

Reason for Recall

Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).

Distribution Pattern

Nationwide

Lot / Code Information

ABD807, exp 05/2020

Other Recalls from Dr. Reddy's Laboratories, Inc.

Recall # Classification Product Date
D-0219-2026 Class III Varenicline Tablets, 1mg, 56 Tablets, Rx only, ... Nov 11, 2025
D-0008-2026 Class II Succinylcholine Chloride Injection, USP, 200 mg... Sep 26, 2025
D-0525-2025 Class II Omeprazole Delayed-release Capsules, USP, 20mg,... Jun 30, 2025
D-0365-2025 Class I Levetiracetam 0.75% in Sodium Chloride Injectio... Mar 13, 2025
D-0117-2025 Class III Javygtor (sapropterin dihydrochloride) Tablets ... Nov 22, 2024

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.