FDA Recall
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac Water - Sterilized (Export Canada) 2 fl oz reclose…
- 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
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose…
- 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
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac Stage 1 (Export Colombia) 2 fl oz reclose able plast…
- 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
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac Special Care 2 fl oz reclose able plastic bottle Pa…
- 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
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac Total Comfort 2 fl oz reclose able plastic bottle P…
- 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
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac Neosure 2 fl oz reclose able plastic bottle Package…
- 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
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac 360 Total Care Sensitive with Nipples 2 fl oz reclos…
- 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
TerminatedTerminated: August 14, 2024Historical recordClass II
Abbott Laboratories
- Product
- Similac 360 Total Care Sensitive 2 fl oz reclose able plasti…
- 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
TerminatedTerminated: August 14, 2024Historical 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
TerminatedTerminated: August 14, 2024Historical 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
TerminatedTerminated: August 14, 2024Historical 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
TerminatedTerminated: August 14, 2024Historical 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
TerminatedTerminated: January 12, 2024Historical 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
TerminatedTerminated: January 11, 2024Historical 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
TerminatedTerminated: April 17, 2024Historical 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
TerminatedTerminated: September 7, 2023Historical 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
TerminatedTerminated: October 10, 2025Historical 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
TerminatedTerminated: October 10, 2025Historical 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
CompletedHistorical 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
TerminatedTerminated: March 20, 2025Historical 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 →
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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