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
🇺🇸 United States
Terminated
Historical recordClass II
NRC Nutrition Pty Ltd
- Product
- Preconception Multi for Women 60 capsules packaged in bliste…
- Reason
- inconsistent blending of iodine in the product
- Published
- June 18, 2025
- Distribution
- Texas, Minnesota, California, Indiana an…
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
View recall →
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
Country Favor Inc.
- Product
- Best Taste Brand Salted Shrimp Paste Sauce; ING: Shrimp, sug…
- Reason
- Product contains undeclared FD&C Red #3
- Published
- June 11, 2025
- Distribution
- CT, GA, IL, IN KS, KY, LA, MA, MN, MO, M…
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
🇺🇸 United States
Terminated
Historical recordClass II
Treehouse Foods
- Product
- Sysco Classic chocolate pudding, 7lb #10 metal can, UPC 0748…
- Reason
- Post process damage to containers, potential for microbial growth, swollen and or exploding containers
- Published
- June 11, 2025
- Distribution
- Arizona Arkansas California Florida Idah…
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 →
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
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 →
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.