Levetiracetam in 0 — Class I drug recall D-0485-2019

Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2019-02-20, distributed nationwide. Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incor

Recall number	`D-0485-2019`
Product type	Drug
Classification	Class I
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States
Recall initiated	2018-10-26
Classified	2019-02-11
Reported by FDA	2019-02-20
Terminated	2023-04-04
Distributed	Nationwide (US)
Reason classes	labeling, potency
UPC / GTIN / UDI-DI	`00343598637525`
NDC	`43598-0635`, `43598-0635-10`, `43598-0635-52`, `43598-0636`, `43598-0636-10`, `43598-0636-52`, `43598-0637`, `43598-0637-10`, `43598-0637-52`
Expiration dates	`2020-05`

Product

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).

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0485-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.