FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Dr. Praeger's Sensible Foods Inc.
- Product
- Dr. Praeger s California Veggie Fries 8oz,
- Reason
- Undeclared Allergen (Soy)
- Published
- April 16, 2025
- Distribution
- The adulterated product was distributed…
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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
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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
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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
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FDA Recall
Ongoing
Historical recordClass III
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.
by Imprimis NJOF, LLC
- Reason
- Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
- Published
- April 9, 2025
- Distribution
- FL and NY
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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
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Barry Callebaut USA LLC
- Product
- CACAO BARRY Gianduja Noir, 5.5lbs (2.5kg) plastic bucket, 8…
- Reason
- Undeclared milk
- Published
- April 9, 2025
- Distribution
- Multiple states
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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
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Coastal Companies DBA Hearn Kirkwood
- Product
- Turkey BLT on Sourdough Net Wt. 8.94 OZ (253g) in plastic cl…
- Reason
- Turkey BLT on Sourdough Sandwiches being recalled due to the product having the incorrect sandwich (Peanut Butter & Jelly) in the clamshell container. This incorrect product in the container resulted in an undeclared allergen on the product label (peanuts).
- Published
- April 9, 2025
- Distribution
- New York
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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
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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
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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…
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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…
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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…
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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
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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
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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
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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
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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 →
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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