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-0419-2025
La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment
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 Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 883140500759, 40 mL (1.35 fl. oz.) Tube per Carton, La Roche-Posay LLC, 10 Hudson Yards, New York, NY 10001, La Roche-Posay, France.
Lots / Batch Codes & Expiration Dates
a) Lot #s, Expiration dates: MYX30W 03/2025 MYX43W 04/2025 MYX41W 04/2025 MYX42W 04/2025 MYX40W 04/2025 MYX51W 05/2025 MYX50W 05/2025 MYX60W 05/2025 MYX71W 06/2025 MYX90W 08/2025 MYX91W 09/2025 MYX92W 08/2025 MYXO0W 09/2025 MYX93W 09/2025 MYXD1W 11/2025 MYXD2W 11/2025 MYXDOW 09/2025 MYXD4W 11/2025 MYXD3W 11/2025 MYY22W 02/2026 MYY21W 02/2026...
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0413-2025
TESTOSTERONE PELLET 200 mg
Manufacturer / Recalling Firm: BSO LLC
Reason for Recall: Presence of Particulate Matter: Glass particles were found in pellet vials.
Affected Product Description
TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0125-01
Lots / Batch Codes & Expiration Dates
Lot 20250207@1, exp 1/31/2026; Lot 20250228@1, exp 1/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0406-2025
CARBOXYMETHYLCELLULOSE SODIUM
Manufacturer / Recalling Firm: BRS Analytical Services, LLC
Reason for Recall: cGMP deviations and lack of assurance of sterility.
Affected Product Description
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-068-15.
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 103, exp 4/26/25; Lot 104, exp 5/03/25; Lot 108, exp 6/29/25; Lot 109, exp 7/18/25; Lot 110, exp 8/17/25; Lot 111, exp 8/22/25; Lot 112, exp 8/27/25; Lot 113, exp 9/18/25; Lot 125, exp 10/23/25; Lot 130, exp 11/09/25; Lot 131, exp 11/14/25; Lot 132, exp 11/27/25; Lot 133, exp 11/30/25; Lot 134, exp 12/05/25; Lot 135, exp 12/11/2...
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0414-2025
TESTOSTERONE PELLET 200 mg BLUNT
Manufacturer / Recalling Firm: BSO LLC
Reason for Recall: Presence of Particulate Matter: Glass particles were found in pellet vials.
Affected Product Description
TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0124-01
Lots / Batch Codes & Expiration Dates
Lot 20250217@7, exp 1/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0407-2025
LUBRICANT EYE DROPS SOLUTION
Manufacturer / Recalling Firm: BRS Analytical Services, LLC
Reason for Recall: cGMP deviations and lack of assurance of sterility.
Affected Product Description
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 117, exp 9/20/25; Lot 118, exp 9/25/25; Lot 119, exp 9/27/25; Lot 121, exp 10/05/25; Lot 161, exp 5/01/26; Lot 171, exp 6/18/26; Lot 172, exp 6/24/26; Lot 174, exp 7/01/26; Lot 175, exp 7/08/26; Lot 200, exp 11/05/26; Lot 201, exp 11/10/26; Lot 202, exp 11/13/26; Lot 203, exp 11/18/26; Lot 204, exp 11/21/26; Lot 205, exp 11/25/26;...
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0415-2025
TESTOSTERONE PELLET 200 mg
Manufacturer / Recalling Firm: BSO LLC
Reason for Recall: Presence of Particulate Matter: Glass particles were found in pellet vials.
Affected Product Description
TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0122-01
Lots / Batch Codes & Expiration Dates
Lot 20250205@6, exp 1/30/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0408-2025
POLYVINYL ALCOHOL
Manufacturer / Recalling Firm: BRS Analytical Services, LLC
Reason for Recall: cGMP deviations and lack of assurance of sterility.
Affected Product Description
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 120, exp 10/02/25; Lot 122, exp 10/09/25; Lot 123, exp 10/12/25; Lot 124, exp 10/16/25; Lot 138, exp 1/08/26; Lot 142, exp 1/29/26; Lot 143, exp 2/01/26; Lot 144, exp 2/07/26; Lot 145, exp 2/12/26; Lot 146, exp 2/15/26; Lot 147, exp 2/21/26; Lot 148, exp 2/27/26; Lot 149, exp 3/04/26; Lot 150, exp 3/11/26; Lot 158, exp 4/15/26; Lo...
