FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nutricia North America
- Product
- TYR Anamix Early Years infant formula Net Wt. 14.1 oz (400g)…
- Reason
- Infant formula contains undeclared tyrosine
- Published
- June 28, 2023
- Distribution
- Alaska, California, Connecticut, Florida…
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FDA Recall
Terminated
Historical recordClass II
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
- Published
- June 21, 2023
- Distribution
- LA, PA and OH.
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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
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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
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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
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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
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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
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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
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Van Leeuwen Ice Cream LLC
- Product
- Van Leeuwen brand BROWN SUGAR CHUNK WITH COOKIE DOUGH & BROW…
- Reason
- Product may contain undeclared walnuts.
- Published
- June 21, 2023
- Distribution
- Multiple states
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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
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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
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Werner Gourmet Meat Snacks, Inc.
- Product
- Chili Cacahuate Japones, net weight 5 oz (127g), packaged in…
- Reason
- Undeclared peanut
- Published
- June 14, 2023
- Distribution
- distributed in CA, CO, FL, GA, MD, NJ, N…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Meijer Inc
- Product
- Meijer Express Dark Chocolate Covered Almonds, 7.5oz plastic…
- Reason
- undeclared milk
- Published
- June 14, 2023
- Distribution
- The recall includes stand-up pouches car…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Meijer Inc
- Product
- Frederik's by Meijer Dark Chocolate Almonds, 12oz stand-up p…
- Reason
- undeclared milk
- Published
- June 14, 2023
- Distribution
- The recall includes stand-up pouches car…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gonnella Frozen Products, LLC
- Product
- Brat Roll Frozen Dough Product Code 18429 UPC: 0007829618429…
- Reason
- Undeclared egg
- Published
- June 14, 2023
- Distribution
- Distributed to distributors in MI, MN, O…
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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 →
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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