FDA Recall
Ongoing
2026 recordClass II
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01
by SOMERSET THERAPEUTICS LLC
- Reason
- Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
- Published
- March 25, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing
2026 recordClass II
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
by STRIDES PHARMA INC
- Reason
- Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
- Published
- March 25, 2026
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass III
Winder Laboratories, LLC
- Product
- Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx…
- Reason
- Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.
- Published
- March 25, 2026
- Distribution
- Product was shipped to the following sta…
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FDA Recall
Ongoing
2026 recordClass II
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
- Published
- March 18, 2026
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Ongoing
2026 recordClass I
Ambrosia Brands LLC
- Product
- Rosabella brand MORINGA; DIETARY SUPPLEMENT CAPSULES; 60 cap…
- Reason
- Product may be contaminated with Salmonella
- Published
- March 18, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing
2026 recordClass II
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.
by MYLAN PHARMACEUTICALS INC
- Reason
- Failed Dissolution Specifications
- Published
- March 11, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing
2026 recordClass I
Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0
by Mohamed Hagar
- Reason
- Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
by Radnostix
- Reason
- Presence of Particulate Matter: Due to production issues
- Published
- March 11, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing
2026 recordClass I
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
by ANTHONY TRINH, 123Herbals LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.
by HTO Nevada Inc. dba Kirkman
- Reason
- Stability Data Does Not Support Expiry Date.
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
by HTO Nevada Inc. dba Kirkman
- Reason
- Stability Data Does Not Support Expiry Date.
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
by HTO Nevada Inc. dba Kirkman
- Reason
- Stability Data Does Not Support Expiry Date.
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
by Rising Pharma Holding, Inc.
- Reason
- Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
- Published
- March 11, 2026
- Distribution
- Nationwide
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FDA Recall
Ongoing
2026 recordClass II
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.
by The Harvard Drug Group LLC
- Reason
- Defective container; inadequately sealed blister packaging.
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass III
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17
by Cipla USA, Inc.
- Reason
- Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass III
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17
by Cipla USA, Inc.
- Reason
- Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.
by Harbin Jixianglong Biotech Co., Ltd.
- Reason
- CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China
by Harbin Jixianglong Biotech Co., Ltd.
- Reason
- CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.
by ACME UNITED CORPORATION
- Reason
- CGMP Deviations
- Published
- March 11, 2026
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
2026 recordClass II
Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00
by ACME UNITED CORPORATION
- Reason
- CGMP Deviations
- Published
- March 11, 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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