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
47 minutes 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-0098-2026
Taoscare Motion Sickness Patches 36-count box
Manufacturer / Recalling Firm: ibspot
Reason for Recall: Marketed Without an Approved NDA/ANDA
Affected Product Description
Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan sheng zhou kou shi huai yang xian gong ye yuan qu, X003SR097N
Lots / Batch Codes & Expiration Dates
none
Distribution Scope
WY and VA
Class III (Low Risk)
Drug recall
Recall #: D-0032-2026
CETIRIZINE HYDROCHLORIDE
Manufacturer / Recalling Firm: JB Chemicals and Pharmaceuticals Ltd
Reason for Recall: Tablet/Capsules Imprinted with Wrong ID
Affected Product Description
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10.
Lots / Batch Codes & Expiration Dates
Lot # PY925014A; Exp. 1/31/2028
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0031-2026
GABAPENTIN
Manufacturer / Recalling Firm: The Harvard Drug Group LLC
Reason for Recall: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Affected Product Description
Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag).
Lots / Batch Codes & Expiration Dates
Lot # M04989A [Bag], M04989 [Blister Pack], Exp Date: 02/2026; Lot # M05056A [Bag], M05056 [Blister Pack], Exp Date: 04/2026; Lot # M05150A [Bag], M05150 [Blister Pack], Exp Date: 07/2026; Lot # M05312A [Bag], M05312 [Blister Pack], and M05342A [Bag], M05342 [Blister Pack], Exp Date: 01/2027.
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0096-2026
NIACIN
Manufacturer / Recalling Firm: Lannett Company Inc.
Reason for Recall: Failed Dissolution Specifications
Affected Product Description
Niacin Extended-release Tablets, USP, 1,000 mg, Rx Only, 90 Tablets per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 62175-322-46
Lots / Batch Codes & Expiration Dates
Lot, expiry: 21264027A, Exp 10/30/2025; 22266446A, Exp 12/31/2025; 22266901A, Exp 02/28/2026; 22267553A, 22267554A, Exp 03/31/2026; 22267555A, Exp 02/28/2026; 22267992A, Exp 04/30/2026; 22267993A, 22267994A, Exp 05/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0037-2026
BUPROPION HYDROCHLORIDE
Manufacturer / Recalling Firm: Graviti Pharmaceuticals Private Limited
Reason for Recall: Failed Tablet/Capsule Specifications
Affected Product Description
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.
Lots / Batch Codes & Expiration Dates
Batch # BPB124341A, Exp date: 10/2026
Distribution Scope
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0022-2026
Aloe Up Sport Performance Sunscreen Lotion SPF 30
Manufacturer / Recalling Firm: SV Labs Prescott Corporation
Reason for Recall: cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
Affected Product Description
Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) per tube, Mfd. for: ALOE UP, 9700 W. 76th St., Ste 112, Eden Prairie, Minnesota 55344
Lots / Batch Codes & Expiration Dates
Lot#: 25196, Exp 2/16/2026
Distribution Scope
USA Nationwide
Class III (Low Risk)
Drug recall
Recall #: D-0026-2026
EVEROLIMUS
Manufacturer / Recalling Firm: Endo USA, Inc.
Reason for Recall: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Affected Product Description
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 49884-125-91
Lots / Batch Codes & Expiration Dates
Lot #: 550172301, Exp. Date January 2026
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0021-2026
VIORELE
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: Failed Impurities/Degradation Specifications
Affected Product Description
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29.
Lots / Batch Codes & Expiration Dates
Batch number 20230733, Exp Date: October 2025
Distribution Scope
US Nationwide.
Class III (Low Risk)
Drug recall
Recall #: D-0025-2026
FentaNYL Citrate PF
Manufacturer / Recalling Firm: STAQ Pharma, Inc.
Reason for Recall: Labeling: Incorrect or Missing Lot and/or Exp Date
Affected Product Description
FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0102-05.
Lots / Batch Codes & Expiration Dates
Lot: 25102464B, Expiry: 26NOV2025; 25102370A, Expiry: 20OCT2025; 25102369A, Expiry: 19OCT2025.
Distribution Scope
Nationwide in the U.S.
Class III (Low Risk)
Drug recall
Recall #: D-0023-2026
Hydromorphone HCL PF
Manufacturer / Recalling Firm: STAQ Pharma, Inc.
Reason for Recall: Labeling: Incorrect or Missing Lot and/or Exp Date
Affected Product Description
Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.
Lots / Batch Codes & Expiration Dates
Lot #: 25104595A, Expiry: 27DEC2025.
Distribution Scope
Nationwide in the U.S.
