FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Abbott Laboratories
- Product
- Similac 360 Total Care/Similac 360 Total Care Sensitive Disc…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Abbott Laboratories
- Product
- Similac 360 Total Care 2 fl oz reclose able plastic bottle…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Abbott Laboratories
- Product
- Pedialyte Unflavored (Export to Canada) 2 fl oz plastic recl…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Abbott Laboratories
- Product
- Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic r…
- Reason
- Compromised seal integrity which could lead to spoilage
- Published
- November 23, 2022
- Distribution
- Domestic: Alaska, Alabama, Arizona, Cali…
View recall →
FDA Recall
Terminated
Historical recordClass I
Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton).
by Viatris Inc
- Reason
- Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
- Published
- November 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hammond's Candies Since 1920 II, LLC
- Product
- Hammond's Salted Caramel Cookies, NET WT. 5 OZ (142g), UPC 6…
- Reason
- Peanut Butter Chocolate Chip Cookies mispacked in Salted Caramel Cookies Box creating undeclared peanut allergen.
- Published
- November 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990.
by Genentech Inc
- Reason
- Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
- Published
- November 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Presence of Foreign Substance
- Published
- November 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
by Exela Pharma Sciences LLC
- Reason
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1
by Exela Pharma Sciences LLC
- Reason
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10
by Golden State Medical Supply Inc.
- Reason
- Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01
by VistaPharm, Inc.
- Reason
- cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.
by Ultra Chem Labs Corp
- Reason
- Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.
by Ultra Chem Labs Corp
- Reason
- Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe)
by AuroMedics Pharma LLC
- Reason
- Subpotent Drug: Out of specification for assay
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Secrets Of The Tribe
- Product
- Indian Gooseberry Alcohol-Free Extract, 2 oz. glass bottle,…
- Reason
- Product has elevated level of lead.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Secrets Of The Tribe
- Product
- Amla Alcohol-Free Extract, 2 oz. glass bottle, UPC 041979376…
- Reason
- Product has elevated level of lead.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
- Published
- October 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com
by LNK International, Inc.
- Reason
- Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
- Published
- October 26, 2022
- 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.
Read the full medical disclaimer.