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Latest U.S. Recalls

Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.

7,817published records in database

4recall categories represented

Jun 7, 2023newest stored source record

Latest records

Latest recalls — page 276

The newest recall records with useful source details are listed here.

DrugJun 7, 2023

SSM Health Care St. Louis DBA SSM St. Clare HYDROmorphone HCl 10 mg in 0.9% Sodium recall — FDA D-0776-2023

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or…

Class IIFDA: OngoingSSM Health Care St. Louis DBA SSM St. Clare Health…

DrugJun 7, 2023

Akorn Lactulose Solution, USP recall — FDA D-0815-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Olopatadine HCl Ophthalmic Solution, USP, 0.1%, 5 mL bottles recall — FDA D-0833-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles recall — FDA D-0826-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL recall — FDA D-0848-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles recall — FDA D-0810-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg) recall — FDA D-0807-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or recall — FDA D-0809-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one packaged tray recall — FDA D-0791-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Sodium Chloride Ophthalmic Solution, USP, 5%, 50mg/mL, 15 mL bottles recall — FDA D-0845-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes recall — FDA D-0824-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL recall — FDA D-0780-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Apraclonidine Ophthalmic Solution 0.5% recall — FDA D-0784-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free recall — FDA D-0808-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Tobramycin Inhalation Solution USP, 300 mg/5 mL, 4 single-dose ampules recall — FDA D-0850-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Valproic Acid Oral Solution, USP, 250mg/5mL, 473 mL bottles recall — FDA D-0854-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Prednisolone Oral Solution, USP, 15 mg/5 mL recall — FDA D-0836-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL (10 mg/mL) ampules, 2 mL ampules recall — FDA D-0799-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Levofloxacin Oral Solution, 25 mg/mL recall — FDA D-0819-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Pilocarpine Hydrochloride Ophthalmic Solution, USP 2%, 15 mL bottles recall — FDA D-0861-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Amantadine Hydrochloride Oral Solution USP, 50mg/5mL, 473mL bottles recall — FDA D-0857-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn IC-Green recall — FDA D-0812-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles recall — FDA D-0797-2023

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

Class IIFDA: OngoingAkorn, Inc.

DrugJun 7, 2023

Akorn Naloxone Injection, USP 0.4 mg/mL, For Intravenous, Intramuscular or Subcutaneous Use recall — FDA D-0830-2023

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

Class IIFDA: OngoingAkorn, Inc.

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August 2026149 records · 4 categories July 2026371 records · 4 categories June 2026375 records · 4 categories May 2026340 records · 4 categories April 2026415 records · 4 categories March 2026190 records · 4 categories February 2026331 records · 4 categories January 2026212 records · 4 categories December 2025389 records · 4 categories November 2025326 records · 4 categories October 2025455 records · 4 categories September 2025285 records · 4 categories