FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Acorn Raspberry Creme Filled Cookie found in gift basket: #…
- Reason
- Undeclared allergens; tree nuts
- Published
- December 20, 2023
- Distribution
- U.S. distribution to the following: AK,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Acorn Raspberry Creme Filled Cookie found in gift basket: #…
- Reason
- Undeclared allergens; tree nuts
- Published
- December 20, 2023
- Distribution
- U.S. distribution to the following: AK,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Acorn Raspberry Creme Filled Cookie found in gift basket: #…
- Reason
- Undeclared allergens; tree nuts
- Published
- December 20, 2023
- Distribution
- U.S. distribution to the following: AK,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Houdini Inc.
- Product
- Acorn Raspberry Creme Filled Cookie found in gift basket: #…
- Reason
- Undeclared allergens; tree nuts
- Published
- December 20, 2023
- Distribution
- U.S. distribution to the following: AK,…
View recall →
FDA Recall
Completed
Historical recordClass II
ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,
by STAQ Pharma, Inc.
- Reason
- STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.
- Published
- December 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25
by Baxter Healthcare Corporation
- Reason
- Failed pH Specifications
- Published
- December 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22
by Novartis Pharmaceuticals Corporation
- Reason
- Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
- Published
- December 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-096-02, UPC 850001805698.
by KINDER FARMS LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- December 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL), Distributed By: KinderFarms, Redondo Beach, CA 90277, NDC 82673-097-04, UPC 850001805728.
by KINDER FARMS LLC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- December 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe, 10/pack, Rx only, Carie Boyd Pharmaceuticals, 8400 Esters Blvd, Ste# 190, Irving, TX 75063, NDC73271-1003-1
by Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop
- Reason
- Product Mix-up: Incorrect Product Formulation
- Published
- December 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30
by Padagis US LLC
- Reason
- Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
- Published
- December 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL 34952.
by SUGARMDS LLC
- Reason
- MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
- Published
- December 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Dissolution Specifications
- Published
- December 13, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Sofia Produce, L.L.C.
- Product
- Whole cantaloupe, Brand name Rudy 11 count carton, 8 count c…
- Reason
- The affected product is being recalled from the marketplace due to possible Salmonella contamination.
- Published
- December 13, 2023
- Distribution
- Customers are located in the United Stat…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Sofia Produce, L.L.C.
- Product
- Whole cantaloupe, Brand name Malichita 11 count carton, 8 co…
- Reason
- The affected product is being recalled from the marketplace due to possible Salmonella contamination.
- Published
- December 13, 2023
- Distribution
- Customers are located in the United Stat…
View recall →
FDA Recall
Ongoing
Historical recordClass I
Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100 Guadalajara Jal, UPC 0736640810265
by Botanical Be
- Reason
- Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
- Published
- December 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos de Guadalupe, Zapopan Jal Mexico, UPC 7 502214 014598
by Botanical Be
- Reason
- Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
- Published
- December 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de Mexico, Melchol Ocampo # 65 Local D, Delegacion Xochimilco CP 16800, Mexico DF, UPC 7 501031 111138
by Botanical Be
- Reason
- Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
- Published
- December 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01
by Bayer Healthcare Pharmaceuticals Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
- Published
- December 6, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90; c)1000-count bottle, NDC 60429-737-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
by Golden State Medical Supply Inc.
- Reason
- Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
- Published
- December 6, 2023
- 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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