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.
4 recalls
-
Class II Ongoing
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lots, distribution and details
- Lots / codes
- Lot#: E409309, Exp 12/31/2026
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 600 30-count bottles
- Recall started
- September 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0002-2026
-
Class II Ongoing
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Lots, distribution and details
- Lots / codes
- Lot#: E409308, Exp 12/31/2026
- Distribution
- Distributed Nationwide in the USA
- Quantity
- 912 30-count bottles
- Recall started
- September 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0001-2026
-
Class II Ongoing
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Reason: Failed Impurity/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot E309377, Exp 11/30/2025
- Distribution
- U.S. Nationwide
- Quantity
- 4440 bottles
- Recall started
- September 4, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0657-2025
-
Class II Ongoing
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Reason: Failed Impurity/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot E309376; Exp 11/30/2025
- Distribution
- U.S. Nationwide
- Quantity
- 4344 bottles
- Recall started
- September 4, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0656-2025
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.