FDA Recall
OngoingHistorical recordClass II
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-61
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
- Published
- October 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
- Published
- October 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)00309047131617
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
- Published
- October 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61, UPC (01)00309047130610
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
- Published
- October 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UPC (01)00309047130061
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
- Published
- October 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
OngoingHistorical recordClass II
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540. NDC: 43598-666-25
by Dr. Reddy's Laboratories, Inc.
- Reason
- Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
- Published
- October 15, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28
by AvKARE
- Reason
- Failed Content Uniformity Specifications
- Published
- October 15, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
- Published
- October 15, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by: AFCO, 550 Development Avenue, Chambersburg, PA 17201, Toll Free: 800-345-1329, Package Configuration: a) 4x1 Gallon Case, 5 Gallon Pail, 55 Gallon Drum.
by Acuity Specialty Products, Inc.
- Reason
- cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
- Published
- October 15, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum.
by Acuity Specialty Products, Inc.
- Reason
- cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
- Published
- October 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: January 5, 2026Historical recordClass II
Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsourcing LLC, Lowellville, OH 44436.
by RC Outsourcing, LLC
- Reason
- Lack of assurance of sterility.
- Published
- October 15, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2026Historical recordClass II
Eden¿¿¿s Elixirs, LLC
- Product
- Lifted Made-Lemon, Chewable tablet. 20mg 7OH/550mg Tablet-no…
- Reason
- Undeclared Yellow #5
- Published
- October 15, 2025
- Distribution
- Distributed in Texas.
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass I
Nate's Fine Foods, LLC
- Product
- TAYLOR FARMS COOKED FARFALLE MAP 8 X 3 lb pouches Net Weight…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass I
Nate's Fine Foods, LLC
- Product
- FRESH CREATIVE FOODS COOKED FARFALLE PASTA 8 x 3 lb pouches…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 31, 2026Historical recordClass II
Toto Foods, Inc.
- Product
- Toto S'Mores Ooey Gooey Cookie; Gluten Free & Dairy Free; Ne…
- Reason
- Product label contains conflicting statements about inclusion and being free of Soy ingredient.
- Published
- October 15, 2025
- Distribution
- Product was distributed to 6 different r…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 23, 2025Historical recordClass I
Harris Teeter
- Product
- Harris Teeter CINNAMON TEXAS TOAST, NET WT 5.0oz (0.31g), IN…
- Reason
- Undeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and therefore the allergen milk was not listed in the contain statement.
- Published
- October 15, 2025
- Distribution
- Product was sold in the following states…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2026Historical recordClass II
Eden¿¿¿s Elixirs, LLC
- Product
- Lifted Made Mint flavored tablets 20mg 7OH/550mg Tablet- Lif…
- Reason
- Undeclared Yellow #5
- Published
- October 15, 2025
- Distribution
- Distributed in Texas.
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: May 15, 2026Historical recordClass II
Eden¿¿¿s Elixirs, LLC
- Product
- Eskay Brands Mint flavored tablets. 40mg 7OH/550mg Tablet- E…
- Reason
- Undeclared Yellow #5
- Published
- October 15, 2025
- Distribution
- Distributed in Texas.
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass I
Nate's Fine Foods, LLC
- Product
- COOKED FETTUCCINE PASTA 6 X 5 lbs pouches Net Weight: 30 lbs…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- October 15, 2025
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
OngoingHistorical recordClass I
Nate's Fine Foods, LLC
- Product
- TAYLOR FARMS COOKED TROTOLLE MAP 8 X 2.75 lb pouches Net Wei…
- Reason
- Potential contamination with Listeria monocytogenes.
- Published
- October 15, 2025
- Distribution
- Multiple states
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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