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
1 hour 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-0434-2026
SODIUM CHLORIDE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.
Lots / Batch Codes & Expiration Dates
Batch# 24EU10010, Exp Date: 05/31/2027.
Distribution Scope
US Nationwide , Alaska, and Puerto Rico.
Class II (Moderate Risk)
Drug recall
Recall #: D-0445-2026
ISOTRETINOIN
Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Superpotent and Subpotent
Affected Product Description
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).
Lots / Batch Codes & Expiration Dates
Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027
Distribution Scope
FL, OH, PR & MS
Class II (Moderate Risk)
Drug recall
Recall #: D-0447-2026
OMNIPAQUE
Manufacturer / Recalling Firm: GE Healthcare Ireland Limited
Reason for Recall: Presence of particulate matter
Affected Product Description
GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1413-63.
Lots / Batch Codes & Expiration Dates
Lot# 17225029; Exp. September 3, 2028 Lot# 17265376; Exp. October 3, 2028 Lot# 17270885; Exp. September 10, 2028 Lot# 17292246; Exp. October 4, 2028 Lot# 17301805; Exp. October 18, 2028 Lot# 17301807; Exp. September 7, 2028 Lot# 17301810; Exp. October 20, 2028 Lot# 17304992; Exp. October 5, 2028 Lot# 17304993; Exp. October 19, 2028 Lot# 17304996; E...
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0442-2026
Vancomycin HCL
Manufacturer / Recalling Firm: Fagron Compounding Services
Reason for Recall: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Affected Product Description
Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01
Lots / Batch Codes & Expiration Dates
Lot: C274-000050987, Exp.:7/12/2026; C274-000049425, Exp.: 5/2/2026; C274-000050069, Exp.: 5/30/2026; C274-000050346, Exp.: 6/10/2026; C274-000050698, Exp.: 6/27/2026; C274-000050699, Exp.:6/27/2026; C274-000050775, Exp.:7/4/2026.
Distribution Scope
Nationwide in the U.S.A.
Class II (Moderate Risk)
Drug recall
Recall #: D-0446-2026
ISOTRETINOIN
Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Superpotent and Subpotent
Affected Product Description
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).
Lots / Batch Codes & Expiration Dates
Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
Distribution Scope
FL, OH, PR & MS
Class II (Moderate Risk)
Drug recall
Recall #: D-0431-2026
SODIUM CHLORIDE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.
Lots / Batch Codes & Expiration Dates
Batch# 6402290, 6402291, Exp Date: 01/31/2028; Batch# 6402411, Exp Date: 02/29/2028; Batch# 6402412, 6402419, 6402424, 6402425, 6402426, 6402427, Exp Date: 03/31/2028; Batch# 6402479, 6402480, 6402517, 6402571, Exp Date: 05/31/2028; Batch# 6402518, Exp Date: 06/30/2028.
Distribution Scope
US Nationwide , Alaska, and Puerto Rico.
Class II (Moderate Risk)
Drug recall
Recall #: D-0429-2026
SODIUM CHLORIDE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.
Lots / Batch Codes & Expiration Dates
Batch# 6402428, Exp Date: 10/31/2026; Batch# 6402481, 6402482, Exp Date: 11/30/2026.
Distribution Scope
US Nationwide , Alaska, and Puerto Rico.
Class II (Moderate Risk)
Drug recall
Recall #: D-0425-2026
SODIUM CHLORIDE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.
Lots / Batch Codes & Expiration Dates
Batch# 6402372, 6402374, Exp Date: 08/31/2026; Batch# 6402437, Exp Date: 10/31/2026.
Distribution Scope
US Nationwide , Alaska, and Puerto Rico.
Class II (Moderate Risk)
Drug recall
Recall #: D-0438-2026
norepinephrine Bitartrate
Manufacturer / Recalling Firm: Fagron Compounding Services
Reason for Recall: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Affected Product Description
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02
Lots / Batch Codes & Expiration Dates
Lot: C274-000049934, Exp.: 4/23/2026; C274-000049963, Exp.:4/24/2026; C274-000050074, Exp.: 4/30/2026; C274-000050123, Exp.:5/1/2026; C274-000050296, Exp.: 5/9/2026; C274-000050420, Exp.: 5/16/2026; C274-000050774, Exp.:6/5/2026; C274-000050924, 6/7/2026; C274-000050961, Exp.: 6/11/2026; C274-000050991, Exp.: 6/12/2026; C274-000051139, Exp.:6/19/20...
Distribution Scope
Nationwide in the U.S.A.
Class II (Moderate Risk)
Drug recall
Recall #: D-0443-2026
ARTIFICIAL TEARS
Manufacturer / Recalling Firm: Preferred Pharmaceuticals, Inc.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0
Lots / Batch Codes & Expiration Dates
Lot #: F1924R, F2024G, F2424E, G2424M, G2624P, J2424M
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0444-2026
XANAX
Manufacturer / Recalling Firm: Viatris, Inc.
