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.
5 recalls
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Class II Ongoing
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pha…
Reason: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Lots, distribution and details
- Product
- Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
- Lots / codes
- Lot #: GEH25023, Expires: 6/30/2027
- Distribution
- Nationwide in the USA
- Quantity
- 675 bottles
- Recall started
- April 23, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0520-2026
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Class II Ongoing
Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lots: GS035031, GS035199, 20 mg; 90 tablets, Exp.: 03/2022; Lots: GS036495, GS036904, Exp.: 05/2022; Lots: GS037401, Exp.: 09/2022; Lots: GS037986, GS038359, GS039560, Exp.: 11/2022; Lot: GS041110, Exp.: 12/2022. (NDC: 60429-186-90).
- Distribution
- Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
- Quantity
- 1,424 bottles
- Recall started
- March 16, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1180-2022
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Class II Ongoing
Enalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lots: GS027890, GS028177, GS028488, 10 mg; 90 tablets, Exp.: 04/2022; Lots: GS028847, GS028848, Exp.: 09/2022; GS029627, GS029862,GS030057, GS030481, GS030870, GS031060, GS031437, GS031438, GS033527, GS034231, Exp.: 10/2022; Lots: GS034810, Exp.: 01/2023; Lots: GS035240, GS035598, Exp.: 05/2023; Lots: GS036194, Exp.: 06/2023; Lots: GS036760, GS036981,GS037526, GS038177, GS038728, Exp.: 08/2023; Lots: GS038729, GS041108, Exp.: 09/2023; Lots: GS039412, GS039840, GS041109, Exp.: 12/2023; Lot: GS041655, Exp.: 01/2024; Lot: GS041656, Exp.: 05/2024. (NDC: 60429-185-90).
- Distribution
- Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
- Quantity
- 31,260 bottles
- Recall started
- March 16, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1179-2022
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Class II Ongoing
Enalapril Maleate Tablets, USP; 5 mg; 90 tablets, NDC 60429-184-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot: GS029041, GS029353, GS02986, 5 mg; 90 tablets, Exp.: 09/2022; Lot: GS030056, GS030869, GS033943, Exp.: 10/2022; Lots: GS034490, GS035197, Exp.:02/2023; Lots: GS035198, Exp.: 03/2023; Lots: GS035596, GS035947, GS036759, GS037400, Exp.: 06/2023; Lots: GS038089, GS038763, GS039559, GS040150, Exp.: 10/2023; Lots: GS040151, GS040708, GS041107, Exp.: 12/2023; Lot: GS041654, Exp.: 03/2024.
- Distribution
- Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
- Quantity
- 9,058
- Recall started
- March 16, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1178-2022
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Class II Ongoing
Enalapril Maleate Tablets, USP; 2.5 mg; 90 tablets, NDC 60429-183-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA, USA.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lots: GS028301, 2.5 mg; 90 tablets, Exp.: 06/2022; Lots: GS029973, GS029974, GS031436, GS031715, GS033191, GS033940, Exp. : 10/2022; Lot: GS034212, Exp.: 12/2022; Lot: GS035315, GS035945, GS036905, GS038038, GS039199, Exp.: 04/2023; Lot: GS039200, GS040149, Exp.: 11/2023. (NDC: 60429-183-90).
- Distribution
- Nationwide in the U.S: PA, MA, OH, TX, IL, ND, HI
- Quantity
- 1,471 bottles
- Recall started
- March 16, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1177-2022
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 November 1, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.