FDA Recall
Terminated
Historical recordClass II
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 18 mcg/1.8mg/0.2mg/0.02mg/mL, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0547-2
by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
- Reason
- Lack of Assurance of Sterility
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22.
by Teva Pharmaceuticals USA
- Reason
- Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Choice Products LLC.
- Product
- Premiere Choice 3lb. Peanut Butter Cookie Dough, item 412, N…
- Reason
- Peanut Butter Cookie Dough may contain undeclared milk.
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Custom Foods LLC
- Product
- Sticky Fingers Bakeries Gluten-Free Scones, Quick & Easy Mix…
- Reason
- Firm received customer inquiry of why wheat is listed in the ingredient list of a product that is "Gluten Free".
- Published
- March 11, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Cj Haide (Ningbo) Biotech Co., Ltd
- Product
- Aminature L-Cysteine HCl Anhydrous 100 mesh 25KG DRUM
- Reason
- Foreign material, metal
- Published
- March 11, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Driscoll's Inc.
- Product
- Driscoll's Raspberries- 6 oz. clamshell container 12 x 6 oz…
- Reason
- In House testing found a residue of 0.927 ppm of Zeta-cypermethrin on raspberries, which is above the U.S. MRL of 0.800 ppm
- Published
- March 11, 2020
- Distribution
- PA, KY, MA, MI. MD, FL, CO, MI, NC, NJ,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- Chocolate Dipped Coconut Macaroon Cookie sold by the individ…
- Reason
- Undeclared milk
- Published
- March 11, 2020
- Distribution
- Kentucky, Maryland, New Jersey, Pennsylv…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- Dark Chocolate Dipped Almond Horn Cookie sold by the individ…
- Reason
- Undeclared milk
- Published
- March 11, 2020
- Distribution
- Kentucky, Maryland, New Jersey, Pennsylv…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- Marble Bundt Cake sold by the slice packaged in Self Serve a…
- Reason
- Undeclared milk
- Published
- March 11, 2020
- Distribution
- Kentucky, Maryland, New Jersey, Pennsylv…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- Chocolate Fudge Mini Bundt Cake sold by the slice packaged i…
- Reason
- Undeclared milk
- Published
- March 11, 2020
- Distribution
- Kentucky, Maryland, New Jersey, Pennsylv…
View recall →
FDA Recall
Terminated
Historical recordClass III
Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98.
by Breckenridge Pharmaceutical, Inc
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.
- Published
- March 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A. Inc. Hawthorne, NY 10532, NDC 51672-4069-1
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
- Published
- March 4, 2020
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed By: CVS Pharmacy Inc. One CVS Drive, Woonsocket, RI 02895, NDC 59779-303-01
by Akorn, Inc.
- Reason
- Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
- Published
- March 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-9050-00.
by Akorn, Inc.
- Reason
- Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
- Published
- March 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-622-35
by Akorn, Inc.
- Reason
- Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identified as tin with trace copper, which are the base of the materials of construction for the tube.
- Published
- March 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012
by Golden State Medical Supply Inc.
- Reason
- Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
- Published
- March 4, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Paleonola Llc
- Product
- Paleonola Grain Free Granola; Pumpkin Pie; packaged in 10oz…
- Reason
- Potentially contaminated with an unapproved herbicide, haloxyfop.
- Published
- March 4, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Paleonola Llc
- Product
- Paleonola Grain Free Granola; Apple Pie; packaged in 10oz st…
- Reason
- Potentially contaminated with an unapproved herbicide, haloxyfop.
- Published
- March 4, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Paleonola Llc
- Product
- Paleonola Grain Free Granola; Chocolate Fix; packaged in 10o…
- Reason
- Potentially contaminated with an unapproved herbicide, haloxyfop.
- Published
- March 4, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Paleonola Llc
- Product
- Paleonola Grain Free Granola; Pina Colada; packaged in 10oz…
- Reason
- Potentially contaminated with an unapproved herbicide, haloxyfop.
- Published
- March 4, 2020
- Distribution
- Multiple states
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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