FDA Recall
Ongoing
Historical recordClass III
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
by AvKARE
- Reason
- Failed Impurity/Degradation Specifications
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
by AvKARE
- Reason
- Failed Impurity/Degradation Specifications
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3631-98.
by Orient Pharma Co., Ltd. Yunlin Plant
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- July 9, 2025
- Distribution
- NJ
View recall →
FDA Recall
Ongoing
Historical recordClass III
Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiwan, NDC 0480-3632-98.
by Orient Pharma Co., Ltd. Yunlin Plant
- Reason
- Failed Impurities/Degradation Specifications.
- Published
- July 9, 2025
- Distribution
- NJ
View recall →
FDA Recall
Ongoing
Historical recordClass II
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100-count bottle, NDC 70010-780-01; b) 500-count bottle, NDC 70010-780-05; Rx only, Manufactured by: Granules India Limited, Hyderadab-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151,
by Granules Pharmaceuticals Inc.
- Reason
- Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
by The Harvard Drug Group LLC
- Reason
- Defective container; blister packaging inadequately sealed.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61
by The Harvard Drug Group LLC
- Reason
- Defective container; blister packaging inadequately sealed.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET 0.08 FL OZ (2.6 mL) TOTAL, 12 Single-Use Swabs per carton, Manufactured for Church & Dwight Co. Inc. Ewing. NJ 08328 USA. UPC CODE 3 10310 40000 2.
by Church & Dwight Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
by Church & Dwight Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc., Ewing NJ. UPC 7 32216 30120 5
by Church & Dwight Inc
- Reason
- Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative Free, 10mL Sterile Single-Dose Vial, Rx Only, Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0001-0.
by Tailstorm Health INC
- Reason
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRINE 1:100,000, For Infiltration & Nerve Block, Including Caudal & Epidural Use, 10 mL Sterile Single-Dose Vial, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0037-0.
by Tailstorm Health INC
- Reason
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow IV Use, 5mL Sterile Multi-Dose Vial, Rx Only, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene, Rd. Chandler, AZ 85226, NDC 81483-0007-2.
by Tailstorm Health INC
- Reason
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Slow IV Use, 5 mL Sterile Single-Dose Vial, Rx Only, For Office Use Only, Compounded Durg by: Medivant Healthcare, 158 S. Kyrene Rd. Chandler, AZ 85226, NDC 81483-0006-0.
by Tailstorm Health INC
- Reason
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0.5%, (5mg/mL), 10 mL Sterile Single-Dose Vial, Rx Only, For Nerve Block, Caudal & Epidural Anesthesia Only, Warning: Contains Sulfites, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S. Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0036-0.
by Tailstorm Health INC
- Reason
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single Dose Vial, Rx Only, For Infiltration & Nerve Block, Including Caudal & Epidural Use, Preservative-Free, For Office Use Only, Compounded Drug by: Medivant Healthcare, 158 S Kyrene Rd., Chandler, AZ, 85226, NDC 81483-0000-0.
by Tailstorm Health INC
- Reason
- Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Vita Warehouse Corp.
- Product
- 1. Welby Vitamin B12 Adult Gummies 140 Count 2. Berkely Jens…
- Reason
- Contains undeclared peanut
- Published
- July 9, 2025
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Peak Cocktails
- Product
- Peak Cocktails Blood Orange Spritz 8.4 fl oz aluminum cans s…
- Reason
- Overpressurization leading to exploding cans
- Published
- July 9, 2025
- Distribution
- Product was distributed to consumers in:…
View recall →
FDA Recall
Ongoing
Historical recordClass II
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01
by Advanced Pharmaceutical Technology, Inc.
- Reason
- Marketed Without an Approved NDA/ANDA
- Published
- July 2, 2025
- Distribution
- NY and NJ
View recall →
FDA Recall
Ongoing
Historical recordClass II
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3
by Apotex Corp.
- Reason
- Lack of Assurance of Sterility
- Published
- July 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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