US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 2, 2013 (13 years ago)

Ferrous Sulfate

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W002711, EXP: 6/6/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W002825, EXP: 12/31/2013; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60236_1, EXP: 5/22/2014.

What was recalled

FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904759160

Recalling firm
Aidapak Services, LLC
Origin
WA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-489-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Ferrous recalls

See all
Class II · Moderate risk Ongoing

Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe

Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Safecor Health, LLC D-0252-2025
Class II · Moderate risk Ongoing

Ferrous Sulfate Iron Supplement Drops

Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc. D-0803-2023
Class II · Moderate risk Terminated

Ferrous Sulfate 75 mg

Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Cardinal Health Inc. NDC 54838-011-50 D-0504-2021
Class II · Moderate risk Terminated

Mibelas 24 Fe

Reason Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.

Lupin Pharmaceuticals Inc. D-1502-2020
Class II · Moderate risk Terminated

Blisovi Fe 1.5/30

Reason Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.

Lupin Pharmaceuticals Inc. NDC 68180-866-11 D-0638-2020