Class III · Low risk Ongoing
busPIRone Hydrochloride Tablets
Reason Subpotent drug
Ferrous Sulfate Iron Supplement Drops
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
What was recalled
Ferrous Sulfate Iron Supplement Drops, packaged in 50 mL bottles, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Recalling firm
- Akorn, Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0803-2023
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 Iron recalls
See all
Class II · Moderate risk Ongoing
Spironolactone Tablets
Reason Presence of foreign substance: identified as aluminum.
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.
Class II · Moderate risk Ongoing
Venofer
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk Ongoing
Venofer
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
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