Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles recall — FDA D-0216-2026
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Complete FDA and NHTSA recall records dated in December 2025.
These records include useful source details for the selected month.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
foreign objects (black plastic planting material) in granulated onion
Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303
Undeclared wheat.
Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per…
Potential metal fragments from supplier raw material (downstream recall)
foreign objects (black plastic planting material) in granulated onion
The 3oz. sealed packet of Caesar Dressing in Costco Chicken Sandwich w/ Caesar Salad may contain plastic material.
Undeclared Sulfite. Shrimp may contain 3.4mg Sulfur Dioxide per serving and label does not declare Sulfite.
Product is mislabeled - the labeling contains incorrect ingredient information and fails to declare milk as an allergen
Undeclared Soy
Potential metal fragments from supplier raw material (downstream recall)
Potential contamination with Listeria monocytogenes.
Potential metal fragments from supplier raw material (downstream recall)
Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed.
Elevated levels of lead. FDA ground cinnamon sample was found to contain 2.92 mg/kg.
Twin Sisters Creamery's recall of cheese products due to WSDA testing that identified potential STEC and E. coli O103 contamination. Whole Foods Market received affected products through…
Undeclared allergens - wheat and soy
FDA environmental sample identified the presence of Listeria monocytogenes in the processing area where cheese was packaged.
Twin Sisters Creamery's recall of cheese products due to WSDA testing that identified potential STEC and E. coli O103 contamination. Whole Foods Market received affected products through…
CGMP Deviations
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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.