FDA Recall
Ongoing
Historical recordClass II
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- Published
- June 4, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- Published
- June 4, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- Published
- June 4, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- Published
- June 4, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17
by Alembic Pharmaceuticals Limited
- Reason
- Failed Impurities/Degradation Specifications
- Published
- June 4, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Honey Heaven Wholesale Inc
- Product
- Kraft package is labeled as Hummingbird Organic Roasted Salt…
- Reason
- Undeclared hazelnut. The Oregon Trail Mix contains visible hazelnut and was mis-labeled as Organic Roasted Salted Cashews, but the label does not declare hazelnut.
- Published
- June 4, 2025
- Distribution
- Distributed in CA, OR, and WA
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
HAWAIIAN HOST CANDIES OF LA INC
- Product
- Mauna Loa Dark Chocolate Covered Macadamias product is a sna…
- Reason
- Undeclared almond and cashew.
- Published
- June 4, 2025
- Distribution
- Distributed in AZ, CA, CO, FL, HI, IL, M…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.
by KVK Tech, Inc.
- Reason
- cGMP deviations
- Published
- May 28, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.
by KVK Tech, Inc.
- Reason
- cGMP deviations
- Published
- May 28, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .
by AsttraZeneca Pharmaceuticals LP
- Reason
- Defective delivery system
- Published
- May 28, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
- Published
- May 28, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
- Published
- May 28, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.
by CareFusion 213, LLC
- Reason
- Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
- Published
- May 28, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Frobright Salsary, LLC
- Product
- Medium Salsa Costco item, is refrigerated product and packag…
- Reason
- Salsa products are recalled due to potential contamination with wood particles.
- Published
- May 28, 2025
- Distribution
- Distributed in AK, ID, OR, and WA.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Frobright Salsary, LLC
- Product
- Verde Salsa is refrigerated product, packaged in Polypropyle…
- Reason
- Salsa products are recalled due to potential contamination with wood particles.
- Published
- May 28, 2025
- Distribution
- Distributed in AK, ID, OR, and WA.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Frobright Salsary, LLC
- Product
- Mens Room Roasted Red Salsa is refrigerated product, package…
- Reason
- Salsa products are recalled due to potential contamination with wood particles.
- Published
- May 28, 2025
- Distribution
- Distributed in AK, ID, OR, and WA.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Frobright Salsary, LLC
- Product
- Pineapple Mango Salsa is refrigerated product, packaged in…
- Reason
- Salsa products are recalled due to potential contamination with wood particles.
- Published
- May 28, 2025
- Distribution
- Distributed in AK, ID, OR, and WA.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Frobright Salsary, LLC
- Product
- Traditional Salsa is refrigerated product, packaged in Polyp…
- Reason
- Salsa products are recalled due to potential contamination with wood particles.
- Published
- May 28, 2025
- Distribution
- Distributed in AK, ID, OR, and WA.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Frobright Salsary, LLC
- Product
- Hot Salsa is refrigerated product, packaged in Polypropylene…
- Reason
- Salsa products are recalled due to potential contamination with wood particles.
- Published
- May 28, 2025
- Distribution
- Distributed in AK, ID, OR, and WA.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Frobright Salsary, LLC
- Product
- Medium Salsa is refrigerated product, packaged in Polypropyl…
- Reason
- Salsa products are recalled due to potential contamination with wood particles.
- Published
- May 28, 2025
- Distribution
- Distributed in AK, ID, OR, and WA.
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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