FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Betty Buzz LLC
- Product
- Betty Buzz Sparkling Grapefruit - Non-alcoholic Beverage & M…
- Reason
- Beverage has off-odor
- Published
- December 14, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7 g each per carton,) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300025, NDC 42192-113-60
by Acella Pharmaceuticals, LLC
- Reason
- Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
- Published
- December 7, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton, NDC49032-273-30; Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed dissolution specifications
- Published
- December 7, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 23155-490-01
by Heritage Pharmaceuticals Inc
- Reason
- Subpotent Drug
- Published
- December 7, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
- Published
- December 7, 2022
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
by Acella Pharmaceuticals, LLC
- Reason
- Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
- Published
- November 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
by Acella Pharmaceuticals, LLC
- Reason
- Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
- Published
- November 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Only, distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, NDC 62756-071-60
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Discoloration
- Published
- November 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Seed Ranch Flavor Co
- Product
- Everything But The Sushi & Dumplings, 5 fl. oz. (148 mL) gla…
- Reason
- Three sauces contain undeclared soy.
- Published
- November 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Seed Ranch Flavor Co
- Product
- Umami Everyday Savory Spice, 5 fl. oz. (148 mL) glass bottle…
- Reason
- Three sauces contain undeclared soy.
- Published
- November 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Seed Ranch Flavor Co
- Product
- Umami Everyday Sauce, 5 fl. oz. (148 mL) glass bottle, UPC 8…
- Reason
- Three sauces contain undeclared soy.
- Published
- November 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
G FUEL LLC
- Product
- GFUEL brand Watermelon Limeade Energy Drink; 16 fl. oz.; rea…
- Reason
- Product label does not declare the correct amount of caffeine.
- Published
- November 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO.
by Adam's Polishes LLC
- Reason
- CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO.
by Adam's Polishes LLC
- Reason
- Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross contamination due to product carry over.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross contamination due to product carry over.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
by Viatris Inc
- Reason
- Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
by ICU Medical Inc
- Reason
- Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01
by Par Formulations Private Limited
- Reason
- Failed Impurities/Degradation Specifications
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
by ImprimisRx NJ
- Reason
- Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
- Published
- November 23, 2022
- 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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