Reason for Recall: Failed Dissolution Specifications
Affected Product Description
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91
Lots / Batch Codes & Expiration Dates
Lot# 8177156, Exp Date: 02/28/2027
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0433-2026
SODIUM CHLORIDE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.
Lots / Batch Codes & Expiration Dates
Batch# 23SU10001, Exp Date: 12/31/2026; Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027; Batch # 24EU10001, 24EU10002, Exp Date: 05/31/2027; Batch# 24PU10002, Exp Date: 11/30/2027; Batch# 25BU10003, Exp Date: 02/29/2028; Batch# 25EU10005, Exp Date: 05/31/2028.
Distribution Scope
US Nationwide , Alaska, and Puerto Rico.
Class II (Moderate Risk)
Drug recall
Recall #: D-0436-2026
DEXTROSE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.
Lots / Batch Codes & Expiration Dates
Batch# 6402399, 6402400, 6402401, Exp Date: 02/28/2027.
Distribution Scope
US Nationwide , Alaska, and Puerto Rico.
Class II (Moderate Risk)
Drug recall
Recall #: D-0437-2026
DEXTROSE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.
Lots / Batch Codes & Expiration Dates
Batch# 6402165, Exp Date: 05/30/2028.
Distribution Scope
US Nationwide , Alaska, and Puerto Rico.
Class II (Moderate Risk)
Drug recall
Recall #: D-0439-2026
norepinephrine Bitartrate
Manufacturer / Recalling Firm: Fagron Compounding Services
Reason for Recall: Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Affected Product Description
norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02
Lots / Batch Codes & Expiration Dates
Lot: C274-000050004, Exp.: 4/24/2026; C274-000050295, Exp.:5/8/2026; C274-000050773, Exp.: 6/4/2026; C274-000051219, Exp.: 6/21/2026; C274-000051318, Exp.: 6/27/2026; C274-000051602, Exp.: 7/12/2026.
Distribution Scope
Nationwide in the U.S.A.
Class II (Moderate Risk)
Drug recall
Recall #: D-0474-2026
CLONIDINE TRANSDERMAL SYSTEM
Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: CGMP Deviations: use of an unapproved raw material
Affected Product Description
Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by: Actavis Laboratories UT Inc., Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc, Parsippany, NJ, NDC 0591-3510-04 carton, NDC 0591-3510-54 pouch
Lots / Batch Codes & Expiration Dates
Lot: 100053892, Exp.: 04/2026; 100057899, Exp.: 05/2026; 100062704, Exp.: 02/2027.
Distribution Scope
Within U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0435-2026
DEXTROSE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.
Lots / Batch Codes & Expiration Dates
Batch# 6402296, Exp Date: 07/31/2026.
Distribution Scope
US Nationwide , Alaska, and Puerto Rico.
Class II (Moderate Risk)
Drug recall
Recall #: D-0423-2026
LANREOTIDE ACETATE
Manufacturer / Recalling Firm: Cipla USA, Inc.
Reason for Recall: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Affected Product Description
Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece. Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67
Lots / Batch Codes & Expiration Dates
Lot, expiry: 4401699IR1, Exp. 5/31/2026; 4401699IR2, Exp. 5/31/2026; 4401700IR1, Exp. 5/31/2026; 4401701IR1, Exp. 5/31/2026; 4401702IR1, Exp. 5/31/2026; 4401722IR1, Exp. 5/31/2026; 4401723IR1, Exp. 5/31/2026; 4401724IR1, Exp. 5/31/2026; 4401725IR1, Exp. 5/31/2026; 4401732IR1, Exp. 5/31/2026; 4401768IR1, Exp. 6/30/2026 4401769IR1, Exp. 1...
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0448-2026
OMNIPAQUE
Manufacturer / Recalling Firm: GE Healthcare Ireland Limited
Reason for Recall: Presence of particulate matter
Affected Product Description
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.
Lots / Batch Codes & Expiration Dates
Lot# 17333197; Exp. December 10, 2028 Lot# 17333198; Exp. November 17, 2028 Lot# 17396945; Exp. December 18, 2028 Lot# 17396948; Exp. December 22, 2028 Lot# 17396953; Exp. January 11, 2029 Lot# 17396956; Exp. January 9, 2029 Lot# 17423503; Exp. January 1, 2029 Lot# 17423525; Exp. January 3, 2029 Lot# 17426429; Exp. January 1, 2029 Lot# 17426440; Ex...
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0430-2026
SODIUM CHLORIDE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.
Lots / Batch Codes & Expiration Dates
Batch# 6402153, Exp Date: 11/30/2026; Batch# 6402297, 6402298, Exp Date: 01/31/2027; Batch# 6402377, 6402378, 6402379, Exp Date: 02/28/2027; Batch # 6402429, 6402430, 6402431, 6402432, 6402433, Exp Date: 03/31/2027; Batch# 6402434, Exp Date: 04/30/2027; Batch# 6402512, Exp Date: 05/2027; Batch# 6402574, 6402576, Exp Date: 06/30/2027.
Distribution Scope
US Nationwide , Alaska, and Puerto Rico.