FDA Recall
Ongoing
Historical recordClass II
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 - IVORY b) NDC: 69949-156-01, UPC: 854245006224 - NUDE c) NDC: 69949-152-01, UPC: 854245006187 - BUFF d) NDC: 69949-153-01, UPC: 854245006194 - SAND e) NDC: 69949-155-01, UPC: 854245006217 - BRONZE f) NDC: 69949-157-01, UPC: 854245006446 - MOCHA
by SYNCHRONICITY SPA INC, DBA SUNTE
- Reason
- CGMP Deviations
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
by SYNCHRONICITY SPA INC, DBA SUNTE
- Reason
- Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01
by Baxter Healthcare Corporation
- Reason
- Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
fgf brands, inc
- Product
- Bakeshop Chocolate Chip Muffin 4 count, in clear plastic cla…
- Reason
- Undeclared Walnut
- Published
- July 17, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
C. Krueger Finest Baked Goods
- Product
- C. Kreuger Gluten Free Peanut Butter Cookies, 2oz in plastic…
- Reason
- No ingredient statement on the label.
- Published
- July 17, 2024
- Distribution
- Alabama, Alaska, Arizona, Arkansas, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
C. Krueger Finest Baked Goods
- Product
- C. Kreuger Gluten Free White Chocolate Cherry Oatmeal Cookie…
- Reason
- No ingredient statement on the label.
- Published
- July 17, 2024
- Distribution
- Alabama, Alaska, Arizona, Arkansas, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Productos La Hacienda LLC
- Product
- Queso Rico La Hacienda brand queso fresco cheese packaged in…
- Reason
- Queso fresco was found to contain Listeria monocytogenes.
- Published
- July 17, 2024
- Distribution
- The product in question was distributed…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dairy Manufacturers, Inc
- Product
- Farmalac 0-12 Low lactose powdered infant formula with iron…
- Reason
- The firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards.
- Published
- July 17, 2024
- Distribution
- Throughout Texas
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dairy Manufacturers, Inc
- Product
- Crecelac Infant 0-12 powdered infant formula with iron 12.4…
- Reason
- The firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards. Cronobacter spp. detected by FDA sampling.
- Published
- July 17, 2024
- Distribution
- Throughout Texas
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Dairy Manufacturers, Inc
- Product
- Farmalac powdered infant formula with iron 12.4 oz cans
- Reason
- The firm has not submitted the required premarket notification, parents and caregivers should understand that the products have not been evaluated to determine whether they meet U.S. food safety and nutritional standards.
- Published
- July 17, 2024
- Distribution
- Throughout Texas
View recall →
FDA Recall
Ongoing
Historical recordClass I
To the Moon Capsules, Horny Goat Weed, 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
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 →
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.
Read the full medical disclaimer.