FDA Recall
Terminated
Historical recordClass II
Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11
by Shandex Personal Care Manufacturing Inc.
- Reason
- Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
- Published
- February 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704
by McGuff Compounding Pharmacy Services, Inc.
- Reason
- Presence of Particulate Matter: Particulates observed in vials release for dispensing.
- Published
- February 5, 2020
- Distribution
- Prescriptions filled for patients in the…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Jeni's Splendid Ice Creams LLC
- Product
- Jeni's Dairy Free Cold Brew with Coconut Cream Pints frozen…
- Reason
- May contain undeclared milk allergen
- Published
- February 5, 2020
- Distribution
- Product distributed to the following sta…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- 365 Everyday Value Dark Chocolate Caramel Sea Salt Sandwich…
- Reason
- Potential to contain undeclared milk and coconut.
- Published
- February 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- 365 Everyday Value Dark Chocolate Peppermint Sandwich Cremes…
- Reason
- Potential to contain undeclared milk.
- Published
- February 5, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.
by Hikma Pharmaceuticals USA Inc.
- Reason
- Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
- Published
- January 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
by Tuscano and Delucia Group (DBA Entropic Labs)
- Reason
- Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
- Published
- January 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.
by Advanced Accelerator Applications USA, Inc.
- Reason
- Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
- Published
- January 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)
by Preferred Pharmaceuticals, Inc
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- January 29, 2020
- Distribution
- Distribution to physicians in the follow…
View recall →
FDA Recall
Terminated
Historical recordClass II
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)
by Preferred Pharmaceuticals, Inc
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- January 29, 2020
- Distribution
- Distribution to physicians in the follow…
View recall →
FDA Recall
Terminated
Historical recordClass II
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
by Denton Pharma, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- January 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.
by Denton Pharma, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- January 29, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-60
by H J Harkins Company Inc dba Pharma Pac
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- January 29, 2020
- Distribution
- Distributed to Physicians in the followi…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Savannah Food Company, Inc.
- Product
- Piccadilly Cornbread Dressing in 2# trays
- Reason
- Eggs used in the manufacture of the products may be contaminated with listeria monocytogenes
- Published
- January 29, 2020
- Distribution
- Products distributed to the following st…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Savannah Food Company, Inc.
- Product
- Savannah Classics Classic Bread Stuffing packaged in 4.5lb t…
- Reason
- Eggs used in the manufacture of the products may be contaminated with listeria monocytogenes
- Published
- January 29, 2020
- Distribution
- Products distributed to the following st…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Savannah Food Company, Inc.
- Product
- Savannah Classics Classic Cornbread Dressing packaged in 7lb…
- Reason
- Eggs used in the manufacture of the products may be contaminated with listeria monocytogenes
- Published
- January 29, 2020
- Distribution
- Products distributed to the following st…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Savannah Food Company, Inc.
- Product
- Savannah Classics Special Cornbread Dressing packaged in 7lb…
- Reason
- Eggs used in the manufacture of the products may be contaminated with listeria monocytogenes
- Published
- January 29, 2020
- Distribution
- Products distributed to the following st…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Savannah Food Company, Inc.
- Product
- Morrison's cornbread dressing packaged in 7lb trays
- Reason
- Eggs used in the manufacture of the products may be contaminated with listeria monocytogenes
- Published
- January 29, 2020
- Distribution
- Products distributed to the following st…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Savannah Food Company, Inc.
- Product
- Morrison's cornbread dressing packaged in 4lb tray
- Reason
- Eggs used in the manufacture of the products may be contaminated with listeria monocytogenes
- Published
- January 29, 2020
- Distribution
- Products distributed to the following st…
View recall →
FDA Recall
Terminated
Historical recordClass I
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose Vials (NDC 0641-6042-01), 25 vials/shelf-pack (NDC 0641-6042-25), For IV or IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
by Hikma Pharmaceuticals USA Inc.
- Reason
- Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
- Published
- January 22, 2020
- 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.