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
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Class II Ongoing
Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.
Reason: Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Lots, distribution and details
- Lots / codes
- Lot # GS062298, Exp Date: 09/30/ 2026.
- Distribution
- US Nationwide.
- Quantity
- 6791 30-count bottles
- Recall started
- August 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0847-2026
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Class II Ongoing
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
Reason: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Lots, distribution and details
- Lots / codes
- Lot #: 3225272, Exp. September 30, 2026
- Distribution
- Nationwide within the U.S
- Quantity
- 47,662 bottles
- Recall started
- August 17, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0839-2026
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Class II Ongoing
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Lots / codes
- Lot no's: GS059908, GS060228, GS060709, GS061233, GS061704, GS062158, GS062405, Exp.: 04/30/2026
- Distribution
- U.S. Nationwide
- Quantity
- 2,601 30-count bottles
- Recall started
- March 5, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0287-2025
-
Class II Ongoing
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93
Reason: Failed Dissolution Specifications – low dissolution results
Lots, distribution and details
- Lots / codes
- Lot # 3211073, 3211074, 3211075, Exp 4/30/2026
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- February 25, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0280-2025
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.