FDA Recall
Ongoing
Historical recordClass II
Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications
- Published
- November 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11
by Zyla Life Sciences US Inc.
- Reason
- Sub-potent Drug: Lower potency than labeled.
- Published
- November 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
by VistaPharm LLC
- Reason
- Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
- Published
- November 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications: Out of specification for dissolution.
- Published
- November 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79
by MEDLINE INDUSTRIES, LP - Northfield
- Reason
- CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
- Published
- November 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Failed Dissolution Specifications
- Published
- November 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
by Taro Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
- Published
- November 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05
by Par Sterile Products LLC
- Reason
- Crystallization; identified as Buprenorphine free base
- Published
- November 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
- Published
- November 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gills Onions, LLC
- Product
- Ready Set Serve 4/5 LB CTN FRESH 1/4" DICED YLW ONIONS W/ZIP
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gills Onions, LLC
- Product
- Ready Set Serve 2/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/…
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gills Onions, LLC
- Product
- PEAK 4/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIPPER
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gills Onions, LLC
- Product
- PEAK 2/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIP
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gills Onions, LLC
- Product
- PEAK 2/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIP
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gills Onions, LLC
- Product
- Imperial Fresh 2/5 LB CTN FRESH 1/4" SLIVERED YLW ONIONS W/Z…
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gills Onions, LLC
- Product
- Imperial Fresh 2/5 LB CTN FRSH 1/4" DICED YLW ONIONS W/ZIP
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gills Onions, LLC
- Product
- Imperial Fresh 2/5 LB CTN FRSH 1/4" DICED RED ONIONS W/ZIPPE…
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gills Onions, LLC
- Product
- 4/5 LB CTN FRESH 1/4" DICED YLW ONIONS W/ZIPPER DARDEN
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gills Onions, LLC
- Product
- Gills Onions 2/5 LB CTN FRESH 3/8" DICED RED ONIONS WITH ZIP…
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Gills Onions, LLC
- Product
- Gills Onions 1/5 LB CTN FRESH 1/4" DICED RED ONIONS W/ZIPPER
- Reason
- Potential contamination with Salmonella Thompson
- Published
- November 15, 2023
- Distribution
- Distributors in Canada AB, BC, NB, NS,…
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.