FDA Recall
Ongoing2026 recordClass II
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.
by Church & Dwight Co., Inc.
- Reason
- CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
- Published
- September 2, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed content uniformity specifications.
- Published
- September 2, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-458-15.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug
- Published
- September 2, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing2026 recordClass II
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug
- Published
- September 2, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug
- Published
- September 2, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug
- Published
- September 2, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug
- Published
- September 2, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-453-17.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug
- Published
- September 2, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug
- Published
- September 2, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug
- Published
- September 2, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-17.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug
- Published
- September 2, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-449-17.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug
- Published
- September 2, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug
- Published
- September 2, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17.
by ACCORD HEALTHCARE, INC.
- Reason
- Subpotent Drug
- Published
- September 2, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.
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
Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), 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
Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
by American Regent, Inc.
- Reason
- Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
- Published
- August 26, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing2026 recordClass II
Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) 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
Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), 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
ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), 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 →
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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