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.
3 Class I (most serious) drug recalls reported in the last 30 days.
3,250 recalls
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Class II Ongoing
Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 20…
Reason: Subpotent Drug: Product does not contain SPF that is declared on the label.
Lots, distribution and details
- Product
- Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Sunscreen SPF 30, packaged as a 53mL (1.8 fl oz.) bottle, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-01
- Lots / codes
- Lot #: 1732A, 1732B, 1742A, 1742B, 1742C, 1742D; Exp. 06/2024.
- Distribution
- Nationwide in the USA, Spain, Italy, UK, and France.
- Quantity
- 5046 units
- Recall started
- August 18, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1175-2023
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Class I Ongoing
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover…
Reason: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Lots, distribution and details
- Product
- SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.
- Lots / codes
- FX001691, Exp. 12/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 1272 bottles
- Recall started
- September 8, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-1174-2023
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Class II Ongoing
octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Each (2X 15 mL Bottles), Manufactured for Innovus Pharmaceuticals, Inc., Englewood, CO 80112, Made in Jordan, NDC:57483-610-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: YM308 EXP:10/24;
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 30,490 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1167-2023
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Class II Ongoing
TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-099-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot:DD001 EXP: 07/24;
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 8,819
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1166-2023
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Class II Ongoing
TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-014-13.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot:182002 EXP: 11/24; Lot:182003 EXP: 11/24; Lot:182004 EXP: 12/24; Lot:182005 EXP:02/25; Lot:182006 EXP:02/25; Lot:182007EXP:02/25; Lot:182008 EXP:02/25; Lot:182009 EXP:02/25; Lot:182010 EXP:03/25: Lot:182011 EXP:03/25;
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 180,315 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1165-2023
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Class II Ongoing
TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-095-19.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: IW001 EXP:07/24; Lot: IW002 EXP: 12/24
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 196,442 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1164-2023
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Class II Ongoing
TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-058-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: FQ001 EXP:07/24
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 8,868 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1163-2023
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Class II Ongoing
TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-094-19.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: FP001 EXP:07/24
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 8,873
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1162-2023
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Class II Ongoing
TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-013-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: IV001 EXP:06/25; Lot:IV002 EXP: 11/24; Lot:IV004 EXP:01/25
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 293,400 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1161-2023
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Class II Ongoing
MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: 184001 EXP: 11/24; 184002 EXP: 11/24; 184003 EXP: 11/24; Lot: 184004 EXP: 12/24; Lot: 184005 EXP: 12/24; Lot:184006 EXP:12/24;
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 282,564 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1160-2023
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Class II Ongoing
TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-098-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: DA001 EXP: 06/24; Lot: DA002 EXP: 11/24
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 18,171 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1159-2023
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Class II Ongoing
TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (4 grams), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-165-13.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: 180001 EXP: 01/25
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 16,500 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1158-2023
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Class II Ongoing
TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-417-19.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: FV005 EXP:03/25
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 8,000 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1157-2023
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Class II Ongoing
TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-096-19.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: FR001 EXP: 07/24; Lot: FR004 EXP: 04/25; Lot:FR005 EXP: 04/25; Lot:FR006 EXP: 04/25; Lot: FR007 Exp: 04/25
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 83,898 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1156-2023
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Class II Ongoing
TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC:17312-178-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: IX001 EXP: 07/24; Lot: IX002 EXP: 12/24
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 196,111 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1155-2023
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Class II Ongoing
TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-002-11.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: DC001 EXP: 06/24
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 5,509
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1154-2023
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Class II Ongoing
TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-097-19.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: FT001; EXP: 07/24
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 8,810 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1153-2023
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Class II Ongoing
TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-032-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-032-15.
- Lots / codes
- Lot: IY001; EXP 07/24
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 8,747
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1152-2023
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Class II Ongoing
TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-027-15.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot#:DB001 EXP: 06/24
- Distribution
- Product was distributed to two (2) direct accounts in RI and CO.
- Quantity
- 8,747 units
- Recall started
- September 1, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1151-2023
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Class I Ongoing
Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA. UPC 8 931028 556885
Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Lots, distribution and details
- Lots / codes
- All lots, Expires: 01/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 120 bottles
- Recall started
- August 3, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-1150-2023
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Class II Ongoing
All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
Reason: CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.
Lots, distribution and details
- Lots / codes
- Miscellaneous
- Distribution
- Separate Distribution List (salvage buyers) provided by Inmar and will be uploaded. Final customer distribution unknown.
- Quantity
- Unknown
- Recall started
- August 14, 2023 (N/A)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1104-2023
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Class III Ongoing
Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pha…
Reason: Subpotent: Out of Specification for Assay Test at the 3-month time point.
Lots, distribution and details
- Product
- Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
- Lots / codes
- Batch # 19224744
- Distribution
- nationwide in the U.S.
- Quantity
- 1,200 bottles
- Recall started
- August 14, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-1095-2023
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Class III Ongoing
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot #: AMR103, Exp: 10/2023; Lot#: AMR201, Exp: 06/2024
- Distribution
- Nationwide in the USA
- Quantity
- 82,400 bottles
- Recall started
- July 27, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-1086-2023
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Class II Ongoing
Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
- Lots / codes
- Lot #: AL-05222023@901, BUD 7/22/23; AL-06122023@908CS, BUD 8/11/23
- Distribution
- Nationwide
- Quantity
- 102 vials
- Recall started
- July 13, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0944-2023
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Class II Ongoing
Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Di…
Reason: Defective Delivery System
Lots, distribution and details
- Product
- Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12
- Lots / codes
- Lot #: 220151, 220152, 220153, Exp. Date 11/2024
- Distribution
- Nationwide within the United States
- Quantity
- 2844 units
- Recall started
- June 22, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0941-2023
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 4, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.