Search Product Recalls

FDAJul 27, 2022AL, CA, IN +2 more• Pine Pharmaceuticals, LLC

Azacitidine Injection (Amerisource) – Subpotent Drug (2022)

Subpotent Drug

Class IIILow

FDAJul 27, 2022Nationwide• Amerisource Health Services LLC

Pantoprazole Sodium Suspension (Sun Pharmaceutical) – Discoloration (2022)

Discoloration

Class IIModerate

FDAJul 25, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

FentaNYL Citrate IV Bags (SterRx) – Sterility Issue (2022)

Lack of Assurance of Sterility

FDAJul 25, 2022Nationwide• SterRx, LLC

FentaNYL Citrate IV Bags (SterRx) – Sterility Concern (2022)

Lack of Assurance of Sterility

FDAJul 25, 2022Nationwide• SterRx, LLC

Sysco Imperial Thickened Dairy Drink (Lyons Magnus) – bacterial risk (2022)

Findings and potential for Cronobacter sakazakii and Clostridium botulinum.

FDAJul 22, 2022IN, OH• Teva Pharmaceuticals USA Inc

Azacitidine Injection (Teva) – Subpotent Medication (2022)

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

Class IIILow

SANGTER Energy Capsules (RFR) – Undeclared Ingredient (2022)

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.

FDAJul 22, 2022Nationwide• Distributor RFR, LLC.

Sysco Imperial Thickened Dairy Drink (Lyons Magnus) – bacterial risk (2022)

Findings and potential for Cronobacter sakazakii and Clostridium botulinum.

Lyons Ready Care Thickened Dairy Drink (Lyons Magnus) – Bacterial Contamination (2022)

Findings and potential for Cronobacter sakazakii and Clostridium botulinum.

Organic Valley Chocolate Milk (Lyons Magnus) – bacteria risk (2022)

Findings and potential for Cronobacter sakazakii and Clostridium botulinum.

Lyons Ready Care Thickened Dairy Drink (Lyons Magnus) – bacteria risk (2022)

Findings and potential for Cronobacter sakazakii and Clostridium botulinum.

Matzim LA (Teva) – Dissolution Specification Failure (2022)

Failed Dissolution Specifications: below specification limits for dissolution.

FDAJul 21, 2022Nationwide• Teva Pharmaceuticals USA Inc

SUSTANGO Capsules (Ultra Supplement) – Undeclared Ingredient (2022)

Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.

FDAJul 21, 2022Nationwide• Ultra Supplement LLC

Matzim LA Tablets (Teva) – Dissolution Failure (2022)

Failed Dissolution Specifications: below specification limits for dissolution.

FDAJul 21, 2022Nationwide• Teva Pharmaceuticals USA Inc

Lamotrigine Tablets (AVKARE) – Strength Labeling Error (2022)

Labeling: Label Error on Declared Strength

Class IIILow

FDAJul 20, 2022Nationwide• AVKARE Inc.

Prednisone Tablets (Strides Pharma) – Foreign Tablet Contamination (2022)

Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets

FDAJul 19, 2022Nationwide• Strides Pharma Inc.

Irbesartan Tablets (Jubilant Cadista) – Dissolution Failure (2022)

Failed Dissolution Specifications

FDAJul 18, 2022Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Irbesartan Tablets (Jubilant Cadista) – Dissolution Failure (2022)

Failed dissolution specifications.

FDAJul 18, 2022Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Fulvestrant Injection (Zydus) – Impurity Specification (2022)

Failed Impurities/Degradation Specifications