FDA Recall
Terminated
Historical 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
View recall →
FDA Recall
Ongoing
Historical 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
View recall →
FDA Recall
Ongoing
Historical 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
View recall →
FDA Recall
Ongoing
Historical 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
View recall →
FDA Recall
Ongoing
Historical 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
View recall →
FDA Recall
Ongoing
Historical 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
View recall →
FDA Recall
Ongoing
Historical 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
View recall →
FDA Recall
Ongoing
Historical 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
View recall →
FDA Recall
Ongoing
Historical 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
Ongoing
Historical 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
Ongoing
Historical 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
View recall →
FDA Recall
Ongoing
Historical 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 →
FDA Recall
Completed
Historical recordClass II
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,
by Winder Laboratories, LLC
- Reason
- Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- Published
- June 19, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GRANDE CHEESE COMPANY
- Product
- Grande Grande Primo Y45 Cultured Dairy Product. Product Cod…
- Reason
- Possible Salmonella contamination.
- Published
- June 19, 2024
- Distribution
- AR, CA, CO, GA, ID, IL, IN, KS, KY, LA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GRANDE CHEESE COMPANY
- Product
- Grande Ultra 9150 Whey Protein Isolate. Product Code: 3232…
- Reason
- Possible Salmonella contamination.
- Published
- June 19, 2024
- Distribution
- AR, CA, CO, GA, ID, IL, IN, KS, KY, LA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GRANDE CHEESE COMPANY
- Product
- Grande Ultra 8000 Nutritional Whey Protein Isolate. SKU 322…
- Reason
- Possible Salmonella contamination.
- Published
- June 19, 2024
- Distribution
- AR, CA, CO, GA, ID, IL, IN, KS, KY, LA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GRANDE CHEESE COMPANY
- Product
- Grande Ultra 9100 Functional Whey Protein Isolate. SKU 3213…
- Reason
- Possible Salmonella contamination.
- Published
- June 19, 2024
- Distribution
- AR, CA, CO, GA, ID, IL, IN, KS, KY, LA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GRANDE CHEESE COMPANY
- Product
- Grande Bravo 600 Functional Whey Protein SKU 32106. 34% Pr…
- Reason
- Possible Salmonella contamination.
- Published
- June 19, 2024
- Distribution
- AR, CA, CO, GA, ID, IL, IN, KS, KY, LA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GRANDE CHEESE COMPANY
- Product
- Grande Bravo 550 Functional Whey Protein SKU 32105. 34% Pr…
- Reason
- Possible Salmonella contamination.
- Published
- June 19, 2024
- Distribution
- AR, CA, CO, GA, ID, IL, IN, KS, KY, LA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
GRANDE CHEESE COMPANY
- Product
- Grande Bravo 500 Functional Whey Protein SKU 32103. 34% Pr…
- Reason
- Possible Salmonella contamination.
- Published
- June 19, 2024
- Distribution
- AR, CA, CO, GA, ID, IL, IN, KS, KY, LA,…
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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