FoodAug 25, 2021
Cocanu Moonwalk 70% dark chocolate bar recall — FDA F-0867-2021
Lactose is declared but milk is not declared on label.
Class IIFDA: TerminatedCocanu LLC
August 2021 recalls — page 3
These records include useful source details for the selected month.
FoodAug 25, 2021
Able Groupe HiPP German Stage 1 Combiotic Infant Milk Formula recall — FDA F-0914-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not…
Class IFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe Holle Bio Stage PRE Organic Infant Milk Formula recall — FDA F-0917-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not…
Class IFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe HiPP UK Stage 2 Combiotic Follow-On Infant Milk Formula recall — FDA F-0925-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear…
Class IIFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe Holle Bio Stage 1 Organic Infant Milk Formula recall — FDA F-0916-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not…
Class IFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe HiPP HA Germany Hypoallergenic Stage 2 Combiotic Follow-On recall — FDA F-0913-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear…
Class IIFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe Holle Goat Stage 2 Organic Follow-On Infant Milk Formula recall — FDA F-0920-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear…
Class IIFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe Kendamil Organic Stage 2 Follow on Milk Formula recall — FDA F-0927-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear…
Class IIFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe Holle Bio Stage 2 Organic Follow-On Infant Milk Formula recall — FDA F-0918-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear…
Class IIFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe Lebenswert Folgemilch Stage 3 Organic Toddler Formula recall — FDA F-0923-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear…
Class IIFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe HiPP Dutch Stage 2 Combiotic Follow-on Milk Formula recall — FDA F-0911-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear…
Class IIFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk recall — FDA F-0910-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not…
Class IFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe HiPP Comfort Milk Formula recall — FDA F-0907-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not…
Class IFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe Holle Goat Stage 1 Organic Infant Milk Formula recall — FDA F-0919-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear…
Class IIFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe HiPP HA Germany Hypoallergenic Stage 1 Combiotic Infant Milk recall — FDA F-0912-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. All products are not labeled as required by 21 CFR 107 .10 and 107.20 and do not bear…
Class IIFDA: TerminatedAble Groupe Inc.
FoodAug 25, 2021
Able Groupe Lebenswert Anfangsmilch Stage 1 Organic Infant Milk Formula recall — FDA F-0921-2021
The required pre-market notifications for these new infant formulas have not been submitted to the FDA. Some products contain less than 1 milligram of iron per 100 Calories and may not…
Class IFDA: TerminatedAble Groupe Inc.
DrugAug 25, 2021
High Performance Formulas Cholestene capsules, 1200 mg of red yeast rice per 2 capsules recall — FDA D-0727-2021
Marketed Without an Approved NDA/ANDA
Class IIFDA: TerminatedHigh Performance Formulas, LLC (HPF, LLC)
DrugAug 25, 2021
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles recall — FDA D-0753-2021
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Class IIFDA: TerminatedZydus Pharmaceuticals (USA) Inc.
DrugAug 25, 2021
Teva Pharmaceuticals USA Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL recall — FDA D-0742-2021
Lack of Assurance of Sterility
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugAug 25, 2021
DuPont Nutrition USA Avicel, Mirocrystalline cellulose recall — FDA D-0728-2021
Out of specification results for conductivity.
Class IIIFDA: TerminatedDuPont Nutrition USA, Inc.
DrugAug 25, 2021
Teva Pharmaceuticals USA Haloperidol Decanoate Injection 100 mg/mL recall — FDA D-0732-2021
Lack of Assurance of Sterility
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugAug 25, 2021
GAVILYTE - C GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with recall — FDA D-0726-2021
Failed Stability Specification; Out of specification for Osmolarity
Class IIFDA: TerminatedNovel Laboratories, Inc. d.b.a LUPIN
DrugAug 25, 2021
COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) Combipatch recall — FDA D-0725-2021
Failed Stability Specifications; out of specification for shear.
Class IIFDA: OngoingNoven Pharmaceuticals Inc.
DrugAug 25, 2021
Teva Pharmaceuticals USA Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL recall — FDA D-0743-2021
Lack of Assurance of Sterility
Class IIFDA: TerminatedTeva Pharmaceuticals USA
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.