FDA Recall
Terminated
Historical recordClass III
oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for Institutional or Office Use Only, Not for Resale, QuVa PHARMA 519 Route 173, Bloomsbury, NJ 08804, Total volume: 500 mL bag, NDC: 70092-1068-07.
by QuVa Pharma, Inc.
- Reason
- Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
by Novartis Pharmaceuticals Corporation
- Reason
- CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 x 2 g vials per carton NDC 67457-352-10, Rx only, Mylan Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103 U.S.A
by Viatris Inc
- Reason
- Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Superpotent Drug: Out of specification for assay at the 12-month timepoint.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Superpotent Drug: Out of specification for assay at the 12-month timepoint.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
World Variety Produce Inc dba Melissa's
- Product
- Dutch Red Potatoes with Dijon Mustard Sauce. NET WT. 1 LB 1…
- Reason
- Dutch Red Potatoes were packed with a Dijon Mustard Sauce packet that did not declare the allergen of egg.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lamb Weston Sales
- Product
- Item SP204, Sprouts Organic Hash Browns Shredded Potatoes, 1…
- Reason
- Potential to be contaminated with Listeria monocytogenes.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lamb Weston Sales
- Product
- Item GV020, Great Value Shredded Hash Browns, 4 lbs. bag, 6/…
- Reason
- Potential to be contaminated with Listeria monocytogenes.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Lamb Weston Sales
- Product
- Item AX058, Alexia Organic Seasoned Hashed Browns Yukon Sele…
- Reason
- Potential to be contaminated with Listeria monocytogenes.
- Published
- October 5, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01
by UNICHEM PHARMACEUTICALS USA INC
- Reason
- Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
- Published
- September 28, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
J & N Nut Products Inc.
- Product
- Sliced Peanuts 25 LBS. NET WEIGHT Store away from heat Cold…
- Reason
- FDA sampling revealed allergen cross contamination. Almond protein in sliced peanuts and Peanut protein in sliced almonds.
- Published
- September 28, 2022
- Distribution
- U.S. distribution to the following: CA.…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
J & N Nut Products Inc.
- Product
- Golden Pacific California Shelled Almonds Sliced Almonds 25…
- Reason
- FDA sampling revealed allergen cross contamination. Almond protein in sliced peanuts and Peanut protein in sliced almonds.
- Published
- September 28, 2022
- Distribution
- U.S. distribution to the following: CA.…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
That's it. Nutrition, LCC
- Product
- That's It. Dark Chocolate Fig with Sea Salt Truffles Net WT…
- Reason
- CFIA testing of the products revealed casein and whey which caused undeclared milk in the products.
- Published
- September 28, 2022
- Distribution
- U.S. distribution to the following: CO,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
That's it. Nutrition, LCC
- Product
- That's It. Dark Chocolate Date Truffles Net WT. 3.5 oz, 5.0…
- Reason
- CFIA testing of the products revealed casein and whey which caused undeclared milk in the products.
- Published
- September 28, 2022
- Distribution
- U.S. distribution to the following: CO,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
That's it. Nutrition, LCC
- Product
- That's It. Dark Chocolate Fig Truffles Net WT. 3.5 oz, 5.0 o…
- Reason
- CFIA testing of the products revealed casein and whey which caused undeclared milk in the products.
- Published
- September 28, 2022
- Distribution
- U.S. distribution to the following: CO,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
That's it. Nutrition, LCC
- Product
- That's It. Dark Chocolate Raisin Truffles Net WT. 3.5 oz, 5.…
- Reason
- CFIA testing of the products revealed casein and whey which caused undeclared milk in the products.
- Published
- September 28, 2022
- Distribution
- U.S. distribution to the following: CO,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
That's it. Nutrition, LCC
- Product
- That's It. Dark Chocolate Banana Truffles Net WT. 3.5 oz, 5.…
- Reason
- CFIA testing of the products revealed casein and whey which caused undeclared milk in the products.
- Published
- September 28, 2022
- Distribution
- U.S. distribution to the following: CO,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Pepsico Inc
- Product
- Mountain Dew Major Melon Zero, 12 FL OZ (355mL) can, sold as…
- Reason
- The outer wraps match the liquid in the can (Zero Sugar - Mountain Dew Major Melon) however the primary package (can) is incorrect (Full Sugar Mountain Dew Major Melon). Product inside can matches the product/nutritional panel on the point-of-sale outer container wrap.
- Published
- September 28, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
by Pfizer Inc.
- Reason
- Presence of particulate matter
- Published
- September 21, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02.
by Teva Pharmaceuticals USA Inc
- Reason
- Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
- Published
- September 21, 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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