Accord Healthcare, Inc.

FDA Regulatory Profile

Accord Healthcare, Inc. appears in FDA public data with 106 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0777-2026, Class II) was initiated on August 6, 2026.

Summary

Total Recalls
106 (2 Class I)
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Known Names

accord healthcare, accord healthcare, inc

Recent Recalls

NumberClassProductDate
D-0777-2026Class IILevothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for:August 6, 2026
D-0781-2026Class IILevothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured forAugust 6, 2026
D-0784-2026Class IILevothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-45August 6, 2026
D-0775-2026Class IILevothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for:August 6, 2026
D-0776-2026Class IILevothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: August 6, 2026
D-0785-2026Class IILevothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457August 6, 2026
D-0783-2026Class IILevothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for:August 6, 2026
D-0782-2026Class IILevothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-45August 6, 2026
D-0780-2026Class IILevothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured forAugust 6, 2026
D-0779-2026Class IILevothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-August 6, 2026
D-0786-2026Class IILevothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: AcAugust 6, 2026
D-0778-2026Class IILevothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for:August 6, 2026
D-0656-2026Class IILevothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: AJune 8, 2026
D-0006-2026Class IILevothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured fSeptember 16, 2025
D-0522-2025Class IILevothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for:June 20, 2025
D-0521-2025Class IILevothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: AJune 20, 2025
D-0518-2025Class IILevothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: AcJune 20, 2025
D-0524-2025Class IILevothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for:June 20, 2025
D-0520-2025Class IILevothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: AccJune 20, 2025
D-0523-2025Class IILevothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: June 20, 2025