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
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
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 →
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 →
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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