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.
29 recalls
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Class II Ongoing
Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3.
Reason: Defective Container; packets were found to be either empty or partially full.
Lots, distribution and details
- Lots / codes
- Lot # 245226005B, Exp Date: 04/30/2028.
- Distribution
- Nationwide in the USA.
- Quantity
- 2,592 30-count cartons
- Recall started
- September 8, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0873-2026
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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
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Class II Ongoing
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
Reason: Defective Container; packets were found to be either empty or partially full.
Lots, distribution and details
- Product
- Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
- Lots / codes
- Lot M251109, exp Nov 2027
- Distribution
- Nationwide in the USA
- Quantity
- 3964 Cartons
- Recall started
- May 12, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0543-2026
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Class II Ongoing
ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000125, Exp. 06/09/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 715 pellets
- 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-0315-2026
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Class II Ongoing
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000136, Exp. 07/01/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 2,442 pellets.
- 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-0314-2026
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Class II Ongoing
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000126, Exp. 06/09/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 133 pellets
- 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-0313-2026
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Class II Ongoing
ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000124, Exp. 06/02/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 1,475 pellets
- 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-0312-2026
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Class II Ongoing
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000123, Exp. 06/02/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 1,699 pellets
- 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-0311-2026
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Class II Ongoing
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000118, Exp. 02/21/2026; 253000145, Exp. 08/02/2026; 253000146, Exp. 06/30/2026, 253000167, Exp. 09/23/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 14,848 pellets
- 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-0310-2026
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Class II Ongoing
ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000117, Exp. 02/21/2026; 253000129, Exp. 06/12/2026; 253000130, Exp. 06/16/2026; 253000154, 253000155, Exp. 08/29/2026; 253000160, Exp. 09/10/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 22,478 pellets.
- 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-0309-2026
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Class II Ongoing
ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000132, Exp. 06/16/2026; 253000139, 253000140, Exp. 07/21/2026; 253000150, Exp. 08/08/2026; 253000151, Exp. 08/16/2026; 253000161, 253000162, Exp. 09/12/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 24,099 pellets
- 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-0308-2026
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Class II Ongoing
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000127, Exp. 06/09/2026; 253000133, Exp. 06/17/2026; 253000138, Exp. 07/14/2026; 253000141, Exp. 07/21/2026; 253000144, Exp. 07/28/2026; 253000147, Exp. 08/05/2026; 253000148, Exp. 08/07/2026; 253000149, Exp. 08/08/2026; 253000152, 253000153, Exp. 08/22/2026; 253000156, Exp. 09/03/2026; 253000157, Exp. 09/04/2026; 253000159, Exp. 09/05/2026; 253000164, Exp. 09/16/2026; 253000165, Exp. 09/19/2026; 253000170, Exp. 10/03/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 50,990 pellets
- 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-0307-2026
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Class II Ongoing
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 Lim…
Reason: Failed Impurities/Degradation Specifications
Lots, distribution and details
- Product
- 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 / codes
- Batch number 20230733, Exp Date: October 2025
- Distribution
- US Nationwide.
- Quantity
- 26,928 packs
- Recall started
- September 3, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0021-2026
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Class II Ongoing
Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3×28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC:…
Reason: Failed Content Uniformity Specifications
Lots, distribution and details
- Product
- Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3×28 tablets blister cards per carton, Rx only, Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84; Blister NDC: 42291-565-28
- Lots / codes
- Lot # LF41138A; Exp 06/30/2027
- Distribution
- U.S. Nationwide
- Quantity
- 2192 cartons
- Recall started
- September 2, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0007-2026
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Class II Completed
Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
Reason: Defective Container: Some packets may not be fully sealed, potentially allowing for loss of Ethanol from the product.
Lots, distribution and details
- Lots / codes
- Lot # 193109; Exp. 07/31/2026
- Distribution
- Nationwide in the USA
- Quantity
- 4944 cartons
- Recall started
- February 6, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0246-2025
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Class II Terminated
Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: 179338, Beyond use date: 08/14/2024
- Distribution
- Nationwide within the United States
- Quantity
- 2,797
- Recall started
- August 2, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0630-2024
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Class III Ongoing
Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-…
Reason: Failed Impurities/Degradation Specifications.
Lots, distribution and details
- Product
- Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1191-8
- Lots / codes
- Lot #: M311202, Exp. Date 2/25; M311201, Exp. Date 1/25
- Distribution
- Nationwide within the United States
- Quantity
- 13,440 units
- Recall started
- May 16, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0543-2024
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Class III Ongoing
Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192…
Reason: Failed Impurities/Degradation Specifications.
Lots, distribution and details
- Product
- Estradiol Transdermal System, USP (Twice-Weekly) 0.0375mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1192-8
- Lots / codes
- Lot #: M310493, Exp. Date 01/2025; M308397, Exp. Date 11/2024; M305337, Exp. Date 10/2024; M400155, Exp. Date 06/2025; M314660, Exp. Date 05/2025
- Distribution
- Nationwide within the United States
- Quantity
- 21,360 units
- Recall started
- May 16, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0542-2024
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Class II Terminated
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP – triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 009…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP – triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62
- Lots / codes
- Lot # 100039678, Exp 04/31/2024; 100038111, 100042277, Exp 07/31/2024
- Distribution
- USA nationwide.
- Quantity
- 92,676 cartons
- Recall started
- March 7, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0428-2024
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Class III Ongoing
Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North…
Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Lots, distribution and details
- Product
- Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58
- Lots / codes
- Lot #: 100040731, Exp 7/31/2024
- Distribution
- nationwide
- Quantity
- 19,824 cartons
- Recall started
- January 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0322-2024
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Class III Ongoing
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454,…
Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Lots, distribution and details
- Product
- Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
- Lots / codes
- Lot #: 100042978, Exp 7/31/2024
- Distribution
- nationwide
- Quantity
- 12,916 cartons
- Recall started
- January 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0321-2024
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Class II Terminated
Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots, distribution and details
- Product
- Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6
- Lots / codes
- Batch A5921
- Distribution
- Nationwide USA
- Quantity
- 1 unit
- Recall started
- January 26, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0187-2024
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Class II Terminated
ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02
Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Lots, distribution and details
- Product
- ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02
- Lots / codes
- Batch 100023687
- Distribution
- Nationwide USA
- Quantity
- 1 unit
- Recall started
- January 26, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0180-2024
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Class III Ongoing
Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan,…
Reason: Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Lots, distribution and details
- Product
- Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz (8.1 mL) per metered-dose pump, Rx Only, Manufactured by DPT Laboratories, Ltd San Antonio, TX 78215, Manufactured for: Perrigo, Allegan, Minnapolis, MN 55427, NDC: 0574-2067-27
- Lots / codes
- Lot# SCDR, Exp 02/2024
- Distribution
- Nationwide in the USA
- Quantity
- 43,238 cartons
- Recall started
- February 21, 2023 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0464-2023
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Class II Ongoing
Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch #: a) 01052210A1, Exp 4/5/2022; 10202101A1, Exp 4/18/2022; 01052210A1 7/4/2022; b)10202102A1, Exp 4/18/2022; 12022126A1, Exp 5/31/2022; 01052210A1, Exp 7/4/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 349 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1201-2022
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.