Dr. Reddy's Recalls Levetiracetam Injection Due to Labeling Error
Dr. Reddy's Laboratories is recalling Levetiracetam Injection bags because the primary label incorrectly identifies the product strength and sodium chloride concentration.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric, as Class I recalls involve a reasonable probability that the use of the product will cause serious adverse health consequences or death.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL) for intravenous infusion. The recall involves 2,770 bags (2,770 selling units) with lot number ABD807 and an expiration date of 05/2020. The product was distributed nationwide.
The recall was initiated due to a labeling error on the primary infusion bag and the National Drug Code (NDC). The pre-printed text incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL), whereas the external foil pouch correctly identifies it as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL). This discrepancy creates a risk of medication error if the primary label is relied upon for administration.
Healthcare providers and patients should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be quarantined and not administered. The recalling firm, Dr. Reddy's Laboratories, Inc., is responsible for the recall.
The recalled product
- Product
- LEVETIRACETAM (LEVETIRACETAM INJECTION)
- Brand
- LEVETIRACETAM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- ABD807
- exp 05/2020
UPCs (1)
- 343598637525
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LEVETIRACETAM
- SevereLevetiracetam Injection Label Mismatch Nationwide Recall
FDA (Drugs) · 2025-04-23
- ModerateAurobindo Recalls Levetiracetam Tablets Due to Manufacturing Water Leakage
FDA (Drugs) · 2020-04-22
- SevereAuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns
FDA (Drugs) · 2018-05-09
- SevereAuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns
FDA (Drugs) · 2018-05-09
- SevereAuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns
FDA (Drugs) · 2018-05-09
Same manufacturer · Dr. Reddy's Laboratories, Inc.
See all →- ModerateVarenicline tablets recalled after an assay value fell below specification
FDA (Drugs) · 2025-12-17
- Moderate
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23
- ModerateFDA Recalls JAVYGTOR Tablets Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2024-12-18
- LowIbuprofen 600 mg tablets recalled for failed tablet specifications
FDA (Drugs) · 2024-11-27
Same hazard · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02