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
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Lots, distribution and details
- Lots / codes
- Lot# 001, 002, 003, 004, 005, 006, 010, 011, 012, 013, 014, 016, 017, 018, 019, 020, Within Expiry.
- Distribution
- US Nationwide.
- Quantity
- 4374 tubes
- Recall started
- June 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0636-2026
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Class II Ongoing
Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4.
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Lots, distribution and details
- Lots / codes
- Lot# 007, 008, 009, 015, 016, Within Expiry.
- Distribution
- US Nationwide.
- Quantity
- 1087 tubes
- Recall started
- June 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0635-2026
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Class II Ongoing
Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Lots, distribution and details
- Lots / codes
- Lot# 0003, within expiry
- Distribution
- US Nationwide.
- Quantity
- 84 tubes
- Recall started
- June 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0634-2026
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Class II Ongoing
Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made i…
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Lots, distribution and details
- Product
- Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 10096 77162 9.
- Lots / codes
- Lot# 0004, within expiry
- Distribution
- US Nationwide.
- Quantity
- 84 tubes
- Recall started
- June 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0633-2026
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Class II Ongoing
Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 E…
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Lots, distribution and details
- Product
- Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 3 66715 97310 8.
- Lots / codes
- Lot# 0005, within expiry
- Distribution
- US Nationwide.
- Quantity
- 1225 tubes
- Recall started
- June 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0632-2026
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Class II Ongoing
Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300…
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Lots, distribution and details
- Product
- Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404, Made in India, UPC 1 94283 65181 0.
- Lots / codes
- Lot# 0001, and Lot# 0005, within expiry
- Distribution
- US Nationwide.
- Quantity
- 2420 tubes
- Recall started
- June 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0631-2026
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Class II Ongoing
Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plai…
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Lots, distribution and details
- Product
- Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10372 4.
- Lots / codes
- Lot# 0002, Lot# 0003, within expiry
- Distribution
- US Nationwide.
- Quantity
- 2503 tubes
- Recall started
- June 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0630-2026
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Class II Ongoing
Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461…
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Lots, distribution and details
- Product
- Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5.
- Lots / codes
- Lot# 0001, 0002, within expiry
- Distribution
- US Nationwide.
- Quantity
- 1102 tubes
- Recall started
- June 2, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0629-2026
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Class II Ongoing
Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) – 421506, INDIA. Distributed by: Risiong Pharma…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) – 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10
- Lots / codes
- [100 tablet bottle] Batch RISA24001; [1000 tablet bottle] Batch RISB24002; Exp. 04/2027
- Distribution
- U.S. Nationwide.
- Quantity
- 11,460 bottles
- Recall started
- June 5, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0610-2026
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Class III Ongoing
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date
Lots, distribution and details
- Product
- Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31
- Lots / codes
- Lot VA0099422; Exp. Date June 30, 2028
- Distribution
- U.S. Nationwide
- Quantity
- 7,803 bottles
- Recall started
- June 1, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0608-2026
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Class II Ongoing
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Product
- safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.
- Lots / codes
- BNZ-001921, Exp 04/15/2029
- Distribution
- Nationwide in the USA
- Quantity
- 150 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0606-2026
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Class II Ongoing
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Product
- PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30
- Lots / codes
- BNZ-001921, EXP 04/15/2029
- Distribution
- Nationwide in the USA
- Quantity
- 450 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0605-2026
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Class II Ongoing
Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Product
- Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30
- Lots / codes
- BNZ-001921, Exp 04/15/2029
- Distribution
- Nationwide in the USA
- Quantity
- 450 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0604-2026
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Class II Ongoing
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Lots / codes
- BNZ-001917, Exp 04/15/2029
- Distribution
- Nationwide in the USA
- Quantity
- 150 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0603-2026
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Class II Ongoing
DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Lots / codes
- BNZ-001921, EXP 04/15/2029
- Distribution
- Nationwide in the USA
- Quantity
- 150 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0602-2026
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Class II Ongoing
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Lots / codes
- BNZ-001921, EXP 04/15/2029
- Distribution
- Nationwide in the USA
- Quantity
- 150 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0601-2026
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Class II Ongoing
Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3.
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Lots / codes
- BNZ-001917, Exp 04/01/2029
- Distribution
- Nationwide in the USA
- Quantity
- 900 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0600-2026
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Class II Ongoing
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05
Reason: Crystallization; identified as Buprenorphine free base
Lots, distribution and details
- Product
- Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05
- Lots / codes
- Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
- Distribution
- Nationwide in the USA.
- Quantity
- 46,334 units
- Recall started
- June 12, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0596-2026
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Class II Ongoing
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.
Reason: Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Lots, distribution and details
- Lots / codes
- Lot: PA00805, expires: 01/31/2029
- Distribution
- U.S. Nationwide
- Quantity
- 6,143 bottles
- Recall started
- May 27, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0594-2026
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Class II Ongoing
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1.
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- Lot#: 20260327VAS-3, BUD: 05/26/2026; 20260320VAS-3, BUD: 05/19/2026.
- Distribution
- U.S.A. Nationwide
- Quantity
- 287 units
- Recall started
- May 18, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0593-2026
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Class II Ongoing
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-08.
Reason: Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Lots, distribution and details
- Lots / codes
- Lot #: AH001, expires: 8/31/2026
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 15, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0592-2026
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Class II Ongoing
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04.
Reason: Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Lots, distribution and details
- Lots / codes
- Lot #: AE006, expires: 5/31/2026
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 15, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0591-2026
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Class II Ongoing
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08.
Reason: Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Lots, distribution and details
- Lots / codes
- Lot #: AE001, expires: 5/31/2026.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 15, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0590-2026
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Class II Ongoing
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04.
Reason: Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
Lots, distribution and details
- Lots / codes
- Lot #: AE001, expires: 5/31/2026.
- Distribution
- U.S.A. Nationwide
- Quantity
- —
- Recall started
- May 15, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0589-2026
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Class II Ongoing
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals…
Reason: Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Lots, distribution and details
- Product
- Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29
- Lots / codes
- Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
- Distribution
- USA Nationwide.
- Quantity
- —
- Recall started
- May 27, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0588-2026
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 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.