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.
2 recalls
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Class II Ongoing
Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
Reason: CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Lots, distribution and details
- Product
- Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes, Rx Only, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. 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-0821-2023
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Class II Ongoing
Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., B…
Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Lots, distribution and details
- Product
- Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66
- Lots / codes
- Lot: 16876, Exp.: 05/31/2023
- Distribution
- Nationwide in the United States including Guam and the Northern Mariana Islands.
- Quantity
- 1176 tubes
- Recall started
- April 21, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0849-2022
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.