FDA Recall
OngoingHistorical recordClass II
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.
by Northwind Pharmaceuticals LLC
- Reason
- Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Published
- September 24, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.
by B BRAUN MEDICAL INC
- Reason
- Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
- Published
- September 24, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem. PA 18018, NDC 0264-7385-60.
by B BRAUN MEDICAL INC
- Reason
- Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.
- Published
- September 24, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10.
by Sandoz Inc
- Reason
- cGMP deviations: Temperature excursion during transportation.
- Published
- September 24, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC#: 60687-463-01 (Individual Dose NDC: 60687-463-11)
by Amerisource Health Services LLC
- Reason
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Published
- September 24, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 (10x10) blisterpack per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 60687-452-01 (Individual unit dose blister pack NDC: 60687-452-11)
by Amerisource Health Services LLC
- Reason
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Published
- September 24, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11)
by Amerisource Health Services LLC
- Reason
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Published
- September 24, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, packaged as a) 50 (5x10) blisterpacks, NDC: 60687-430-65; (Individual Dose NDC: 60687-430-11); b) 100 (10x10) blisterpacks, NDC: 60687-430-01, (Individual Dose NDC: 60687-430-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
by Amerisource Health Services LLC
- Reason
- Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- Published
- September 24, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226
by Fagron Compounding Services
- Reason
- Lack of Assurance of Sterility
- Published
- September 24, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-432-03
by Ascend Laboratories, LLC
- Reason
- Superpotent drug
- Published
- September 24, 2025
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
OngoingHistorical recordClass II
Itacate Foods LLC
- Product
- CAMPSITE LENTEJAS Hearty lentil soup with a tomato and cilan…
- Reason
- Undeclared Yellow #5 and Yellow #6.
- Published
- September 24, 2025
- Distribution
- U.S. consignees: AK, AZ, CA, CO, GA, IL,…
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass II
Itacate Foods LLC
- Product
- CHARGE-UP CHILAQUILES Traditional Mexican breakfast consisti…
- Reason
- Undeclared Yellow #5 and Yellow #6.
- Published
- September 24, 2025
- Distribution
- U.S. consignees: AK, AZ, CA, CO, GA, IL,…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: November 5, 2025Historical recordClass I
Endico Potatoes Inc
- Product
- Endico brand PEAS & CARROTS; NET WT. 2.5 lbs (40 oz.) (1134…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- September 24, 2025
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
TerminatedTerminated: November 5, 2025Historical recordClass I
Endico Potatoes Inc
- Product
- Endico brand MIXED VEGETABLES; NET WT. 2.5 lbs (40 oz.) (113…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- September 24, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 28, 2026Historical recordClass I
PRIMO NO. 1 IN PRODUCE, INC
- Product
- Cucumber Sliced 8oz 8ct/4#AV, Cardboard Boxes
- Reason
- Product contaminated with Salmonella
- Published
- September 24, 2025
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 28, 2026Historical recordClass I
PRIMO NO. 1 IN PRODUCE, INC
- Product
- Vegetable Tray Cucumbers 3/2lb, Cardboard boxes
- Reason
- Product contaminated with Salmonella
- Published
- September 24, 2025
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 28, 2026Historical recordClass I
PRIMO NO. 1 IN PRODUCE, INC
- Product
- Cucumber Sliced PLD ¿ KBS 2/10lb, Cardboard Boxes
- Reason
- Product contaminated with Salmonella
- Published
- September 24, 2025
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 28, 2026Historical recordClass I
PRIMO NO. 1 IN PRODUCE, INC
- Product
- Cucumber Peeled Sliced KBS 2/5lb, Cardboard Boxes
- Reason
- Product contaminated with Salmonella
- Published
- September 24, 2025
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 28, 2026Historical recordClass I
PRIMO NO. 1 IN PRODUCE, INC
- Product
- Cucumbers Peeled/Dice 1/4" KBS 5LB, Cardboard boxes
- Reason
- Product contaminated with Salmonella
- Published
- September 24, 2025
- Distribution
- The recalled product was distributed to…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 28, 2026Historical recordClass II
Southwind Foods LLC dba Great American Seafood Imports Co.
- Product
- Best Yet; Arctic Shores; and Great American branded Frozen c…
- Reason
- Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)
- Published
- September 24, 2025
- Distribution
- Product was distriburted to the followin…
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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