FDA Recall
Terminated
Historical recordClass III
Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
by Acella Pharmaceuticals, LLC
- Reason
- Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
- Published
- November 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Only, distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, NDC 62756-071-60
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Discoloration
- Published
- November 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Seed Ranch Flavor Co
- Product
- Everything But The Sushi & Dumplings, 5 fl. oz. (148 mL) gla…
- Reason
- Three sauces contain undeclared soy.
- Published
- November 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Seed Ranch Flavor Co
- Product
- Umami Everyday Savory Spice, 5 fl. oz. (148 mL) glass bottle…
- Reason
- Three sauces contain undeclared soy.
- Published
- November 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass I
Seed Ranch Flavor Co
- Product
- Umami Everyday Sauce, 5 fl. oz. (148 mL) glass bottle, UPC 8…
- Reason
- Three sauces contain undeclared soy.
- Published
- November 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
G FUEL LLC
- Product
- GFUEL brand Watermelon Limeade Energy Drink; 16 fl. oz.; rea…
- Reason
- Product label does not declare the correct amount of caffeine.
- Published
- November 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO.
by Adam's Polishes LLC
- Reason
- CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO.
by Adam's Polishes LLC
- Reason
- Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross contamination due to product carry over.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
by Nephron Sterile Compounding Center LLC
- Reason
- CGMP Deviations: Potential for cross contamination due to product carry over.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
by Viatris Inc
- Reason
- Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
by ICU Medical Inc
- Reason
- Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01
by Par Formulations Private Limited
- Reason
- Failed Impurities/Degradation Specifications
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
by ImprimisRx NJ
- Reason
- Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
- Published
- November 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton).
by Viatris Inc
- Reason
- Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
- Published
- November 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Hammond's Candies Since 1920 II, LLC
- Product
- Hammond's Salted Caramel Cookies, NET WT. 5 OZ (142g), UPC 6…
- Reason
- Peanut Butter Chocolate Chip Cookies mispacked in Salted Caramel Cookies Box creating undeclared peanut allergen.
- Published
- November 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990.
by Genentech Inc
- Reason
- Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
- Published
- November 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Presence of Foreign Substance
- Published
- November 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.
by Exela Pharma Sciences LLC
- Reason
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1
by Exela Pharma Sciences LLC
- Reason
- Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
- Published
- November 2, 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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