Quick answers
- What is Phentermine hydrochloride used for?
- The FDA-approved label (Lomaira, Calvin Scott & Co., Inc., May 21, 2026) says: “LOMAIRA™ tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity in patients with an initial body mass index greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Phentermine hydrochloride have a boxed warning?
- No. None of the 109 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Phentermine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Phentermine hydrochloride been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started May 9, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Phentermine hydrochloride?
- 22 companies list prescription products of Phentermine hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, PD-Rx Pharmaceuticals, Inc. and Calvin Scott & Co., Inc..
What Phentermine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LOMAIRA™ tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity in patients with an initial body mass index greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes …
— FDA label: Lomaira, Calvin Scott & Co., Inc., effective May 21, 2026. Read the full label on DailyMed →
The FDA has 109 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 109 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 123 in the FDA NDC Directory |
| Brand names | Lomaira |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| phentermine hydrochloride 15 mg capsule | Generic | $0.1034 per capsule |
| phentermine hydrochloride 30 mg capsule | Generic | $0.1293 per capsule |
| phentermine hydrochloride 37.5 mg capsule | Generic | $0.1052 per capsule |
| phentermine hydrochloride 37.5 mg tablet | Generic | $0.0738 per tablet |
| phentermine hydrochloride 8 mg tablet | Generic | $0.6276 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack38 products
- PD-Rx Pharmaceuticals, Inc.13 products
- Calvin Scott & Co., Inc.10 products
- A-S Medication Solutions8 products
- Proficient Rx LP7 products
- KVK-Tech, Inc.7 products
- NuCare Pharmaceuticals, Inc.6 products
- Martek Pharmacal Co.5 products
- Sunrise Pharmaceutical, Inc.4 products
- Precision Dose, Inc.3 products
- Aurolife Pharma, LLC3 products
- Preferred Pharmaceuticals Inc.3 products
- Direct_Rx3 products
- Asclemed USA, Inc.3 products
- Northwind Health Company, LLC2 products
- DirectRx2 products
- Solco Healthcare U.S., LLC1 product
- TAGI Pharma, Inc.1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Epic Pharma, LLC1 product
- Chartwell RX, LLC1 product
- Elite Laboratories, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (18)
- ANDA083923Chartwell Rx · July 1, 1976
- ANDA040190Elite Labs Inc · May 30, 1997
- ANDA040228Elite Labs Inc · June 19, 1997
- ANDA040377Prinston Inc · January 4, 2002
- ANDA040526Sun Pharm Industries · October 23, 2003
- ANDA040875Kvk Tech · March 21, 2008
- ANDA040876Kvk Tech · March 31, 2008
- ANDA040886Kvk Tech · March 31, 2008
- ANDA040887Kvk Tech · April 24, 2008
- ANDA200272Elite Labs · January 31, 2011
- ANDA202248Elite Labs · September 28, 2012
- ANDA203068Aurobindo Pharma Ltd · August 6, 2014
- ANDA205008Nuvo Pharm · September 25, 2014
- ANDA205017Nuvo Pharm · September 25, 2014
- ANDA205019Nuvo Pharm · December 5, 2014
- ANDA203495Avanthi Inc · September 12, 2016
- ANDA204318Aurolife Pharma LLC · November 9, 2016
- ANDA203436Kvk Tech Inc · March 17, 2017
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 9, 2025 · Class II · Ongoing · D-0446-2025
cGMP deviations
Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01. — KVK Tech, Inc.
-
March 18, 2020 · Class II · Terminated · D-1236-2020
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01 — Aurobindo Pharma USA Inc.
-
August 11, 2017 · Class III · Terminated · D-1118-2017
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-6 — PD-Rx Pharmaceuticals, Inc.
-
August 3, 2017 · Class III · Terminated · D-1083-2017
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940 — KVK-Tech, Inc.
-
July 21, 2015 · Class III · Terminated · D-0574-2016
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
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 — PD-Rx Pharmaceuticals, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lomaira, Calvin Scott & Co., Inc., effective May 21, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →