FDA Recall
Ongoing
Historical recordClass II
Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25
by Eugia US LLC
- Reason
- Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
- Published
- June 25, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
by Aurobindo Pharma USA Inc
- Reason
- cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
- Published
- June 25, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
by Amneal Pharmaceuticals, LLC
- Reason
- Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
- Published
- June 18, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass III
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.
by Macleods Pharmaceuticals Ltd
- Reason
- Presence of a foreign substance: black hair found embedded in tablet.
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
by Ascend Laboratories, LLC
- Reason
- Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88
by Ascend Laboratories, LLC
- Reason
- Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
by SAINI TRADE INC
- Reason
- Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
by SAINI TRADE INC
- Reason
- Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
by SAINI TRADE INC
- Reason
- Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
by SAINI TRADE INC
- Reason
- Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
by SAINI TRADE INC
- Reason
- Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with undeclared propoxyphenylsildenafil and sildenafil.
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15
by AvKARE
- Reason
- Failed Dissolution Specifications
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
by AvKARE
- Reason
- Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-142-71
by Alembic Pharmaceuticals Limited
- Reason
- Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
NOW Foods
- Product
- NOW Nutritional Yeast Powder, Nt. Wt. 10oz. UPC 7 33739 024…
- Reason
- regular yeast was inadvertently packaged as nutritional yeast
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
R&M TRADING LLC
- Product
- Instant Milk Tea Brown Sugar Flavor, R&M Refresher brand, B0…
- Reason
- The Instant Milk Tea Powder's ingredients statement declares Non-Dairy Creamer (Whey Powder, Sodium Caseinate) but does not specify milk.
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
R&M TRADING LLC
- Product
- Instant Milk Tea Original Flavor, R&M Refresher brand, B0D71…
- Reason
- The Instant Milk Tea Powder's ingredients statement declares Non-Dairy Creamer (Whey Powder, Sodium Caseinate) but does not specify milk.
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
R&M TRADING LLC
- Product
- Instant Milk Tea Matcha Flavor, R&M Refresher brand, B0D71Y8…
- Reason
- The Instant Milk Tea Powder's ingredients statement declares Non-Dairy Creamer (Whey Powder, Sodium Caseinate) but does not specify milk.
- Published
- June 18, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
R&M TRADING LLC
- Product
- Instant Milk Tea Taro Flavor, R&M Refresher brand, B0D72CMLB…
- Reason
- The Instant Milk Tea Powder's ingredients statement declares Non-Dairy Creamer (Whey Powder, Sodium Caseinate) but does not specify milk.
- Published
- June 18, 2025
- 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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