FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The SoyNut Butter Company
- Product
- I.M. Healthy, Unsweetened SoyNut Butter; Peanut Free; The So…
- Reason
- Potential contamination of product with E. coli O157.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The SoyNut Butter Company
- Product
- I.M. Healthy, Creamy SoyNut Butter; Peanut Free; The SoyNut…
- Reason
- Potential contamination of product with E. coli O157.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The SoyNut Butter Company
- Product
- Dixie Diners' Club Carb Not Beanit Butter, 15oz., Dixie USA,…
- Reason
- Potential contamination of product with E. coli O157.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The SoyNut Butter Company
- Product
- I.M. Healthy Raisin & Cranberry Granola; Peanut Free; The So…
- Reason
- Potential contamination of product with E. coli O157.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The SoyNut Butter Company
- Product
- I.M. Healthy, Original Granola; Peanut Free; The SoyNut butt…
- Reason
- Potential contamination of product with E. coli O157.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
The SoyNut Butter Company
- Product
- I.M. Healthy, Chunky SoyNut Butter; Peanut Free; The SoyNut…
- Reason
- Potential contamination of product with E. coli O157.
- Published
- April 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Baltimore, MD --- NDC 68180-556-09
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications; Impurity A
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-352-60
by Dr. Reddy's Laboratories, Inc.
- Reason
- Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-0272-05
by Fresenius Kabi USA, LLC
- Reason
- Subpotent Drug
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
XtraHRD Natural Male Enhancement Capsules, Herbal Dietary Supplement, 500 mg capsules, 2, 4 and 10 count boxes, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV 89503, UPC 680474228768
by Organic Herbal Supply
- Reason
- Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED).
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0918-40
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0929-40
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume 515 mL For IV Use Only, Rx Only , SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0925-44
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0924-59
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0923-59
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0920-59
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0922-40
by SCA Pharmaceuticals
- Reason
- Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydrochloride 10gm vials due to presence of particulate matter.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package - Not For Direct Infusion, For Intravenous Use, packaged in 100 mL glass vial, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6510-01
by Hospira Inc., A Pfizer Company
- Reason
- Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
by X-Gen Pharmaceuticals Inc.
- Reason
- Presence of Particulate Matter
- Published
- April 12, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080.
by G & W Laboratories, Inc.
- Reason
- Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
- Published
- April 12, 2017
- 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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