FDA Recall
🇺🇸 United States
TerminatedTerminated: August 12, 2024Historical recordClass II
Classic Delight LLC
- Product
- (Item 6757) Classic Delight Twin Breaded Chicken Sliders - I…
- Reason
- Possibly contaminated with Listeria monocytogenes
- Published
- July 3, 2024
- Distribution
- Product distributed in Arkansas, Califor…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: August 12, 2024Historical recordClass II
Classic Delight LLC
- Product
- (Item 314) Classic Delight Turkey & Cheese Sub Sandwiches Pa…
- Reason
- Possibly contaminated with Listeria monocytogenes
- Published
- July 3, 2024
- Distribution
- Product distributed in Arkansas, Califor…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: August 12, 2024Historical recordClass II
Classic Delight LLC
- Product
- (Item 311) Classic Delight Turkey Ham & Cheese Sub
- Reason
- Possibly contaminated with Listeria monocytogenes
- Published
- July 3, 2024
- Distribution
- Product distributed in Arkansas, Califor…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 14, 2025Historical recordClass I
GLOBAL MIX INC.
- Product
- Tejocote Root Products under the following brands: Eva Nutri…
- Reason
- Product contains Yellow Oleander
- Published
- July 3, 2024
- Distribution
- Alabama, Alaska, California, Colorado, C…
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FDA Recall
TerminatedTerminated: April 7, 2026Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Published
- June 26, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-34
by Teva Pharmaceuticals USA, Inc
- Reason
- Subpotent Drug
- Published
- June 26, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 21, 2025Historical recordClass II
Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822-51349-4; Kroger, with UPC 0-41260-35275-1; Harris Teeter, with UPC 0-72036-75051-8; CVS, with UPC 0-50428-31702-0
by Consumer Product Partners, LLC
- Reason
- Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
- Published
- June 26, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 29, 2025Historical recordClass II
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC 68180-407-03
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Content Uniformity Specifications
- Published
- June 26, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370
by MexHealth LLC
- Reason
- Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
- Published
- June 26, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass III
Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10
by Eugia US LLC
- Reason
- Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
- Published
- June 26, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30
by Eugia US LLC
- Reason
- Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
- Published
- June 26, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: September 25, 2024Historical recordClass I
Fresh Start Produce Sales, Inc.
- Product
- Whole Cucumber, bulk cardboard boxes, 1 1/9 Bu, 60-72 ct cuc…
- Reason
- Due to Salmonella in Cucumbers
- Published
- June 26, 2024
- Distribution
- The product has been distributed in the…
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FDA Recall
OngoingHistorical recordClass I
Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
by Sagent Pharmaceuticals
- Reason
- Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
- Published
- June 19, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08
by Sagent Pharmaceuticals
- Reason
- Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
- Published
- June 19, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass III
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 30 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-0114-04
by Organon Llc
- Reason
- Defective Container
- Published
- June 19, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass III
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 14 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-03
by Organon Llc
- Reason
- Defective Container
- Published
- June 19, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass III
Asmanex Twisthaler, mometasone furoate inhalation powder, 220 mcg per actuation, 60 Metered Doses, Rx Only, Manuf. for: Organon LLC, a subsidiary of Organon & Co. Product of Singapore. NDC 78206-114-02
by Organon Llc
- Reason
- Defective Container
- Published
- June 19, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05
by Imprimis NJOF, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 19, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC: 71384-514-05
by Imprimis NJOF, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- June 19, 2024
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-01. Diluent Vial Label: Diluent, 5mL, Sterile single use, Rx only, Manufactured for Pacira Pharmaceuticals Inc., NDC 65250-002-01. Carton Label: Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01.
by PACIRA PHARMACEUTICALS INC
- Reason
- Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
- Published
- June 19, 2024
- 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.
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