FDA Enforcement Database
Drug Safety & Recalls Center
Access structured drug recall and safety information sourced directly from the U.S. Food & Drug Administration (FDA) OpenFDA Enforcement API. Stay informed on active market withdrawals, manufacturing defect notices, and drug safety advisories.
Last Synchronized
2 weeks ago
Total FDA Recalls
999
Active / Ongoing
962
Critical (Class I)
45
Medical & Legal Disclaimer: The information on this page is compiled for informational and educational reference only and does not constitute medical advice or clinical diagnosis. Never discontinue, start, or substitute any medication without consulting your prescribing doctor or a licensed pharmacist. For urgent health concerns regarding a recalled product, contact your physician immediately or report adverse events to FDA MedWatch.
Latest Critical Safety Updates (Class I)
Recent FDA enforcement reports involving serious health risk classifications
Class I
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinib...
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Ste...
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides.
Class II (Moderate Risk)
Drug recall
Recall #: D-0514-2025
GreenScreen
Manufacturer / Recalling Firm: KABANA SKIN CARE
Reason for Recall: cGMP deviations
Affected Product Description
GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Original, SPF 32, Totally Green personal care, Zinc Oxide USP 25%, 3.4 FL OZ/115 G Tube, NDC: 73369-0001-1
Lots / Batch Codes & Expiration Dates
Lots: 405-002 and 405-003
Distribution Scope
NJ, FL, MI
Class II (Moderate Risk)
Drug recall
Recall #: D-0508-2025
GABAPENTIN
Manufacturer / Recalling Firm: The Harvard Drug Group LLC
Reason for Recall: Defective container; blister packaging inadequately sealed.
Affected Product Description
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
Lots / Batch Codes & Expiration Dates
Lot# M05205A and M05205B, Exp Date 10/2026.
Distribution Scope
Nationwide
Class I (High Risk)
Drug recall
Recall #: D-0505-2025
ZICAM NASAL ALLCLEAR
Manufacturer / Recalling Firm: Church & Dwight Inc
Reason for Recall: Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Affected Product Description
ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church & Dwight Co,. Inc.., Ewing NJ. UPC 7 32216 30165 6
Lots / Batch Codes & Expiration Dates
All Lots.
Distribution Scope
Nationwide in the USA.
Class III (Low Risk)
Drug recall
Recall #: D-0526-2025
PITAVASTATIN
Manufacturer / Recalling Firm: Orient Pharma Co., Ltd. Yunlin Plant
Reason for Recall: Failed Impurities/Degradation Specifications.
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
P061001, P061002, P061003, P061004, P061006 & P061007 Exp Date 07/2025; P061008, Exp Date 08/2025; P061009 & P061010 Exp Date 10/2025; P061011, P061012 & P061013 Exp Date 01/2026; P061016, P061017 & P061018, Exp Date 04/2026; P061019, Exp Date 05/2026; P061023, Exp Date 01/2027.
Distribution Scope
NJ
Class II (Moderate Risk)
Drug recall
Recall #: D-0503-2025
LIDOcaine HCL Sterile Injection
Manufacturer / Recalling Firm: Tailstorm Health INC
Reason for Recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot #: 2504003, Exp. 04/03/2027
Distribution Scope
Nationwide in the US
Class III (Low Risk)
Drug recall
Recall #: D-0529-2025
PITAVASTATIN
Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Failed Impurity/Degradation Specifications
Affected Product Description
Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 46211, exp 10/31/2025; Lot 47683, exp 05/31/2026; Lot 46944 , exp 01/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0510-2025
METOPROLOL SUCCINATE
Manufacturer / Recalling Firm: Granules Pharmaceuticals Inc.
