FDA Recall
Terminated
Historical recordClass III
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
by Imprimis NJOF, LLC
- Reason
- Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
HEINZ
- Product
- Kraft Singles American Pasteurized Prepared Cheese product,…
- Reason
- Plastic fragment. Product is recalled due to potential for a thin strip of the primary packaging film to remain adhered to the cheese slice after the wrapper has been removed.
- Published
- October 25, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Safeway Fresh Foods LLC
- Product
- Sunnyside Farms, diced Organic Butternut Squash , 32-oz. , p…
- Reason
- Safeway Fresh Foods of Vineland, NJ, is recalling its 32-oz. Diced Organic Butternut Squash product as it has the potential to be contaminated with Escherichia coli O45. The 32-oz. diced Butternut was distributed only to Costco in the following states, Washington DC, Maryland, Pennsylvania, and Virgnia.
- Published
- October 25, 2023
- Distribution
- The product was distributed to the follo…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Sheng Kee of California, Inc dba Sheng Kee Bakery
- Product
- Large 4- Red Bean Mooncake Gift Box
- Reason
- Undeclared allergen; egg.
- Published
- October 25, 2023
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Sheng Kee of California, Inc dba Sheng Kee Bakery
- Product
- Large 4- Lotus Pine Nut Mooncake Gift Box
- Reason
- Undeclared allergen; egg.
- Published
- October 25, 2023
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Sheng Kee of California, Inc dba Sheng Kee Bakery
- Product
- Small 12- Tea Flavor Assorted Mooncake Gift Box
- Reason
- Undeclared allergen; egg.
- Published
- October 25, 2023
- Distribution
- U.S. distribution to the following: CA,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Sheng Kee of California, Inc dba Sheng Kee Bakery
- Product
- Large 4- Date Mooncake Gift Box
- Reason
- Undeclared allergen; egg.
- Published
- October 25, 2023
- Distribution
- U.S. distribution to the following: CA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Sheng Kee of California, Inc dba Sheng Kee Bakery
- Product
- Small 12 -3 Flavor Assorted Mooncake Gift Box Small 12- 4 Fl…
- Reason
- Undeclared allergen; egg.
- Published
- October 25, 2023
- Distribution
- U.S. distribution to the following: CA,…
View recall →
FDA Recall
Completed
Historical recordClass I
BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04
by Scynexis, Inc.
- Reason
- Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
- Published
- October 18, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Infinant Health, LLC
- Product
- Evivo with MCT Oil Infant Probiotic Activated B. infantis EV…
- Reason
- Unapproved food additive.
- Published
- October 18, 2023
- Distribution
- U.S. Distribution to the following: TX,…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fairfield Gourmet Food Corp d/b/a David's Cookies
- Product
- Markside Ultimate Peanut Butter Chocolate Cake, 7 oz.(198g),…
- Reason
- Fairfield Gourmet Food Corp. d/b/a David s Cookies ,28 Industrial Road, Fairfield NJ 07004has initiated a recall of Markside Ultimate Peanut Butter Chocolate Cake, 7 oz.(198g) plastic package (i.e.) Clamp shell 8 package per case, LOT # BS23212 (Manufactured on July, 31, 2023) because of MISLABELED / UNDECLARED ALLERGENS (Peanuts)
- Published
- October 18, 2023
- Distribution
- The recall product was distributed to th…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Little Oak Company Ltd
- Product
- LittleOak Natural Goat Milk Follow On Infant Formula (Stage…
- Reason
- No pre-market notification and Mixing instructions not in ounces
- Published
- October 18, 2023
- Distribution
- WY, CA, NY, GA, IL, UT, MD, CO, PA, VT,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Little Oak Company Ltd
- Product
- LittleOak Natural Goat Milk Infant Formula (Stage 1); packag…
- Reason
- No pre-market notification and Mixing instructions not in ounces
- Published
- October 18, 2023
- Distribution
- WY, CA, NY, GA, IL, UT, MD, CO, PA, VT,…
View recall →
FDA Recall
Ongoing
Historical recordClass II
Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intra-articular use only, Shake Well, Not for IV/ID, intraocular, epidural, or intrathecal use, Mfd. in India for Auromedics Pharma LLC., E Windsor, NJ, 08520, NDC 55150-385-01.
by Eugia US LLC
- Reason
- Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979
by Imprimis NJOF, LLC
- Reason
- Subpotent: Failing Test Results for Epinephrine
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11
by Amerisource Health Services LLC
- Reason
- Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Dissolution Specifications
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001111.
by Dr. Berne's Whole Health Products
- Reason
- Non-Sterility
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001111.
by Dr. Berne's Whole Health Products
- Reason
- CGMP Deviations
- Published
- October 11, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, Certified Organic by Organic Certifiers.
by Dr. Berne's Whole Health Products
- Reason
- CGMP Deviations
- Published
- October 11, 2023
- 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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