FDA Recall
Terminated
Historical 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
Ongoing
Historical 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
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FDA Recall
🇺🇸 United States
Terminated
Historical 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,…
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FDA Recall
🇺🇸 United States
Terminated
Historical 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
Terminated
Historical 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,…
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FDA Recall
🇺🇸 United States
Terminated
Historical 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…
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FDA Recall
🇺🇸 United States
Terminated
Historical 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
Terminated
Historical 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…
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FDA Recall
🇺🇸 United States
Terminated
Historical 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
Ongoing
Historical 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 →
FDA Recall
Terminated
Historical recordClass II
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62
by Teva Pharmaceuticals USA, Inc
- Reason
- Failed Dissolution Specifications
- Published
- April 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01
by Apothecus Pharmaceutical Corp.
- Reason
- cGMP Diviations
- Published
- April 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Failed dissolution specifications
- Published
- April 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359
by SCA Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- April 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 70004090809
by SCA Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- April 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 70004090812
by SCA Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- April 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025
by SCA Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- April 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID for KitCheck compatibility)
by SCA Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- April 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12, Bar Code 700040081612.
by SCA Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- April 3, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.
by SCA Pharmaceuticals, LLC
- Reason
- Lack of Assurance of Sterility
- 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.
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