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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 hours ago
Total FDA Recalls
1,170
Active / Ongoing
1,133
Critical (Class I)
63
Data Provenance & Source Transparency: All drug recall records displayed are retrieved directly from the official U.S. FDA OpenFDA Enforcement API. Questo organizes and presents this data for medical education and research without modifying original regulatory facts. Explore OpenFDA API Documentation →
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
THYROID
Superpotent Drug
VITRUVIAS THERAPEUTICS INC Sep 23, 2026
Class I
NYSTATIN
Failed Stability Specifications
SUN PHARMACEUTICAL INDUSTRIES... Sep 23, 2026
Class I
SODIUM CHLORIDE
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic mat...
B BRAUN MEDICAL INC Sep 16, 2026
Showing 681–700 of 1,170 factual FDA recall reports
Class II (Moderate Risk)
Drug recall Recall #: D-0187-2026

Sea Enzyme Ultra Umbrella Sunscreen SPF 30

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4%, 4 oz./113.4 g per tube, Manufactured by CA BOTANA, San Diego, CA 92121. NDC: 35192-011-02
Lots / Batch Codes & Expiration Dates
Lot D53950, exp 5/31/2027
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0188-2026

Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Arnica, Menthol 5%, 4.2 oz./120 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-020-02
Lots / Batch Codes & Expiration Dates
Lot D53081, exp 7/31/2026
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0195-2026

CLEARSTEM YOU ARE SUNSHINE SPF 50

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Distributed by: CLEARSTEM Skincare, clearstemskincare.com. NDC: 35192-046-17
Lots / Batch Codes & Expiration Dates
Lot D54447, exp 11/30/2027
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0183-2026

Doctor. D. Schwab Mineral Sunscreen SPF 50

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02
Lots / Batch Codes & Expiration Dates
Lot Code D54596, exp 1/31/2028
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0189-2026

Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02
Lots / Batch Codes & Expiration Dates
Lot D54597, exp 1/31/2028
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0185-2026

Doctor D. Schwab Controlling Balm with Tea Tree Oil

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-016-05
Lots / Batch Codes & Expiration Dates
Lot Code D54361, exp 8/31/2027
Distribution Scope
CA, CO, FL, PR, WA
Class I (High Risk)
Drug recall Recall #: D-0182-2026

FAMOTIDINE

Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Lots / Batch Codes & Expiration Dates
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Distribution Scope
Nationwide within the United States as well as AK, HI, and PR.
Class II (Moderate Risk)
Drug recall Recall #: D-0186-2026

Doctor D. Schwab Controlling Cream

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92123. NDC: 35192-017-05
Lots / Batch Codes & Expiration Dates
Lot Code D54066, exp 5/31/2027
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0192-2026

Sugared+Bronzed Tinted Mineral Sunscreen SPF 50

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6
Lots / Batch Codes & Expiration Dates
Lot D53797, exp 04/30/27
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0194-2026

Elixir by Coco March Tinted Mineral Sunscreen SPF 50

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8
Lots / Batch Codes & Expiration Dates
Lot D53681, exp 03/31/2027
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0191-2026

Karina Daily Moisturizer SPF 25

Manufacturer / Recalling Firm: CA BOTANA International, Inc.
Reason for Recall: CGMP Deviations
FDA Report: Dec 03, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT. 5 oz/ 141.7 g per tube, Dist. By: Beauty4Pros LLC, Palm Desert, CA 92211. NDC: 35192-033-16, UPC 8 18204 02572 5
Lots / Batch Codes & Expiration Dates
Lot D54098, exp 3/31/2027
Distribution Scope
CA, CO, FL, PR, WA
Class II (Moderate Risk)
Drug recall Recall #: D-0161-2026

DermaCerin

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Lots / Batch Codes & Expiration Dates
All lots on or before expiry date 08/2027
Distribution Scope
Nationwide in the USA
Class III (Low Risk)
Drug recall Recall #: D-0156-2026

