FDA Recall
Ongoing
Historical recordClass III
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
by AVKARE LLC
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Published
- June 21, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon / 3785.41ml, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
by Jarman's Midwest Cleaning Systems, Inc.
- Reason
- Chemical Contamination: FDA testing found Presence of methanol
- Published
- June 21, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013.
by Jarman's Midwest Cleaning Systems, Inc.
- Reason
- Chemical Contamination: FDA testing found Presence of methanol
- Published
- June 21, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01
by Jarman's Midwest Cleaning Systems, Inc.
- Reason
- CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.
- Published
- June 21, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30
by Amring Pharmaceuticals Inc
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Published
- June 21, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
HU PRODUCTS
- Product
- Hu Vanilla Crunch Dark Chocolate bar
- Reason
- may contain undeclared tree-nuts
- Published
- June 21, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations
- Published
- June 14, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottle), b) NDC 51407-731-05 (5 mL bottle).
by Golden State Medical Supply Inc.
- Reason
- Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.
- Published
- June 14, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1
by Empower Clinic Services LLC dba Empower Pharmacy
- Reason
- Mislabeling: preservative free product labeled as preserved.
- Published
- June 14, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Pilocarpine Hydrochloride Ophthalmic Solution, USP 4%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate, 1.25mg/3mL, 0.5 mL unit-dose vials, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Vitamin D Supplement Drops, 400 IU, Cherry Flavored 50mL bottle, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Tropicamide Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Trihexyphenidyl Hydrochloride Oral Solution, USP, 2mg/5mL, 473 mL bottles, Rx only, Distributed by: VersaPharm, Inc. - An Akorn Company- Lake Forest, IL 60045. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx only, Manufactured by: Akorn , Inc, Lake Forest, IL 60045. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL, 473 mL bottles, Cherry Flavor, Rx only, Manufactured by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL, packaged in a)1 mL ampules, b) 2mL ampules, c) 5mL ampules, For Intravenous and Epidural Use, Rx only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Sodium DIURIL (chlorothiazide sodium), 0.5g/vial, Single-dose vial Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
by Akorn, Inc.
- Reason
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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