FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dole Fresh Vegetables
- Product
- Dole Colourful Coleslaw ( Salade Chou Coloree) - Canada Shr…
- Reason
- Complaints received of irregular pieces of soft plastic in the product.
- Published
- June 5, 2019
- Distribution
- US: AL, AZ, CA, CO, FL, IA, ID, IL, KS,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dole Fresh Vegetables
- Product
- Dole Classic Coleslaw (US) Shredded cabbage and carrots. 1…
- Reason
- Complaints received of irregular pieces of soft plastic in the product.
- Published
- June 5, 2019
- Distribution
- US: AL, AZ, CA, CO, FL, IA, ID, IL, KS,…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Oakhouse Bakery
- Product
- Specially Selected Paleo Granola, Grain Free. Maple Almond,…
- Reason
- Granola products may contain pieces of foreign material.
- Published
- June 5, 2019
- Distribution
- AR and CO
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Oakhouse Bakery
- Product
- GreenWise Cinnamon Peanut Butter Grain-Free Granola, Net Wt.…
- Reason
- Granola products may contain pieces of foreign material.
- Published
- June 5, 2019
- Distribution
- AR and CO
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Oakhouse Bakery
- Product
- GreenWise Cranberry Cashew Granola, Net Wt. 12 oz. (340g) Re…
- Reason
- Granola products may contain pieces of foreign material.
- Published
- June 5, 2019
- Distribution
- AR and CO
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Oakhouse Bakery
- Product
- purely elizabeth Pumpkin Spice + Ashwagandha Grain-Free Gran…
- Reason
- Granola products may contain pieces of foreign material.
- Published
- June 5, 2019
- Distribution
- AR and CO
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Oakhouse Bakery
- Product
- purely elizabeth Coconut Cashew Grain-Free Bar, Net Wt. 1.4…
- Reason
- Granola products may contain pieces of foreign material.
- Published
- June 5, 2019
- Distribution
- AR and CO
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Oakhouse Bakery
- Product
- purely elizabeth Peanut Butter Grain-Free Bar, Net Wt. 1.4 o…
- Reason
- Granola products may contain pieces of foreign material.
- Published
- June 5, 2019
- Distribution
- AR and CO
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Oakhouse Bakery
- Product
- purely elizabeth Chocolate Sea Salt Grain-Free Bar, Net Wt.…
- Reason
- Granola products may contain pieces of foreign material.
- Published
- June 5, 2019
- Distribution
- AR and CO
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Oakhouse Bakery
- Product
- purely elizabeth Banana Nut Butter Grain-Free Bar, Net Wt. 1…
- Reason
- Granola products may contain pieces of foreign material.
- Published
- June 5, 2019
- Distribution
- AR and CO
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Oakhouse Bakery
- Product
- purely elizabeth Banana Nut Butter Grain-Free Granola, Net W…
- Reason
- Granola products may contain pieces of foreign material.
- Published
- June 5, 2019
- Distribution
- AR and CO
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Oakhouse Bakery
- Product
- purely elizabeth Coconut Cashew Grain-Free Granola, packaged…
- Reason
- Granola products may contain pieces of foreign material.
- Published
- June 5, 2019
- Distribution
- AR and CO
View recall →
FDA Recall
Terminated
Historical recordClass I
Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ireland, NDC 0078-0972-61.
by Novartis Pharmaceuticals Corp.
- Reason
- Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
- Published
- May 29, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-601-16 Reorder #: 51116
by Septodont Inc.
- Reason
- Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.
- Published
- May 29, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60
by MALLINCKRODT PHARMACEUTICALS
- Reason
- Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
- Published
- May 29, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
by MALLINCKRODT PHARMACEUTICALS
- Reason
- Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
- Published
- May 29, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-644-09
by Heritage Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
- Published
- May 29, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-10
by Heritage Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
- Published
- May 29, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-09
by Heritage Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
- Published
- May 29, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-09
by Heritage Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
- Published
- May 29, 2019
- 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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