FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Tay's Sales and Distribution
- Product
- Full Spectrum Cold Pressed Hemp Oil Gummies, Fruit Punch, 1.…
- Reason
- Sub-ingredients not declared for sunflower butter.
- Published
- November 22, 2023
- Distribution
- Direct to consumer and retail establishm…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Tokai Denpun USA Inc
- Product
- Takumi brand frozen tuna ground meat, raw but ready to eat,…
- Reason
- Histamine, high total plate count, coliforms, and E.coli (serotype is unknown).
- Published
- November 22, 2023
- Distribution
- Distributed in CA, NC, NV, and TX betwee…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
TH Searcy LLC
- Product
- Guilt Free No Sugar Added Ice Cream Homemade Vanilla 1.5qts
- Reason
- Undeclared Egg
- Published
- November 22, 2023
- Distribution
- Wholesale to 3 distributors: Walmart, Kr…
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FDA Recall
Terminated
Historical recordClass I
2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11
by Pfizer Inc.
- Reason
- Presence of Particulate Matter: identified as glass.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4904-11
by Pfizer Inc.
- Reason
- Presence of Particulate Matter: identified as glass.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24
by Pfizer Inc.
- Reason
- Presence of Particulate Matter: identified as glass.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935
by Grato Holdings, Inc.
- Reason
- Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
- Published
- November 15, 2023
- Distribution
- Distributed to one direct account in Flo…
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FDA Recall
Completed
Historical recordClass II
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass II
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
Completed
Historical recordClass II
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass III
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11
by Zyla Life Sciences US Inc.
- Reason
- Sub-potent Drug: Lower potency than labeled.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
by VistaPharm LLC
- Reason
- Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications: Out of specification for dissolution.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79
by MEDLINE INDUSTRIES, LP - Northfield
- Reason
- CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
by Amneal Pharmaceuticals of New York, LLC
- Reason
- Failed Dissolution Specifications
- Published
- November 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
by Taro Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass III
Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
by AbbVie Inc.
- Reason
- Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
- Published
- November 15, 2023
- Distribution
- Distributed in the US. No government or…
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FDA Recall
Terminated
Historical recordClass II
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05
by Par Sterile Products LLC
- Reason
- Crystallization; identified as Buprenorphine free base
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
- Published
- November 15, 2023
- 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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