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
9 hours ago
Total FDA Recalls
1,170
Active / Ongoing
1,133
Critical (Class I)
63
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 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
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