Phentermine Capsules 15mg (PD-Rx) – impurity specification (2015)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC Newtown, PA 18840.
Brand
PD-Rx Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
Lot #: a) H14C80, Exp 08/16, I14G36, Exp 09/16, b) H14A86, Exp 07/16, c) H14C83, Exp 08/16, K14A21, Exp 11/16, d) H14F25, Exp 08/16, e) L14C42, Exp 12/16.
Products Sold
Lot #: a) H14C80, Exp 08/16; I14G36, Exp 09/16; b) H14A86, Exp 07/16; c) H14C83, Exp 08/16, K14A21, Exp 11/16; d) H14F25, Exp 08/16; e) L14C42, Exp 12/16.
PD-Rx Pharmaceuticals, Inc. is recalling Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-co due to Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperatur. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026