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
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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
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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 →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
R&M TRADING LLC
- Product
- Instant Milk Tea Honeydew Flavor, R&M Refresher brand, B0D72…
- 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
Ongoing
Historical recordClass II
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5
by Consumer Product Partners, LLC
- Reason
- Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
- Published
- June 11, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4
by Apotex Corp.
- Reason
- Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
- Published
- June 11, 2025
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass II
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Carton); 13668-473-70 (Blister)
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
- Published
- June 11, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30
by Torrent Pharma Inc.
- Reason
- CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
- Published
- June 11, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).
by Amerisource Health Services LLC
- Reason
- cGMP deviations
- Published
- June 11, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
GNC Holdings LLC
- Product
- GNC Women's 30+ Vitapak, Carton of 30 Sachets. Each sachet…
- Reason
- Undeclared Fish allergen (parvalbumin).
- Published
- June 11, 2025
- Distribution
- The adulterated product was distributed…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Nordic Naturals, Inc.
- Product
- Nordic Naturals Zero Sugar Kids Multivitamin Supplement - Gu…
- Reason
- Product is mislabeled.
- Published
- June 11, 2025
- Distribution
- Domestic: AK, AZ, CA, CO, FL, GA, ID, IN…
View recall →
FDA Recall
Ongoing
Historical recordClass I
ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA Nutrition Supplement....rgy and Endurance, UPC X004BB9Z8N
by EnShiShiXiangNiShangMaoYouXianGongSi
- Reason
- Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
- Published
- June 4, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- OOS results reported for the Dissolution (by UV) test.
- Published
- June 4, 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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