Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
3,228 recalls
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Class II Ongoing
Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot 240709, exp 7/31/2026
- Distribution
- OH
- Quantity
- 23 vials
- Recall started
- February 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0394-2026
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Class II Ongoing
Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot 240903, exp 9/30/2026
- Distribution
- OH
- Quantity
- 2 vials
- Recall started
- February 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0393-2026
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Class II Ongoing
Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot 241113, Exp Date 11/30/2026 & Lot 250103, Exp Date 1/31/2027
- Distribution
- OH
- Quantity
- 820 vials
- Recall started
- February 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0392-2026
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Class II Ongoing
Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 4…
Reason: Presence of Particulate Matter: Due to production issues
Lots, distribution and details
- Product
- Sodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
- Lots / codes
- Batch I012626R-01, Exp 02/09/2026
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- 16 units
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0389-2026
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Class I Ongoing
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
Reason: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Lots, distribution and details
- Lots / codes
- All lots within expiry
- Distribution
- USA nationwide
- Quantity
- N/A
- Recall started
- October 20, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0388-2026
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Class II Ongoing
MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.
Reason: Stability Data Does Not Support Expiry Date.
Lots, distribution and details
- Product
- MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.
- Lots / codes
- Lot #: 795CP-0005, Exp. Date 06/30/2026
- Distribution
- Nationwide within the U.S
- Quantity
- 243 bottles
- Recall started
- February 18, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0387-2026
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Class II Ongoing
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
Reason: Stability Data Does Not Support Expiry Date.
Lots, distribution and details
- Lots / codes
- Lot #: 807CP-0003, Exp. Date 07/31/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 178 bottles
- Recall started
- February 18, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0386-2026
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Class II Ongoing
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
Reason: Stability Data Does Not Support Expiry Date.
Lots, distribution and details
- Lots / codes
- Lot #: 839CP-0016, Exp. Date 03/31/2026; 839CP-0017, Exp. Date 06/30/2026; 839CP-0018, Exp. Date 08/31/2026; 839CP-0019, Exp. Date 10/31/2026; 839CP-0020, Exp. Date 03/31/2027; 839CP-0021, Exp. Date 07/31/2027; 839CP-0022, Exp.Date 11/30/2027; 839CP-0023, Exp. Date 02/29/2028; 839CP-0024, Exp. Date 07/31/2028.
- Distribution
- Nationwide within the U.S
- Quantity
- 27,380 bottles.
- Recall started
- February 18, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0385-2026
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Class II Ongoing
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
Reason: Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Lots, distribution and details
- Lots / codes
- Lot #: 1TM0524003A, Exp. Date 09/2026.
- Distribution
- Nationwide within the U.S
- Quantity
- 1200 bottles
- Recall started
- March 3, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0384-2026
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Class II Ongoing
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.
Reason: Defective container; inadequately sealed blister packaging.
Lots, distribution and details
- Lots / codes
- Lot # N02640, Exp Date: 08/2027
- Distribution
- Nationwide US.
- Quantity
- 8892 cartons
- Recall started
- February 17, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0383-2026
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Class III Ongoing
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 2…
Reason: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Lots, distribution and details
- Product
- Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17
- Lots / codes
- Lot #: 5GJ0223, Exp 04/30/2027
- Distribution
- U.S.A. Nationwide
- Quantity
- 164 cartons
- Recall started
- February 18, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0382-2026
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Class III Ongoing
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carto…
Reason: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Lots, distribution and details
- Product
- Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17
- Lots / codes
- Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
- Distribution
- U.S.A. Nationwide
- Quantity
- 271 cartons – Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
- Recall started
- February 18, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0381-2026
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Class II Ongoing
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer:…
Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Lots, distribution and details
- Product
- Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.
- Lots / codes
- Batch # CP-030-20250911, Mfg Date: Sep. 25th, 2025, Retest Date: Sep. 24th, 2027.
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- February 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0380-2026
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Class II Ongoing
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotec…
Reason: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Lots, distribution and details
- Product
- Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China
- Lots / codes
- Lot #: CP-030-20250711, Exp. Date Jul. 24th, 2027
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- February 13, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0379-2026
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Class II Ongoing
Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: MN15423 , MN16422, Exp. Date Apr 2027-Apr; MN26322, MN26322, Exp. Date Aug 2027; MN03423, MN03423, Exp. Date Jan 2028; MN09722, Exp. Date Mar 2027; MN31722, Exp. Date Oct 2027; MN15722, MN13722 Exp. Date Apr 2027; MN31722, Exp. Date Oct 2027; MN09722, Exp. Date Mar 2027.
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- January 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0378-2026
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Class II Ongoing
Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: MN12122, Exp. Date Apr 2027; MN27523, Exp. Date Aug 2028; MN30922, Exp. Date Oct 2027.
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- January 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0377-2026
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Class II Ongoing
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5×7, 1000 packets, 5×7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: 53518, 53519, Exp. Date Jun 2027.
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- January 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0376-2026
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Class II Ongoing
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5×7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: 52347-R, 52348-R, 52349-R, 52350, 52351-R, 52352, Exp. Date Mar 2027; 53518, Exp. Date Jun 2027.
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- January 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0375-2026
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Class II Ongoing
Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: MN15922, Exp. Date Apr 2027; MN18223, Exp. Date May 2028; MN10123, Exp. Date Mar 2028; MN27223, Exp. Date Aug 2028; MN01023, Exp. Date Dec 2027.
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- January 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0374-2026
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Class II Ongoing
Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: MN24922, Exp. Date Aug 2027; MN31122, Exp. Date Oct 2027.
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- January 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0373-2026
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Class II Ongoing
WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5×7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: MN27922, MN21722, MN21822, Exp. Date Jul 2027; MN27422, MN27522, Exp. Date Sep 2027; MN25422, Exp. Date Aug 2027; MN27922, MN27922, Exp. Date Sep 2027.
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- January 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0372-2026
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Class II Ongoing
Med-Nap Cleansing Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr., Stelton, CT 06484, NDC 0924-0243-01.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: 52347, 52348, 52349, 52350, 52351, Exp. Date Mar 2027.
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- January 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0371-2026
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Class II Ongoing
Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: MN15923, Exp. Date May 2028; MN25822, Exp. Date Aug 2027.
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- January 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0370-2026
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Class II Ongoing
Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: 52347-R, 52348-R, 52349-R, 52350-R, 52351-R, 52352-R, 53518, 53519, Exp. Date Mar 2027.
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- January 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0369-2026
-
Class II Ongoing
Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot #: MN16022, Exp. Date Aug 2027; MN33922, MN31222, Exp. Date Apr 2027; MN16522, Exp. Date Oct 2027; MN17022, Exp. Date Apr 2027; MN03323, Exp. Date Jan 2028; MN34622, Exp. Date Oct 2027.
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- January 20, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0368-2026
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 1, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.