FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Enjoy Life Natural Brands, LLC
- Product
- Enjoy Life Soft Baked Cookies Monster, 6 oz. UPC 8195970…
- Reason
- Due to the potential presence of a foreign material (hard plastic pieces) in baked good products.
- Published
- August 31, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Enjoy Life Natural Brands, LLC
- Product
- Enjoy Life Soft Baked Cookies Sunseed Butter Chocolate C…
- Reason
- Due to the potential presence of a foreign material (hard plastic pieces) in baked good products.
- Published
- August 31, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Enjoy Life Natural Brands, LLC
- Product
- Enjoy Life Soft Baked Cookies Double Chocolate Brownie,…
- Reason
- Due to the potential presence of a foreign material (hard plastic pieces) in baked good products.
- Published
- August 31, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Enjoy Life Natural Brands, LLC
- Product
- Enjoy Life Soft Baked Cookies Chocolate Chip, 6 oz. (170…
- Reason
- Due to the potential presence of a foreign material (hard plastic pieces) in baked good products.
- Published
- August 31, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Enjoy Life Natural Brands, LLC
- Product
- Enjoy Life Soft Baked Cookies Snickerdoodle, 6 oz .(170g…
- Reason
- Due to the potential presence of a foreign material (hard plastic pieces) in baked good products.
- Published
- August 31, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
by Akorn, Inc
- Reason
- Defective Container: Product has incomplete induction seals.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
by Nephron Sc Inc
- Reason
- cGMP Deviations: deviations leading to potential cross-contamination.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Impurities/Degradation Specifications
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
by Amerisource Health Services LLC
- Reason
- Subpotent Drug
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60
by Baxter Healthcare Corporation
- Reason
- Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
by Lupin Pharmaceuticals Inc.
- Reason
- CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02
by HERON THERAPEUTICS, INC.
- Reason
- Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilbur's Of Maine Chocolate Confections
- Product
- Wilbur's of Maine Milk Chocolate Covered Blueberries
- Reason
- Product contains undeclared almonds.
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Crown Prince, Inc
- Product
- Crown Prince Quality Natural Seafood Smoked Baby Clams Hand…
- Reason
- Detectable levels of Per- and polyfluoroalkyl substances (PFAS).
- Published
- August 24, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
by SterRx, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- August 17, 2022
- 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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