FDA Recall
Terminated
Historical recordClass II
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories
by Amerisource Health Services LLC
- Reason
- Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.
- Published
- February 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL Sterile Multiple Use Vial, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.
by McGuff Compounding Pharmacy Services, Inc.
- Reason
- Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
- Published
- February 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Sterile Single Use Vial, Preservative-Free, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.
by McGuff Compounding Pharmacy Services, Inc.
- Reason
- Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
- Published
- February 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Pepsico Inc
- Product
- Starbucks frappuccino Vanilla. Chilled Coffee Drink. 13.7 F…
- Reason
- Foreign object (glass).
- Published
- February 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.
by BIOCON PHARMA INC
- Reason
- Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
- Published
- February 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02
by Akorn, Inc.
- Reason
- Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
- Published
- February 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.
by Urban Electric Power
- Reason
- CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
- Published
- February 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML) bottles, d)12 FL OZ (355 ML) bottles, e)16 FL OZ (473 ML) bottles, f) 64 FL OZ (1892 ML) bottles, g) 128 FL OZ (3785 ML) bottles
by Urban Electric Power
- Reason
- CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
- Published
- February 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Mondelez Global Llc
- Product
- Sour Patch Kids Watermelon Jelly Beans Net Wt.3 OZ (368g) UP…
- Reason
- Undeclared FD&C Yellow No. 5
- Published
- February 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ortho Molecular Products, Inc.
- Product
- Fiber Powder, Dietary Supplement, Apple Cinnamon Flavored, p…
- Reason
- Raw material tested positive for Cronobacter sakazakii.
- Published
- February 15, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 47335-679-81
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
- Published
- February 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2131
by GFA Production Xiamen Co. Ltd.
- Reason
- Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- Published
- February 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 2980-0700
by GFA Production Xiamen Co. Ltd.
- Reason
- Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- Published
- February 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2132
by GFA Production Xiamen Co. Ltd.
- Reason
- Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- Published
- February 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Easy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2150
by GFA Production Xiamen Co. Ltd.
- Reason
- Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- Published
- February 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2128
by GFA Production Xiamen Co. Ltd.
- Reason
- Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- Published
- February 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2129
by GFA Production Xiamen Co. Ltd.
- Reason
- Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- Published
- February 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0212
by GFA Production Xiamen Co. Ltd.
- Reason
- Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- Published
- February 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0213
by GFA Production Xiamen Co. Ltd.
- Reason
- Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- Published
- February 8, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Adventure Marine 150, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 1015-0150
by GFA Production Xiamen Co. Ltd.
- Reason
- Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- Published
- February 8, 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.
Read the full medical disclaimer.