FDA Recall
Ongoing2026 recordClass I
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11
by Fresenius Kabi USA, LLC
- Reason
- Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
- Published
- August 26, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.
by MYLAN PHARMACEUTICALS INC
- Reason
- Failed Dissolution Specifications
- Published
- August 26, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Marketed by: GSMS, Incorporated, Camarillo, CA 93012 USA
by Golden State Medical Supply Inc.
- Reason
- CGMP deviations: tablets with black specks.
- Published
- August 26, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
- Published
- August 26, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01
by Regeneron Pharmaceuticals Inc
- Reason
- Lack of Assurance of Sterility
- Published
- August 26, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1
by Shilpa Medicare Limited
- Reason
- Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
- Published
- August 26, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1
by Shilpa Medicare Limited
- Reason
- Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
- Published
- August 26, 2026
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Ongoing2026 recordClass I
Coast Citrus Distributors
- Product
- Jalapeno Pepper packaged in bulk generic Coast Tropical card…
- Reason
- Potential Salmonella Javiana contamination
- Published
- August 26, 2026
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Ongoing2026 recordClass III
Prospector Popcorn, LLC
- Product
- Prospector Popcorn Belgian Chocolate Toffee Gourmet Popcorn…
- Reason
- Inaccurately declared nutrients including Iron (understated), and Vitamin D (overstated).
- Published
- August 26, 2026
- Distribution
- AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,…
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FDA Recall
🇺🇸 United States
Ongoing2026 recordClass III
Prospector Popcorn, LLC
- Product
- Prospector Popcorn Fudge Brownie Gourmet Popcorn 1.5oz and 3…
- Reason
- Inaccurately declared nutrients including Potassium (overstated) and Calcium (overstated).
- Published
- August 26, 2026
- Distribution
- AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,…
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FDA Recall
🇺🇸 United States
Ongoing2026 recordClass III
Prospector Popcorn, LLC
- Product
- Prospector Popcorn Maple Walnut Ice Cream Gourmet Popcorn 3.…
- Reason
- Inaccurately declared nutrients including Potassium (overstated), Calcium (overstated), and Iron (understated).
- Published
- August 26, 2026
- Distribution
- AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,…
View recall →
FDA Recall
🇺🇸 United States
Ongoing2026 recordClass II
Prospector Popcorn, LLC
- Product
- Prospector Popcorn Chocolate Mocha Gourmet Popcorn 1.5 oz.
- Reason
- Inaccurately declared nutrients including Carbohydrates (understated) and Cholesterol (understated).
- Published
- August 26, 2026
- Distribution
- AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL,…
View recall →
FDA Recall
Ongoing2026 recordClass I
Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-3508-41.
by Baxter Healthcare Corporation
- Reason
- Presence of Particulate Matter
- Published
- August 19, 2026
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Ongoing2026 recordClass I
529 COMMERCE, LLC
- Product
- Aquafaba Powder, Vegan Replacement, NET WT. 4 oz (113g) and…
- Reason
- Undeclared Egg
- Published
- August 19, 2026
- Distribution
- Distributed to ID, FL, MI, MN, UT, OR, W…
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FDA Recall
Ongoing2026 recordClass I
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.
by Liebel-Flarsheim Company LLC
- Reason
- Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
- Published
- August 19, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass I
Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.
by Victory Medical Center Pharmacy
- Reason
- Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
- Published
- August 19, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51
by Heritage Pharmaceuticals Inc
- Reason
- Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
- Published
- August 19, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3
by Prestige Brands Holdings
- Reason
- Lack of assurance of sterility. The recall is due to potential contamination
- Published
- August 19, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.
by Shoolin Pharma Chem LLP
- Reason
- CGMP Deviations:Noted during FDA inspection
- Published
- August 19, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08
by Shoolin Pharma Chem LLP
- Reason
- CGMP Deviations:Noted during FDA inspection
- Published
- August 19, 2026
- 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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