FDA Recall
Ongoing2026 recordClass II
Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
by American Regent, Inc.
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Published
- August 26, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
by American Regent, Inc.
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Published
- August 26, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967.
by American Regent, Inc.
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Published
- August 26, 2026
- Distribution
- Nationwide
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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
View recall →
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,…
View recall →
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,…
View recall →
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
View recall →
FDA Recall
🇺🇸 United States
Ongoing2026 recordClass I
Taylor Farms de Mexico S. de R.L. de C.V.
- Product
- TAYLOR FARMS BLEND LETT/ROM BLEND WITH BAG 4/5# Iceberg, Rom…
- Reason
- Potential Cyclospora contamination.
- Published
- August 19, 2026
- Distribution
- Domestic: AL, AR, CT, FL, GA, IA, IL, IN…
View recall →
FDA Recall
🇺🇸 United States
Ongoing2026 recordClass I
Taylor Farms de Mexico S. de R.L. de C.V.
- Product
- MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg, R…
- Reason
- Potential Cyclospora contamination.
- Published
- August 19, 2026
- Distribution
- Domestic: AL, AR, CT, FL, GA, IA, IL, IN…
View recall →
FDA Recall
🇺🇸 United States
Ongoing2026 recordClass I
Taylor Farms de Mexico S. de R.L. de C.V.
- Product
- Cross Valley Farms BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5…
- Reason
- Potential Cyclospora contamination.
- Published
- August 19, 2026
- Distribution
- Domestic: AL, AR, CT, FL, GA, IA, IL, IN…
View recall →
FDA Recall
🇺🇸 United States
Ongoing2026 recordClass I
Taylor Farms de Mexico S. de R.L. de C.V.
- Product
- TAYLOR FARMS LETTUCE SALAD W/BAG 4/5# Iceberg, Carrots, Red…
- Reason
- Potential Cyclospora contamination.
- Published
- August 19, 2026
- Distribution
- Domestic: AL, AR, CT, FL, GA, IA, IL, IN…
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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