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.
11 recalls
-
Class II Ongoing
Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara – 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534,…
Reason: Failed Impurities/Degradation Specifications.
Lots, distribution and details
- Product
- Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara – 391510 India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1907-1.
- Lots / codes
- Lot #: LB00047A, LB00048A, Exp. Date 03/2028
- Distribution
- Nationwide within the United States
- Quantity
- 70776 vials
- Recall started
- October 1, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0039-2027
-
Class II Ongoing
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Lots, distribution and details
- Lots / codes
- Lot# 001, 002, 013, 016, 031, 032, 033, 045, 046, 047, Within Expiry.
- Distribution
- US Nationwide.
- Quantity
- 4,944 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-0640-2026
-
Class II Ongoing
Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061.
Reason: CGMP Deviations; deficiencies observed during FDA inspection
Lots, distribution and details
- Lots / codes
- Lot# 003, 004, 005, 006, 007, 008, 009, 010, 011, 012, 014, 015, 017, 018, 019, 020, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 034, 035, 036, 037, 038, 039, 041, 042, 043, 044, 048, 049, 050, 051, 052, 053, 054, 055, 056, 057, 058, 059, 060, 061, 062, 063, 064, Within Expiry.
- Distribution
- US Nationwide.
- Quantity
- 4,738 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-0639-2026
-
Class III Terminated
Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05
- Lots / codes
- Lot 4212D4; Exp. 07/31/2026
- Distribution
- U.S. Nationwide
- Quantity
- 299 bottles
- Recall started
- March 18, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0482-2026
-
Class III Terminated
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
- Lots / codes
- Lot 4212D2; Exp. 07/03/2026
- Distribution
- U.S. Nationwide
- Quantity
- 2895 bottles
- Recall started
- March 18, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0481-2026
-
Class III Terminated
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
Reason: Subpotent Drug
Lots, distribution and details
- Product
- Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13
- Lots / codes
- Lot 4155D2, 4155D3; Exp. 05/15/2026
- Distribution
- U.S. Nationwide
- Quantity
- 1060 bottles
- Recall started
- March 18, 2026 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0480-2026
-
Class II Terminated
Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, NDC 55758-420-02, UPC 8 10096 77158 2.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot SP26A, Exp: 09/30/2026
- Distribution
- DE and NC
- Quantity
- 10,000 Tubes
- Recall started
- April 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0428-2025
-
Class III Completed
Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC…
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Lots, distribution and details
- Product
- Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01
- Lots / codes
- Lot # AD12890, Exp 09/30/2024
- Distribution
- Product was distributed to one distributor
- Quantity
- 96 vials
- Recall started
- August 7, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0633-2024
-
Class III Terminated
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532.…
Reason: Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Lots, distribution and details
- Product
- Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1
- Lots / codes
- Lot# AC86809, AC86812, Exp Date: 01/31/2024
- Distribution
- Nationwide in the USA
- Quantity
- 11,196 bottles
- Recall started
- November 6, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0089-2024
-
Class II Ongoing
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. ALL NDCs
- Lots / codes
- All Lots
- Distribution
- Nationwide in the USA and Puerto Rico
- Quantity
- N/A
- Recall started
- April 26, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0810-2023
-
Class II Ongoing
FS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.
Lots, distribution and details
- Product
- FS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Lots / codes
- SKUs: 910321; 910167
- Distribution
- Nationwide within the United States
- Quantity
- Unknown
- Recall started
- June 23, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1384-2022
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 October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.