FDA Recall
OngoingHistorical recordClass II
Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-406-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
- Published
- December 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
by Apotex Corp.
- Reason
- Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
- Published
- December 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)1000-count bottle, NDC#: 60505-0084-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
by Apotex Corp.
- Reason
- Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
- Published
- December 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
by Apotex Corp.
- Reason
- Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
- Published
- December 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.
by Apotex Corp.
- Reason
- Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
- Published
- December 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 19, 2024Historical recordClass II
United Packers, LLC
- Product
- Sprite packaged in 12oz aluminum cans - 12 pack fridge pack
- Reason
- Potential foreign material
- Published
- December 6, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 19, 2024Historical recordClass II
United Packers, LLC
- Product
- Fanta Orange packaged in 12oz aluminum cans - 12 pack fridge…
- Reason
- Potential foreign material
- Published
- December 6, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 19, 2024Historical recordClass II
United Packers, LLC
- Product
- Diet Coke packaged in 12oz aluminum cans - 12 pack fridge pa…
- Reason
- Potential foreign material
- Published
- December 6, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 25, 2024Historical recordClass II
The Coastal Companies DBA Hearn Kirkwood
- Product
- Le Croissant Turkey & Cheddar Net Wt. 5.5oz (156g) UPC:76637…
- Reason
- Undeclared milk and soy
- Published
- December 6, 2023
- Distribution
- Distributed to consignees in Alabama, Co…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 25, 2024Historical recordClass II
The Coastal Companies DBA Hearn Kirkwood
- Product
- Le Croissant Ham & Swiss Net Wt. 5.5oz (156g) UPC:7663752616…
- Reason
- Undeclared milk and soy
- Published
- December 6, 2023
- Distribution
- Distributed to consignees in Alabama, Co…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 25, 2024Historical recordClass I
The Coastal Companies DBA Hearn Kirkwood
- Product
- Le Croissant Tuna Salad Net Wt. 5.8oz (164g) UPC:76637526160…
- Reason
- Undeclared milk and soy
- Published
- December 6, 2023
- Distribution
- Distributed to consignees in Alabama, Co…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 25, 2024Historical recordClass I
The Coastal Companies DBA Hearn Kirkwood
- Product
- Le Croissant Chicken Salad Net Wt. 5.8oz (164g) UPCs:7663757…
- Reason
- Undeclared milk and soy
- Published
- December 6, 2023
- Distribution
- Distributed to consignees in Alabama, Co…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 25, 2024Historical recordClass II
The Coastal Companies DBA Hearn Kirkwood
- Product
- Breakfast Sandwich Bacon Egg & Cheddar Croissant Net Wt. 5.2…
- Reason
- Undeclared milk and soy
- Published
- December 6, 2023
- Distribution
- Distributed to consignees in Alabama, Co…
View recall →
FDA Recall
OngoingHistorical recordClass I
LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0587-1
by Cardinal Health Inc.
- Reason
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Published
- November 29, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass I
LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1
by Cardinal Health Inc.
- Reason
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Published
- November 29, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass I
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC:70000-0090-2 (Carton); 70000-0090-1 (Bottle)
by Cardinal Health Inc.
- Reason
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Published
- November 29, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass I
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017. Made in India NDC: 70000-0090-1
by Cardinal Health Inc.
- Reason
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Published
- November 29, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass I
LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio. 43017, Made in India NDC: 70000-0089-1
by Cardinal Health Inc.
- Reason
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Published
- November 29, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass I
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1
by Cardinal Health Inc.
- Reason
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Published
- November 29, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass I
ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intravenous Infusion Only, Rx Only, Manufactured and Distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645, (Vial: NDC 51754-1007-1; Carton: 51754-1007-3).
by Exela Pharma Sciences LLC
- Reason
- Presence of Particulate Matter: Silicone
- Published
- November 29, 2023
- 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.
Read the full medical disclaimer.