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-0436-2025
Nature Mint
Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-02
Lots / Batch Codes & Expiration Dates
Lot B0015, B0016, Exp Date: 05/31/2026; Lot B0020, B0021, B0022, Exp Date: 06/30/2026; Lot B0056, B0057, Exp Date: 07/31/2026; Lot B0108, B0109, B0110, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall
Recall #: D-0433-2025
Maximum Security
Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-01
Lots / Batch Codes & Expiration Dates
Lot B0010, B0017, Exp Date: 05/31/2026; Lot B0028, B0029, B0030, Exp Date: 06/30/2026; Lot B0052, Exp Date: 07/31/2026; Lot B0091, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall
Recall #: D-0442-2025
ESOMEPRAZOLE MAGNESIUM
Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Affected Product Description
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
Lots / Batch Codes & Expiration Dates
Lot # M311638, Exp 07/2025, M400374, Exp 10/2025, M402496, Exp 02/2026, M407998, Exp 05/2026, M502247, Exp 11/2026, M414770, M414512, Exp 09/2026.
Distribution Scope
Nationwide -in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0432-2025
Maximum Security
Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay-Varnia, NC 27526, NDC 53247-132-03
Lots / Batch Codes & Expiration Dates
Lot B0008, B0009, B0017, Exp Date: 05/31/2026; Lot B0042, B0043, B0044, Exp Date: 06/30/2026; Lot B0049, B0050, B0051, B0054, B0058, B0059, Exp Date: 07/31/2026; Lot B0061, B0062, B0063, B0064, B0065, B0068, B0069, Exp Date: 08/31/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall
Recall #: D-0445-2025
INDOMETHACIN
Manufacturer / Recalling Firm: KVK Tech, Inc.
Reason for Recall: cGMP deviations
Affected Product Description
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.
Lots / Batch Codes & Expiration Dates
Lot#: 18400A, Exp 7/31/2027
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0435-2025
Nature Mint
Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-06
Lots / Batch Codes & Expiration Dates
Lot B0027, B0031, Exp Date: 06/30/2026; Lot B0032, Exp Date: 07/31/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall
Recall #: D-0424-2025
Kingskin
Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 77163 6.
Lots / Batch Codes & Expiration Dates
Lot SP28A, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall
Recall #: D-0428-2025
RAPIDOL
Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, NDC 55758-420-02, UPC 8 10096 77158 2.
Lots / Batch Codes & Expiration Dates
Lot SP26A, Exp: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall
Recall #: D-0421-2025
ARTRIDON
Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New Castle, DE, 19720, Made in India, NDC 55758-030-05, UPC 8 10096 77151 3.
Lots / Batch Codes & Expiration Dates
Lot SP25A, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall
Recall #: D-0427-2025
Optim V
Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% - External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 6.
Lots / Batch Codes & Expiration Dates
Lot SP24A, Exp: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall
Recall #: D-0431-2025
Maximum Security Anticavity Gel Toothpaste
Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Maximum Security Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, Net Wt 0.6 OZ (17 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-02
Lots / Batch Codes & Expiration Dates
Lot B0009, B0017, Exp Date: 05/31/2026; Lot B0018, B0019, B0036, B0037, B0038, Exp Date: 06/30/2026; Lot B0049, Exp Date: 07/31/2026; B0063, Exp Date: 08/31/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall
Recall #: D-0443-2025
ESOMEPRAZOLE MAGNESIUM
Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Affected Product Description
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-848-94
Lots / Batch Codes & Expiration Dates
Lot #:M402147, Exp 10/2025; M311637, Exp 07/2025; M402495, Exp 02/2026; M407997, Exp 05/2026; M502246, Exp11/2026.
