FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
C.H. Guenther & Son LLC
- Product
- 365 Whole Foods Market Small Bites Macaroni & Cheese. Net W…
- Reason
- Undeclared allergen (eggs) and pork
- Published
- April 16, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Truck Farm, LLC
- Product
- Desert Farms Jalapeno Mustard. Caution to refrigerate after…
- Reason
- The product is in violation for not having an approved filed process and for not having monitoring records.
- Published
- April 16, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
MTN OPS, LLC
- Product
- MTN OPS MULTI-V Men's Daily Multivitamin dietary supplement,…
- Reason
- Undeclared soy flour
- Published
- April 16, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
- Published
- April 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.
by Breckenridge Pharmaceutical, Inc.
- Reason
- CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
- Published
- April 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-294-21, Unit Dose NDC 60687-294-11.
by Amerisource Health Services LLC
- Reason
- cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.
- Published
- April 9, 2025
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13
by BIOCON PHARMA INC
- Reason
- Failed dissolution specifications: lower than specifications
- Published
- April 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
- Published
- April 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FRUSELVA USA
- Product
- Good & Gather baby Pea, Zucchini, Kale & Thyme Vegetable Pur…
- Reason
- elevated level of lead
- Published
- April 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Seabear Company
- Product
- SeaBear Smokedhouse Alehouse Clam Chowder is packaged in ret…
- Reason
- Recall was initiated due to potential failure of the seal and potential to be contaminated with Clostridium botulinum.
- Published
- April 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Seabear Company
- Product
- SeaBear Smokedhouse Salmon Chowder is packaged in flexible r…
- Reason
- Recall was initiated due to potential failure of the seal and potential to be contaminated with Clostridium botulinum.
- Published
- April 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Nestle-USA, Inc. (Corporate Office)
- Product
- Lean Cuisine Spinach Artichoke Ravioli, NET WT 9 OZ (255g),…
- Reason
- Potential foreign material (wood-like material)
- Published
- April 9, 2025
- Distribution
- Distributors and retailers in the follow…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Nestle-USA, Inc. (Corporate Office)
- Product
- Lean Cuisine Butternut Squash Ravioli, NET WT 9 7/8 OZ (280g…
- Reason
- Potential foreign material (wood-like material)
- Published
- April 9, 2025
- Distribution
- Distributors and retailers in the follow…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Nestle-USA, Inc. (Corporate Office)
- Product
- Lean Cuisine Lemon Garlic Shrimp Stir Fry, NET WT 10 OZ (283…
- Reason
- Potential foreign material (wood-like material)
- Published
- April 9, 2025
- Distribution
- Distributors and retailers in the follow…
View recall →
FDA Recall
Ongoing
Historical recordClass II
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4
by Exela Pharma Sciences LLC
- Reason
- Lack of Assurance of Sterility
- Published
- April 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 kettle style Neti Pot, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00102 7
by Ascent Consumer Products Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
- Published
- April 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg) for Nasal Wash System, 60-count All Natural USP Grade Saline Packets, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00103 4
by Ascent Consumer Products Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
- Published
- April 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP 700 mg and sodium chloride USP 2300 mg), 30-count All Natural USP Grade Saline Packets and 1 Soft tip Squeeze Bottle, Net WT 0.1OZ (3g) each, Distributed by Ascent Consumer Products Inc., Melville, NY 11747, UPC 6 46011 00104 1
by Ascent Consumer Products Inc.
- Reason
- Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
- Published
- April 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada.
by Johnson, S C and Son, Inc
- Reason
- Failed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
- Published
- April 2, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75
by QuVa Pharma, Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- April 2, 2025
- 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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