Home / Recalls / Exela Pharma Sciences LLC / D-0826-2018

D-0826-2018 Class II Terminated

Recalled by Exela Pharma Sciences LLC — Lenoir, NC

FDA drug recall D-0826-2018 was initiated by Exela Pharma Sciences LLC on Apr 20, 2018 and is designated Class II. Reason for recall: Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets. The recall status is terminated (terminated Jun 4, 2020). Affected quantity: 5256 bottles.

Recall Details

Product Type: Drugs
Report Date: May 30, 2018
Initiation Date: Apr 20, 2018
Termination Date: Jun 4, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5256 bottles

Product Description

Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.

Reason for Recall

Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

Lot: GH70154, Exp 12/18

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0826-2018
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Exela Pharma Sciences LLC

D-0620-2025 Class II — 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For… (Jul 30, 2025)
D-0303-2025 Class II — 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL… (Mar 7, 2025)
D-0116-2024 Class I — 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL… (Oct 18, 2023)
D-0118-2024 Class I — ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL… (Oct 18, 2023)
D-0117-2024 Class I — Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL… (Oct 18, 2023)
D-0079-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose… (Nov 28, 2022)
D-0080-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose… (Nov 28, 2022)
D-0022-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose… (Oct 4, 2022)
D-0023-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose… (Oct 4, 2022)
D-0369-2022 Class II — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx… (Jan 11, 2022)