FDA Recall
Ongoing
Historical recordClass I
ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
by Boulla LLC
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
by Boulla LLC
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
by Boulla LLC
- Reason
- Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons).
by American Regent, Inc.
- Reason
- Presence of Particulate Matter: Potential for glass delamination from the vials.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).
by American Regent, Inc.
- Reason
- Presence of Particulate Matter: Potential for glass delamination from the vials.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).
by American Regent, Inc.
- Reason
- Presence of Particulate Matter: Potential for glass delamination from the vials.
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC 65862-833-30 90 mg - 500 Tablets - NDC 65862-833-05
by Aurobindo Pharma USA Inc
- Reason
- cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
by Aurobindo Pharma USA Inc
- Reason
- cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
by Aurobindo Pharma USA Inc
- Reason
- cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent drug
- Published
- December 11, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Albertsons Companies LLC
- Product
- (1) GINGER CHICKEN BROCCOLI SALAD FS (UPC 27110800000) (2) R…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- December 11, 2024
- Distribution
- AK, AZ, AR, CA, ID, IL, IN, IA, LA, ME,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Albertsons Companies LLC
- Product
- (1) READY MEALS CHICKEN STREET TACOS SS COLD (UPC 2713160000…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- December 11, 2024
- Distribution
- AK, AZ, AR, CA, ID, IL, IN, IA, LA, ME,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Albertsons Companies LLC
- Product
- (1) READY MEALS GREEN CHILI CHICKEN ENCHILADAS SS COLD (UPC…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- December 11, 2024
- Distribution
- AK, AZ, AR, CA, ID, IL, IN, IA, LA, ME,…
View recall →
FDA Recall
Terminated
Historical recordClass II
Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05
by JR Watkins
- Reason
- cGMP Deviations
- Published
- December 4, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 55758-039-01, UPC 8 59424 00433 6
by Unexo Life Sciences Private Limited
- Reason
- cGMP Deviations
- Published
- December 4, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9
by Unexo Life Sciences Private Limited
- Reason
- cGMP Deviations
- Published
- December 4, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5
by Unexo Life Sciences Private Limited
- Reason
- cGMP Deviations
- Published
- December 4, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Wellness, Inc., Beaverton, Oregon 97008-7105
by Unexo Life Sciences Private Limited
- Reason
- cGMP Deviations
- Published
- December 4, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%, Distributed by: Walmart Inc., Bentonville, AR 72716 NDC 79903-106-06
by Unexo Life Sciences Private Limited
- Reason
- cGMP Deviations
- Published
- December 4, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC 8 45717 01072 6
by Unexo Life Sciences Private Limited
- Reason
- cGMP Deviations
- Published
- December 4, 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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