FDA Recall
Ongoing
Historical recordClass I
Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-309-02 (carton), NDC #: 49884-309-52 (blisters).
by ENDO USA, Inc.
- Reason
- Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-307-02 (carton), NDC #: 49884-307-52 (blisters).
by ENDO USA, Inc.
- Reason
- Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 tablets per carton (10 blister cards containing 6 tablets each), Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-306-02 (carton), NDC #: 49884-306-52 (blisters).
by ENDO USA, Inc.
- Reason
- Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).
by ENDO USA, Inc.
- Reason
- Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
- Published
- January 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia.
by Buy-Herbal
- Reason
- Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
- Published
- January 15, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass III
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
by AvKARE
- Reason
- LABELING: LABEL MIX-UP
- Published
- January 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.
by AvKARE
- Reason
- LABELING: LABEL MIX-UP
- Published
- January 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
by Hikma Injectables USA Inc
- Reason
- Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
- Published
- January 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25
by Hikma Injectables USA Inc
- Reason
- Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
- Published
- January 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
by VIONA PHARMACEUTICALS INC
- Reason
- Crystallization
- Published
- January 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
by VIONA PHARMACEUTICALS INC
- Reason
- Crystallization
- Published
- January 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles
by GNMart LLC
- Reason
- Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
- Published
- January 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01
by SOMERSET THERAPEUTICS LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- January 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
by AvKARE
- Reason
- Failed Dissolution Specifications
- Published
- January 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sam'S Club
- Product
- Member's Mark Hatch Chile Chicken Enchiladas, ready to cook,…
- Reason
- Presence of Listeria monocytogenes
- Published
- January 8, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grimmway Enterprises, Inc. dba Grimmway Farms
- Product
- --- Organic Whole Carrots --- Organic Clip Carrots 50 Lbs C…
- Reason
- Potential contamination with E. coli O121:H19
- Published
- January 8, 2025
- Distribution
- Distribution Centers located in U.S. Sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grimmway Enterprises, Inc. dba Grimmway Farms
- Product
- --- Organic Whole Carrots --- Organic Carrot 125/6 Cal-Orga…
- Reason
- Potential contamination with E. coli O121:H19
- Published
- January 8, 2025
- Distribution
- Distribution Centers located in U.S. Sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grimmway Enterprises, Inc. dba Grimmway Farms
- Product
- --- Organic Baby Carrots --- Organic Baby Carrots 25 Grimmwa…
- Reason
- Potential contamination with E. coli O121:H19
- Published
- January 8, 2025
- Distribution
- Distribution Centers located in U.S. Sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grimmway Enterprises, Inc. dba Grimmway Farms
- Product
- --- Organic Baby Carrots --- Orangic Baby Peeled Carrots 13/…
- Reason
- Potential contamination with E. coli O121:H19
- Published
- January 8, 2025
- Distribution
- Distribution Centers located in U.S. Sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Grimmway Enterprises, Inc. dba Grimmway Farms
- Product
- --- Organic Baby Carrots --- Organic Baby Peeled Carrots 12/…
- Reason
- Potential contamination with E. coli O121:H19
- Published
- January 8, 2025
- Distribution
- Distribution Centers located in U.S. Sta…
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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