FDA Recall
TerminatedTerminated: June 20, 2023Historical recordClass I
IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.
by Teva Pharmaceuticals USA Inc
- Reason
- Presence of Particulate Matter: Product was found to contain silica and iron oxide
- Published
- April 20, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 14, 2024Historical recordClass II
Wilton Industries Inc
- Product
- Wilton Ready to Build Chocolate Cookie Bunny Hutch Kit, UPC:…
- Reason
- Milk is missing from the product's allergen Contains statement
- Published
- April 20, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 11, 2022Historical recordClass II
Ittella International, LLC
- Product
- Tattooed Chef Plant-Based Sausage Breakfast Bowl Frozen 18…
- Reason
- A gluten free claim was inadvertently used on the lid of the container. However, the ingredient statement declares enriched wheat flour as an ingredient and the allergen information statement disclosed the presence of EGGS, WHEAT, MILK, SOY, COCONUT, in bolded text.
- Published
- April 20, 2022
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2023Historical recordClass II
Continental Mills (Corporate Office)
- Product
- Item # 744-4930, Gordon Choice Southern Style Fish Breader.…
- Reason
- foreign materials
- Published
- April 20, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2023Historical recordClass II
Continental Mills (Corporate Office)
- Product
- Item # 744-4875, Gordon Choice Yellow Cake Mix. Product is…
- Reason
- foreign materials
- Published
- April 20, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2023Historical recordClass II
Continental Mills (Corporate Office)
- Product
- Item # 722-0105, Krusteaz Cinnamon Crumb Cake. Product is s…
- Reason
- foreign materials
- Published
- April 20, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2023Historical recordClass II
Continental Mills (Corporate Office)
- Product
- Item # 721-1000, Krusteaz Belgian Waffle Mix. Product is sh…
- Reason
- foreign materials
- Published
- April 20, 2022
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2023Historical recordClass II
Continental Mills (Corporate Office)
- Product
- Item # 743-0278, IHOP Pancake. Product is shelf stable and…
- Reason
- foreign materials
- Published
- April 20, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2023Historical recordClass II
Continental Mills (Corporate Office)
- Product
- Item # 731-0120, Krusteaz Pro Buttermilk Pancake Mix. Produ…
- Reason
- foreign materials
- Published
- April 20, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2023Historical recordClass II
Continental Mills (Corporate Office)
- Product
- Item # 721-0200, Krusteaz Buttermilk Pancake Mix. Product i…
- Reason
- foreign materials
- Published
- April 20, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2023Historical recordClass II
Continental Mills (Corporate Office)
- Product
- Item # 714-5000, Great Value Buttermilk Pancake & Waffle Mix…
- Reason
- foreign materials
- Published
- April 20, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2023Historical recordClass II
Continental Mills (Corporate Office)
- Product
- Item # 714-0706, Kroger Buttermilk Pancake & Waffle Mix. Pr…
- Reason
- foreign materials
- Published
- April 20, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 21, 2023Historical recordClass III
Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 8, 2023Historical recordClass I
SYMJEPI (epinephrine injection, USP) 0.15 mg (0.15 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-131-02.
by Adamis Pharmaceuticals Corporation
- Reason
- Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 8, 2023Historical recordClass I
SYMJEPI (epinephrine injection, USP) 0.3 mg, (0.3 mg/0.3 mL), Two Pre-Filled Single-Dose Syringes per carton, Rx Only, Manufactured for Adamis Pharmaceuticals Corp.; San Diego, CA 92130; Distributed by USWM, LLC., Louisville, KY 40241, Made in Belgium, NDC 78670-130-02
by Adamis Pharmaceuticals Corporation
- Reason
- Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 29, 2023Historical recordClass III
Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07.
by Macleods Pharma Usa Inc
- Reason
- FAILED CONTENT UNIFORMITY SPECIFICATIONS
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 28, 2024Historical recordClass II
Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 .
by Pfizer Inc.
- Reason
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 28, 2024Historical recordClass II
quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0223-1
by Pfizer Inc.
- Reason
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 28, 2024Historical recordClass II
quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-0220-1
by Pfizer Inc.
- Reason
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Published
- April 13, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 28, 2024Historical recordClass II
quinapril and hydrochlorothiazide tablets, 20 mg/25 mg*, 90 Tablets bottles, Rx Only, Distributed by: Greenstone, LLC, Peapack, NJ, 07977, Made in Germany, NDC 59762-5225-9
by Pfizer Inc.
- Reason
- CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.
- Published
- April 13, 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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