Class II (Moderate Risk)
Drug recall
Recall #: D-0018-2026
ATORVASTATIN CALCIUM
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Dissolution Specifications
Affected Product Description
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Lots / Batch Codes & Expiration Dates
Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0017-2026
ATORVASTATIN CALCIUM
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Dissolution Specifications
Affected Product Description
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Lots / Batch Codes & Expiration Dates
Lot#: 25141249, Exp. Feb. 2027 Lot#: 24144938, Exp. Nov. 2026 Lot#: 24144868, Exp. Nov. 2026 Lot#: 24144867, Exp. Nov. 2026 Lot#: 24144458, Exp. Sep. 2026 Lot#: 24143994, Exp. Sep. 2026 Lot#: 24142987, Exp. July 2026 Lot#: 24143316, Exp. July 2026
Distribution Scope
U.S. Nationwide
Class I (High Risk)
Drug recall
Recall #: D-0015-2026
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use
Manufacturer / Recalling Firm: IntegraDose Compounding Services LLC
Reason for Recall: Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.
Affected Product Description
Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only, IntegraDose Compounding Services LLC, 719 Kasota Ave Se, Minneapolis, MN 55414-2842 NDC 71139-0012-1
Lots / Batch Codes & Expiration Dates
Lot #: 20250620OXY-1, Expiration date 10/18/2025
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0028-2026
FASENRA
Manufacturer / Recalling Firm: ASTRAZENECA PHARMACEUTICALS
Reason for Recall: Lack of Assurance of Sterility:
Affected Product Description
Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30
Lots / Batch Codes & Expiration Dates
Lot YJ0152, Expiry: 01/31/2028.
Distribution Scope
Nationwide in the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0027-2026
SUCRALFATE
Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity ch...
Affected Product Description
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
Lots / Batch Codes & Expiration Dates
Lot #: 1017392, Exp. Date 01/31/2026; 1017415, Exp. Date 12/31/2025.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0019-2026
ATORVASTATIN CALCIUM
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Dissolution Specifications
Affected Product Description
Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
Lots / Batch Codes & Expiration Dates
Lot #: 25140150, Exp. Dec. 2026 Lot #: 25140173, Exp. Dec. 2026 Lot #: 25140172, Exp. Dec. 2026 Lot #: 24144720, Exp. Nov. 2026 Lot #: 24144798, Exp. Nov. 2026 Lot #: 24144692, Exp. Oct. 2026 Lot #: 24143755, Exp. Aug. 2026 Lot #: 24143913, Exp. Aug. 2026 Lot #: 24143754, Exp. Aug. 2026 Lot #: 24143047, Exp. June 2026 Lot #: 24142936, Exp. July...
Distribution Scope
U.S. Nationwide
Class III (Low Risk)
Drug recall
Recall #: D-0024-2026
Ketamine Hydrochloride
Manufacturer / Recalling Firm: STAQ Pharma, Inc.
Reason for Recall: Labeling: Incorrect or Missing Lot and/or Exp Date
Affected Product Description
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Lots / Batch Codes & Expiration Dates
Lot #: 25156673A, Expiry: 02FEB2026.
Distribution Scope
Nationwide in the U.S.
Class II (Moderate Risk)
Drug recall
Recall #: D-0016-2026
TAVABOROLE
Manufacturer / Recalling Firm: VIONA PHARMACEUTICALS INC
Reason for Recall: Discoloration
Affected Product Description
Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.
Lots / Batch Codes & Expiration Dates
Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0029-2026
CARBIDOPA, LEVODOPA AND ENTACAPONE
Manufacturer / Recalling Firm: Rising Pharma Holding, Inc.
Reason for Recall: Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Enta...
Affected Product Description
Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ, 08816, Manufactured by Suven Pharmaceuticals Limited, Pashamylaram, Telangana, 205307, India. NDC# 16571-691-01
Lots / Batch Codes & Expiration Dates
Lot # CS25070, exp. date 03/31/2027
Distribution Scope
Distributed Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0020-2026
ATORVASTATIN CALCIUM
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Dissolution Specifications
Affected Product Description
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
Lots / Batch Codes & Expiration Dates
Lot#: 25140249, Exp. Dec. 2026 Lot#: 25140247, Exp. Dec. 2026 Lot#: 24144999, Exp. Nov. 2026 Lot#: 24144942, Exp. Nov. 2026 Lot#: 24144845, Exp. Nov. 2026 Lot#: 24144713, Exp. Nov. 2026 Lot#: 24144652, Exp. Oct. 2026 Lot#: 24143898, Exp. Aug. 2026 Lot#: 24143412, Exp. Aug. 2026 Lot#: 24143582, Exp. Aug. 2026
Distribution Scope
U.S. Nationwide