Reason for Recall: Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Affected Product Description
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,
Lots / Batch Codes & Expiration Dates
Lot # a)1400008A, Exp Date: 12/31/2025; b) 1400008B, Exp Date: 12/31/2025
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0498-2025
LIDOcaine HCl Injection
Manufacturer / Recalling Firm: Tailstorm Health INC
Reason for Recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot #s: 2502004, Exp. 2/18/27; 2503003, Exp. 3/19/27
Distribution Scope
Nationwide in the US
Class I (High Risk)
Drug recall
Recall #: D-0504-2025
ZICAM COLD REMEDY MEDICATED NASAL SWABS
Manufacturer / Recalling Firm: Church & Dwight Inc
Reason for Recall: Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Affected Product Description
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
Lots / Batch Codes & Expiration Dates
All lots.
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0499-2025
BUPIVAcaine HCL Sterile injection
Manufacturer / Recalling Firm: Tailstorm Health INC
Reason for Recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot #s: 2502005, Exp. 2/20/26; 2502006, Exp 2/23/2026
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0507-2025
GABAPENTIN
Manufacturer / Recalling Firm: The Harvard Drug Group LLC
Reason for Recall: Defective container; blister packaging inadequately sealed.
Affected Product Description
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
Lots / Batch Codes & Expiration Dates
Lot# M05205, Exp Date 10/2026
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0501-2025
KETAmine Hydrochloride Injection
Manufacturer / Recalling Firm: Tailstorm Health INC
Reason for Recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot: 2502009, Exp. 3/2/2026
Distribution Scope
Nationwide in the US
Class I (High Risk)
Drug recall
Recall #: D-0570-2025
PENICILLIN G POTASSIUM
Manufacturer / Recalling Firm: Sandoz Inc
Reason for Recall: Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Affected Product Description
Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.
Lots / Batch Codes & Expiration Dates
Lot # PG4360, PG4362, Exp. 11/30/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0502-2025
LIDOcaine HCL Sterile Injection
Manufacturer / Recalling Firm: Tailstorm Health INC
Reason for Recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot #s: 2503004, Exp. 3/23/2026; 2503005, Exp. 3/25/2026
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0500-2025
KETAmine Hydrochloride Injection
Manufacturer / Recalling Firm: Tailstorm Health INC
Reason for Recall: Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
Lot #s: 2502008, Exp. 2/27/2027; 2503001, Exp. 3/4/2027.
Distribution Scope
Nationwide in the US
Class III (Low Risk)
Drug recall
Recall #: D-0527-2025
PITAVASTATIN
Manufacturer / Recalling Firm: Orient Pharma Co., Ltd. Yunlin Plant
Reason for Recall: Failed Impurities/Degradation Specifications.
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
P051001, P051002, & P051003, Exp Date 07/2025; P051005, Exp Date 10/2025; P051006, Exp Date 10/2025; P051007, Exp Date 01/2026; P051010, Exp Date 07/2026; P051011 & P051012, Exp Date 09/2026; P051013, P051014 and P051015, Exp Date 01/2027.
Distribution Scope
NJ
Class III (Low Risk)
Drug recall
Recall #: D-0528-2025
PITAVASTATIN
Manufacturer / Recalling Firm: AvKARE
Reason for Recall: Failed Impurity/Degradation Specifications
Affected Product Description
Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 46208, exp 10/31/2025; Lot 47738, exp 09/30/2026; Lot 46943, exp 05/31/2026;
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall
Recall #: D-0569-2025
CEFAZOLIN
Manufacturer / Recalling Firm: Sandoz Inc
Reason for Recall: Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
Affected Product Description
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
Lots / Batch Codes & Expiration Dates
Lot # PG4360, PG4362, Exp. 11/30/2027
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall
Recall #: D-0506-2025
Orajel Baby
Manufacturer / Recalling Firm: Church & Dwight Inc
Reason for Recall: Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
Affected Product Description
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.
Lots / Batch Codes & Expiration Dates
All Lots.
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0491-2025
SODIUM CHLORIDE
Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Affected Product Description
0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Lots / Batch Codes & Expiration Dates
Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027
Distribution Scope
USA Nationwide