FESOTERODINE FUMARATE

Manufacturer / Recalling Firm: Alembic Pharmaceuticals Limited
Reason for Recall: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30
Lots / Batch Codes & Expiration Dates
Lot # 2405006633, Exp Date: 03/31/2026
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall Recall #: D-0160-2026

4-N-1 Skin Protectant

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
Lots / Batch Codes & Expiration Dates
All lots on or before expiry date 08/2027.
Distribution Scope
Nationwide in the USA
Class III (Low Risk)
Drug recall Recall #: D-0157-2026

Klarity-C Drops

Manufacturer / Recalling Firm: Imprimis NJOF, LLC
Reason for Recall: Subpotent Drug
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05
Lots / Batch Codes & Expiration Dates
Lot #:25JAN029, exp. date 07Nov2025; 25JAN042, exp. date 14Nov2025; 25JAN054, exp. date 21Nov2025; 25MAR021, exp. date 07Dec2025; 25APR017, exp. date 04Jan2026, 25APR025, exp. date 05Jan2026; 25MAY032, exp. date 31Jan2026; 25MAY055, exp. date 12Mar2026; 25MAY057, exp. date 14Mar2026; 25MAY073, exp. date 21Mar2026
Distribution Scope
USA nationwide
Class II (Moderate Risk)
Drug recall Recall #: D-0171-2026

SKIN PROTECTANT WITH LANOLIN

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
McKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgical Inc., Richmond, VA 23233.
Lots / Batch Codes & Expiration Dates
All lots on or before expiry date 08/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0159-2026

BROMOCRIPTINE MESYLATE

Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
Lots / Batch Codes & Expiration Dates
Lot #: M313934, M313935, M315615, Exp. Date Nov 2025; M316809 , Exp. Date Dec-25; M405765, M405763, M405764, Exp. Date Apr-26; M414999, M414241, M414307, M414305, Exp. Date Oct-26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0169-2026

Lantiseptic

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Lots / Batch Codes & Expiration Dates
All lots on or before expiry date 08/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0175-2026

Renew Skin Repair Cream

Manufacturer / Recalling Firm: DermaRite Industries, LLC
Reason for Recall: CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
Lots / Batch Codes & Expiration Dates
All lots on or before expiry date 08/2027
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall Recall #: D-0178-2026

Fentanyl citrate

Manufacturer / Recalling Firm: Park Avenue Compounding
Reason for Recall: CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
FDA Report: Nov 26, 2025 Status: Ongoing Voluntary: Firm initiated Source: FDA
View Full Report
Affected Product Description
Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110, NDC 83863-4272-1.
Lots / Batch Codes & Expiration Dates
Lot # 20250507-01D93C, Exp Date: 11-04-2025
Distribution Scope
Distributed in Missouri

FDA Recall Classes & Health Hazard Definitions

Official regulatory classifications defined by the U.S. Food & Drug Administration (21 CFR Part 7)

FDA Health Hazard Classifications
Class I — High Risk Severity

Class I Recall

Regulatory Definition: A situation in which there is a reasonable probability that exposure to a recalled product will cause serious adverse health consequences or death.

Examples: Microbial contamination of sterile injectables, presence of unlabelled severe allergens, toxic impurities, or dosage potency errors.
Class II — Moderate Risk Severity

Class II Recall

Regulatory Definition: A situation in which exposure to a recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse consequences is remote.

Examples: Sub-potent non-life-sustaining tablets, minor dissolution rate variations, or outer carton label misprints.
Class III — Low Risk Severity

Class III Recall

Regulatory Definition: A situation in which exposure to a recalled product is not likely to cause adverse health consequences, but violates FDA packaging or manufacturing regulations.

Examples: Minor packaging flaws, harmless tablet color variances, or minor typographical errors in package inserts.
Enforcement Action Statuses
Ongoing Action

Ongoing Status

The recall action is actively in progress across supply chains, distributors, healthcare facilities, and retail pharmacies nationwide.

Completed / Terminated

Completed & Terminated Status

The FDA has confirmed that all reasonable efforts have been made to remove or correct the product, and the enforcement file is officially closed.

System Notice

Confirm Action