FDA Recall
TerminatedTerminated: February 6, 2026Historical recordClass II
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
by NATCO Pharma Limited
- Reason
- CGMP Deviations
- Published
- April 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: April 4, 2025Historical recordClass II
Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659-06
by Lupin Pharmaceuticals Inc.
- Reason
- Subpotent Drug
- Published
- April 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 11, 2024Historical recordClass I
Backstage Center DBA CTC Seller
- Product
- Alipotec Raiz de Tejocote dietary supplements, Net. Wt. 0.35…
- Reason
- The "Alipotec King" Alipotec Raiz de Tejocote product was found to contain toxic yellow oleander instead of tejocote.
- Published
- April 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 23, 2024Historical recordClass II
The Coastal Companies DBA Hearn Kirkwood
- Product
- Egg salad sandwich packaged in clamshell for individual sale…
- Reason
- Tuna salad sandwich was mislabeled as an egg salad sandwich. There is an undeclared allergen of fish (Tuna).
- Published
- April 17, 2024
- Distribution
- Product was sold to institutions, hospit…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 23, 2024Historical recordClass II
Whitley Peanut Factory, Inc.
- Product
- Whitley's Peanut Factory, Deluxe Nut Mix, 12oz (340g), Elect…
- Reason
- Undeclared Allergen (peanuts, milk, soy, wheat, and sesame).
- Published
- April 17, 2024
- Distribution
- The recalled product was distributed to…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 22, 2024Historical recordClass II
RAJA FOODS LLC
- Product
- SWAD BRAND CINNAMON POWDER in clear plastic 3.5 OZ bags, UPC…
- Reason
- Product tested positive for lead
- Published
- April 17, 2024
- Distribution
- NY, NJ, PA, MD, VA, CT, MA, NH, TN, FL,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 24, 2024Historical recordClass II
Spices USA Inc.
- Product
- Tasty-Sawa Cinnamon Ground, Net Wt. 55.11 lbs, paper bag (bu…
- Reason
- Due to elevated levels of lead in ground cinnamon
- Published
- April 17, 2024
- Distribution
- Distributors in 3 states: FL, GA, and NC…
View recall →
FDA Recall
TerminatedTerminated: September 30, 2025Historical recordClass III
Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01.
by X-Gen Pharmaceuticals Inc.
- Reason
- Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
- Published
- April 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: September 30, 2025Historical recordClass III
Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.
by X-Gen Pharmaceuticals Inc.
- Reason
- Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
- Published
- April 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
by IntegraDose Compounding Services LLC
- Reason
- Lack of Assurance of Sterility: leaking bags
- Published
- April 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 1, 2025Historical recordClass II
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
by B. Braun Medical Inc
- Reason
- Lack of assurance of sterility: bags have the potential to leak..
- Published
- April 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
- Published
- April 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 11, 2025Historical recordClass II
Turkana Food Inc.
- Product
- Sekeroglu Lokum Love Turkish Delight With Pistachio And Pome…
- Reason
- Product contains Acid Red 18
- Published
- April 10, 2024
- Distribution
- Distributed to retail stores in CA, CT,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 11, 2025Historical recordClass II
Turkana Food Inc.
- Product
- Sekeroglu Lokum Love Turkish Delight Mixed With Pistachio An…
- Reason
- Product contains Acid Red 18
- Published
- April 10, 2024
- Distribution
- Distributed to retail stores in CA, CT,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 9, 2025Historical recordClass II
Waiakea Bottling Inc
- Product
- Waiakea Hawaiian Volcanic Water Naturally Alkaline Electrol…
- Reason
- Consumer complaints involving floating particles.
- Published
- April 10, 2024
- Distribution
- U.S. distribution to the following: PA,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: September 12, 2024Historical recordClass II
AJI MORI SAUCE CORP
- Product
- AJI MORI***CHILLIMAMI SAUCE***UMAMI BOMB***NET WT. 250ml. Pa…
- Reason
- Potential contamination with Clostridium botulinum
- Published
- April 10, 2024
- Distribution
- Products were distributed direct to cons…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 27, 2024Historical recordClass II
The Coca-Cola Company
- Product
- Powerade Mountain Berry Blast - 20oz PET bottles 24 vari…
- Reason
- The potential presence of a foreign metal object in the product, i.e. a stainless-steel ring.
- Published
- April 10, 2024
- Distribution
- U.S. distribution to 760 consignees in S…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 27, 2024Historical recordClass II
The Coca-Cola Company
- Product
- Powerade Zero Fruit Punch - 20oz PET bottles 24 variety p…
- Reason
- The potential presence of a foreign metal object in the product, i.e. a stainless-steel ring.
- Published
- April 10, 2024
- Distribution
- U.S. distribution to 760 consignees in S…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 27, 2024Historical recordClass II
The Coca-Cola Company
- Product
- Powerade Zero Mixed Berry - 20 oz PET bottles 24 variety pac…
- Reason
- The potential presence of a foreign metal object in the product, i.e. a stainless-steel ring.
- Published
- April 10, 2024
- Distribution
- U.S. distribution to 760 consignees in S…
View recall →
FDA Recall
OngoingHistorical recordClass I
Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01
by Par Sterile Products LLC
- Reason
- Presence of Particulate Matter.
- Published
- April 3, 2024
- 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.
