FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass II
Dakota Honey Company
- Product
- Dakota Honey Company the Honey Flight. 4 Flavors of Spreada…
- Reason
- Foreign object (stainless steel dust/flakes or shreds of plastic)
- Published
- May 20, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass II
Dakota Honey Company
- Product
- Dakota Honey Company Spreadable Spun Honey, Jalapeno. Stir…
- Reason
- Foreign object (stainless steel dust/flakes or shreds of plastic)
- Published
- May 20, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass II
Dakota Honey Company
- Product
- Dakota Honey Company Spreadable Spun Honey, Salted Caramel.…
- Reason
- Foreign object (stainless steel dust/flakes or shreds of plastic)
- Published
- May 20, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass II
Dakota Honey Company
- Product
- Dakota Honey Company Spreadable Spun Honey, Cinnamon-Infused…
- Reason
- Foreign object (stainless steel dust/flakes or shreds of plastic)
- Published
- May 20, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass II
Dakota Honey Company
- Product
- Dakota Honey Company Spreadable Spun Honey, Original. Stir…
- Reason
- Foreign object (stainless steel dust/flakes or shreds of plastic)
- Published
- May 20, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass I
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
by B BRAUN MEDICAL INC
- Reason
- Presence of Particulate Matter.
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
by Acella Pharmaceuticals, LLC
- Reason
- Chemical contamination; presence of lead and lithium above specification
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
by Breckenridge Pharmaceutical, Inc.
- Reason
- CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
by JB Chemicals and Pharmaceuticals Ltd
- Reason
- Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.
by Teva Pharmaceuticals USA, Inc
- Reason
- Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41
by CareFusion 213, LLC
- Reason
- Lack of assurance of Sterility: potential product contamination
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
by CareFusion 213, LLC
- Reason
- Lack of assurance of Sterility: potential product contamination
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
by Ajanta Pharma Ltd.
- Reason
- CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
by Ajanta Pharma Ltd.
- Reason
- CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India
by Ajanta Pharma Ltd.
- Reason
- CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility: Potential leaks from perforations in bags.
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass III
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
by Unichem Pharmaceuticals USA Inc.
- Reason
- Subpotent drug
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
2026 recordClass II
Green Organic Vegetables
- Product
- Woodstock Organic Shelled Edamame 10 oz. and 48 oz.
- Reason
- Foreign object: metal pieces
- Published
- May 13, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0282-59.
by Hikma Pharmaceuticals USA INC
- Reason
- This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
- Published
- May 6, 2026
- 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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