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…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Truong Phu Xanh Co.,
- Product
- Frozen Yellowfin Tuna, Product of Vietnam, Packaged under t…
- Reason
- Elevated histamine levels.
- Published
- February 5, 2020
- Distribution
- Direct Distribution to FL, RI, CA, NJ
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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…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Kindroot LLC
- Product
- kindroot adaptogems; Peach Blossom Plant lozenges for li…
- Reason
- Inspection by California Department of Public Health found that product label did not include fish as the source of collagen peptides.
- Published
- February 5, 2020
- Distribution
- CA NY, VA and 18 online sales on to cust…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ingredion Incorporated
- Product
- Ingredion ULTRA-TEX4 Food Starch in 50lb paper bags, product…
- Reason
- Foreign material. Potential for fragments of stainless steel wire in the product. Fragments are approximately 0.19mm in diameter with varying lengths of 1mm 20mm in length.
- Published
- February 5, 2020
- Distribution
- CA, GA, IL, MN, MO, NC, NJ, OH Australi…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Healthy Food Ingredients, LLC
- Product
- Organic IntegriPure Cold Milled Flaxseed, 50 lb Net Wt. and…
- Reason
- Product is being recalled due to detection of an unapproved herbicide.
- Published
- February 5, 2020
- Distribution
- CA, CO, UT. EXPANDED February 2020: M…
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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
🇺🇸 United States
Terminated
Historical recordClass II
H.L. Foodservice, Inc. dba H.L. Foods Co.
- Product
- Ground Ginger in clear plastic bags; Sold in 1 lb. and 5 lb…
- Reason
- Ground ginger does not properly identify addition of sulfites on the package label.
- Published
- February 5, 2020
- Distribution
- CA only
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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
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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
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FDA Recall
Terminated
Historical recordClass II
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
by RemedyRePack Inc.
- Reason
- CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
- Published
- January 29, 2020
- Distribution
- Product was distributed to two facilitie…
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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…
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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…
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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…
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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 →
FDA Recall
Terminated
Historical recordClass II
Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA 92704
by McGuff Compounding Pharmacy Services, Inc.
- Reason
- Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
- 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.
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