Distribution Scope
Nationwide -in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0434-2025
Maximum Security
Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 1.5 OZ (43 g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-132-04
Lots / Batch Codes & Expiration Dates
Lot B0013, Exp Date: 05/31/2026; Lot B0018, Exp Date: 06/30/2026; Lot B0053, B0054, Exp Date: 07/31/2026; Lot B0090, B0091, B0092, B0093, B0094, B0095, B0096, B0097, B0098, B0099, B0100, B0101, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall
Recall #: D-0440-2025
Nature Mint
Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 2.75 OZ (78g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-05
Lots / Batch Codes & Expiration Dates
Lot B0032, B0047, B0048, B0055, B0056, Exp Date: 07/31/2026; B0102, B0103, B0104, B0105, B0106, B0107, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall
Recall #: D-0439-2025
Nature Mint Anticavity Fluoride Toothpaste
Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 1.5 OZ (43 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-04
Lots / Batch Codes & Expiration Dates
Lot B0004, Exp Date: 05/31/2026; B0060, Exp Date: 07/31/2026; Lot B0067, B0071, B0072, Exp Date: 08/31/2026; Lot B0107, B0108, Exp Date: 09/30/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall
Recall #: D-0444-2025
AIRSUPRA
Manufacturer / Recalling Firm: AsttraZeneca Pharmaceuticals LP
Reason for Recall: Defective delivery system
Affected Product Description
Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, By: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France, Product of France, .
Lots / Batch Codes & Expiration Dates
Lot#: a) 6270044C00, 6270040D00, 6270034E00, Exp Date 10/2026; 6270053C00, 6270045C00, 6270047C00, 6270056C00, 6270052C00, 6270063E00 Exp 11/30/2026; 6270064C00, 6270071D00, 6270075D00, 6270075F00 Exp Date 12/31/2026; 6270107C00, Exp Date 9/30/2027; b) Lot 6270019E00, Exp Date 7/31/2025; 6270021D00, Exp 8/31/2025; 6270095C00, Exp 2/28/2026
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0438-2025
Nature Mint Anticavity Fluoride Toothpaste
Manufacturer / Recalling Firm: KENIL HEALTHCARE PRIVATE LIMITED
Reason for Recall: CGMP Deviations
Affected Product Description
Nature Mint Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina, NC 27526, NDC 53247-131-03
Lots / Batch Codes & Expiration Dates
Lot B0014, B0015, B0022, B0023, Exp Date: 05/31/2026; Lot B0024, B0025, B0026, B0027, B0033, B0034, B0035, B0039, B0040, B0041, B0045, Exp Date: 06/30/2026; Lot B0046, Exp Date: 07/31/2026
Distribution Scope
DE and NC
Class II (Moderate Risk)
Drug recall
Recall #: D-0420-2025
Testosterone Cypionate Injection
Manufacturer / Recalling Firm: Empower Clinic Services, LLC dba Empower Pharmacy
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364.
Lots / Batch Codes & Expiration Dates
Lot #: 202364, Exp 5/28/2025
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0417-2025
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment
Manufacturer / Recalling Firm: L'Oreal USA
Reason for Recall: Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Affected Product Description
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, Laboratoire Dermatologique, CAI 86270, La Roche-Posay, France, UPC 883140500759.
Lots / Batch Codes & Expiration Dates
Lot #: MYX46W, Exp 04/30/2025
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0418-2025
La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System
Manufacturer / Recalling Firm: L'Oreal USA
Reason for Recall: cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay E...
Affected Product Description
La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser 3.4 fl. oz. (100 mL) Tube, Clarifying Solution 3.4 fl. oz. (100 mL) Tube, Dual Action Acne Treatment 0.7 fl. oz. (20 mL: UPC 883140035275) Tube, (benzoyl peroxide 0.5% and benzoyl peroxide 5.5% and salicylic acid 2%), La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France, UPC 883140035282 (kit).
Lots / Batch Codes & Expiration Dates
Lot #s, Expiration Dates: MYX30W, Exp 03/31/2025 MYX32W, Exp 03/31/2025 MYX33W, Exp 03/31/2025 MYX41W, Exp 04/30/2025 MYX42W, Exp 04/30/2025 MYX43W, Exp 04/30/2025 MYX44W, Exp 04/30/2025 MYX45W, Exp 04/30/2025 MYX50W, Exp 05/31/2025 MYX51W, Exp 04/30/2025 MYX52W, Exp 04/30/2025 MYX53W, Exp 05/31/2025 MYX70W, Exp 07/31/2025 MYX80W, Exp 07/31/2025 MY...
Distribution Scope
Nationwide in the USA