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0409-2025
FentaNYL 500mcg
Manufacturer / Recalling Firm: Apollo Care, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25
Lots / Batch Codes & Expiration Dates
Lot AC-016878, exp date 6/16/2025
Distribution Scope
MO
Class II (Moderate Risk)
Drug recall
Recall #: D-0416-2025
TESTOSTERONE PELLET 200 mg BLUNT
Manufacturer / Recalling Firm: BSO LLC
Reason for Recall: Presence of Particulate Matter: Glass particles were found in pellet vials.
Affected Product Description
TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01
Lots / Batch Codes & Expiration Dates
Lot 20250129@1, exp 1/17/2026; Lot 20250218@4, exp 1/25/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0405-2025
Carboxymethylcellulose Sodium Ophthalmic Gel 1%
Manufacturer / Recalling Firm: BRS Analytical Services, LLC
Reason for Recall: cGMP deviations and lack of assurance of sterility.
Affected Product Description
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 114, exp 9/04/25; Lot 115, exp 9/06/25; Lot 116, exp 9/10/25; Lot 207, exp 12/05/26
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0412-2025
TESTOSTERONE PELLET 100 mg
Manufacturer / Recalling Firm: BSO LLC
Reason for Recall: Presence of Particulate Matter: Glass particles were found in pellet vials.
Affected Product Description
TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01
Lots / Batch Codes & Expiration Dates
Lot 20250102@6, exp 12/11/2025; Lot 20250130@4, exp 1/22/2026
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall
Recall #: D-0402-2025
ROPIVACAINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Amneal Pharmaceuticals, LLC
Reason for Recall: Presence of Particulate Matter
Affected Product Description
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)
Lots / Batch Codes & Expiration Dates
Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0403-2025
TIMOLOL MALEATE
Manufacturer / Recalling Firm: FDC Limited
Reason for Recall: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Affected Product Description
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.
Lots / Batch Codes & Expiration Dates
Lot #: 083I098, Exp. Date 08/31/2025
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0404-2025
ARTIFICIAL TEARS
Manufacturer / Recalling Firm: BRS Analytical Services, LLC
Reason for Recall: cGMP deviations and lack of assurance of sterility.
Affected Product Description
Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 126, exp 10/26/25; Lot 127, exp 10/30/25; Lot 128, exp 11/02/25; Lot 129, exp 11/06/25; Lot 162, exp 5/09/26; Lot 163, exp 5/14/26; Lot 164, exp 5/20/26; Lot 165, exp 5/23/26; Lot 166, exp 5/29/26; Lot 167, exp 6/03/26; Lot 168, exp 6/06/26; Lot 169, exp 6/10/26; Lot 170, exp 6/13/26; Lot 193, exp 10/07/26; Lot 194, exp 10/10/26;...
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0411-2025
Clindamycin HCl Capsule
Manufacturer / Recalling Firm: RemedyRePack Inc.
Reason for Recall: CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Affected Product Description
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
Lots / Batch Codes & Expiration Dates
Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026.
Distribution Scope
Within U.S - PA, VA, FL.
Class II (Moderate Risk)
Drug recall
Recall #: D-0410-2025
temper tamer
Manufacturer / Recalling Firm: Siddha Flower Essences, LLC.
Reason for Recall: CGMP Deviations
Affected Product Description
temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.
Lots / Batch Codes & Expiration Dates
Lot# S22-26424D; Exp 9/27/2027
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0394-2025
LEVOTHYROXINE SODIUM
Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent
Affected Product Description
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17
Lots / Batch Codes & Expiration Dates
Lot # D2300323, Exp Date: 01/2026
Distribution Scope
Nationwide US.
Class II (Moderate Risk)
Drug recall
Recall #: D-0400-2025
Medroxyprogesterone Acetate Injectable Suspension
Manufacturer / Recalling Firm: Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall: Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products...
Affected Product Description
Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01
Lots / Batch Codes & Expiration Dates
Lot #: 1MP24042, Exp 6/30/26
Distribution Scope
Distributed to Medical Facilities in MS and FL.
Class II (Moderate Risk)
Drug recall
Recall #: D-0395-2025
LEVOTHYROXINE SODIUM
Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent
Affected Product Description
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-448-17.
Lots / Batch Codes & Expiration Dates
Lot # D2400547, Exp Date: 02/2026
Distribution Scope
Nationwide US.
Class II (Moderate Risk)
Drug recall
Recall #: D-0391-2025
Clindamycin Hydrochloride Capsules
Manufacturer / Recalling Firm: Preferred Pharmaceuticals, Inc.
Reason for Recall: cGMP Deviations
Affected Product Description
Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, NDC 68788-8685-03.
Lots / Batch Codes & Expiration Dates
Lot #: L0224T, K1824M, K0124N, J1624V, J0824O, I2424E, I1024O, A0925F, L2324L, Exp: 7/31/2026.
Distribution Scope
Nationwide in the US