FDA Recall
Ongoing
Historical recordClass I
RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
by Integrity Products
- Reason
- Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent drug: out of specification results
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
by Trigen Laboratories
- Reason
- Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 73673 88798 0, NDC 70722-319-04; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b) 3 OZ (85.05G) metal tin, UPC Code 6 73673 88208 4, NDC 70722-208-03; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673 88231 2, NDC 70722-229-05) b) 2OZ (57G) glass jar, UPC Code 6 73673 88220 6, NDC 70722-229-02; c) 4OZ (113G) glass jar, UPC Code 6 73673 88218 3, NDC 70722-229-04; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 73673 88233 6, NDC 70722-246-04; Little Moon Essentials LLC Dania Beach, Fl 33004
by Little Moon Essentials LLC
- Reason
- CGMP deviations
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
by Medisca Inc.
- Reason
- CGMP Deviations and Presence of Particulate Matter: Glass
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Casper's Ice Cream, Inc
- Product
- Red Button Vintage Creamery Cookie Dough Ice Cream, Net weig…
- Reason
- Foreign object, rubber, found in two tubs of Red Button Vintage Creamery Cookie Dough Ice Cream.
- Published
- July 10, 2024
- Distribution
- Product was distributed to the following…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Breadbox Co.
- Product
- Breadman Brioche products in plastic bags: Brioche Toast, 2…
- Reason
- Undeclared Yellow No. 5
- Published
- July 10, 2024
- Distribution
- No foreign or government consignees. The…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Breadbox Co.
- Product
- Breadman Raisin Bread, plastic bag, 16oz
- Reason
- Undeclared milk allergen and undeclared Yellow No. 5
- Published
- July 10, 2024
- Distribution
- No foreign or government consignees. The…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Breadbox Co.
- Product
- Breadman Jalapeno Cheese Bagels, plastic bag, 16oz
- Reason
- Undeclared milk allergen
- Published
- July 10, 2024
- Distribution
- No foreign or government consignees. The…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Grato Holdings, Inc.
- Product
- BioActive Nutritional MINAPLEX, Botanical Herbal Supplement;…
- Reason
- Potential microbial contamination (yeast and/or mold).
- Published
- July 10, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Grato Holdings, Inc.
- Product
- Energique Mineral Magic Dietary Supplement, 2 fl. oz (59 ml)…
- Reason
- Potential microbial contamination (yeast and/or mold).
- Published
- July 10, 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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