FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bea Lydeckers Naturals Inc
- Product
- Living Free Lung & Joint Congestion Herbal Dietary Supplemen…
- Reason
- Label declares lecithin but does not declare soy lecithin.
- Published
- July 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bea Lydeckers Naturals Inc
- Product
- Living Free Immune Dietary Supplement, 100 and 500 capsules…
- Reason
- Label declares lecithin but does not declare soy lecithin.
- Published
- July 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bea Lydeckers Naturals Inc
- Product
- Living Free Heart/Blood Vessel Dietary Supplement, 100 or 50…
- Reason
- Label declares lecithin but does not declare soy lecithin.
- Published
- July 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Bea Lydeckers Naturals Inc
- Product
- Living Free "Adult Extra" multi-vitamin, 100 or 500 capsules…
- Reason
- Label declares lecithin but does not declare soy lecithin.
- Published
- July 21, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71
by Teva Pharmaceuticals USA
- Reason
- Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
- Published
- July 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
by Fresenius Kabi USA LLC
- Reason
- Low out of specification results for epinephrine assay.
- Published
- July 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of France, Manufactured by: Genentech, Inc. A Member of the Roche Group, South San Francisco, CA 9480-4990. NDC: 50242-215-01
by Genentech Inc
- Reason
- Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
- Published
- July 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film, Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA, NDC 47781-355-03
by Alvogen, Inc
- Reason
- Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
- Published
- July 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Heritage Family Specialty Foods, Inc.
- Product
- E6164J2 Taco Casa Green Salsa 8 x 4 lb (1.8 kg) pouches
- Reason
- Potential to contain a foreign material
- Published
- July 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Heritage Family Specialty Foods, Inc.
- Product
- Hatch Verde Salsa Medium Net Wt. 12 oz (340g) 6 jars per cas…
- Reason
- Potential to contain a foreign material
- Published
- July 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by: Dibar Labs, LLC,.Sugar Land, TX 77479, Distributed by: Lifetime Health Services, Pharr, TX 78577, Made in Mexico, NDC; 79284-005-00. UPC 8 60004 06470 1
by DIBAR NUTRICIONAL S DE RL DE CV
- Reason
- CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002-01 and b) 16 FL OZ (473.2 mL), NDC 75408-002-02 bottles, Imported by: Dibar Labs, LLC., Sugar Land, TX 77479; Distributed by: PR Trading LLC, PO Box 19647, San Juan, PR 00910, Made in Mexico.
by DIBAR NUTRICIONAL S DE RL DE CV
- Reason
- CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.1 mL) bottle, NDC 73009-001-16, UPC 8 53090 00302 0 and b) 8 FL OZ (236.5 mL) bottle, NDC 73009-0001-08, UPC 8 53090 00301 3; Distributed by: S.E.N.D, LLC., Anthony, NM 88021; Imported by: Dibar Labs, LLC., Sugar Land, TX 77479, Made in Mexico.
by DIBAR NUTRICIONAL S DE RL DE CV
- Reason
- CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Imported by Dibar Labs, LLC, Sugar Land, TX 77479, Made in Mexico,77479, NDC 73009-0001-08 UPC 8 53090 00301 3.
by DIBAR NUTRICIONAL S DE RL DE CV
- Reason
- Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by HoYu (US) Logistics Inc UPC 6 926645 716288
by HOYU(US) LOGISTICS INC
- Reason
- Subpotent
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
by NSNY Distributor Inc
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra Vita Co, Santa Fe Springs, CA, Made in USA , UPC 0 40232 32555 7
by NSNY Distributor Inc
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cuisine Solutions
- Product
- JUST Egg Inspired by Japan Portobello, Mushrooms, Sweet Pota…
- Reason
- Undeclared egg and milk
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cuisine Solutions
- Product
- JUST Egg Inspired by India Curry, Broccoli, Cauliflower, Coc…
- Reason
- Undeclared egg and milk
- Published
- July 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cuisine Solutions
- Product
- JUST Egg Inspired by Mexico Roasted Poblanos, Ancho Chilli P…
- Reason
- Undeclared egg and milk
- Published
- July 7, 2021
- 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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