Quick answers
- What is Clomipramine hydrochloride used for?
- The FDA-approved label (Anafranil, SpecGx LLC, November 26, 2024) says: “Anafranil ™ (clomipramine hydrochloride) Capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Clomipramine hydrochloride have a boxed warning?
- Yes. The FDA label for Anafranil has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Clomipramine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Clomipramine hydrochloride been recalled?
- FDA enforcement reports list 6 recalls of products of this medicine; the newest started October 22, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Clomipramine hydrochloride?
- 17 companies list prescription products of Clomipramine hydrochloride in the FDA NDC Directory, including SpecGx LLC, Alembic Pharmaceuticals Inc. and Micro Labs Limited.
What Clomipramine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Anafranil ™ (clomipramine hydrochloride) Capsules USP is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. …
— FDA label: Anafranil, SpecGx LLC, effective November 26, 2024. Read the full label on DailyMed →
The FDA has 19 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.
This label has a boxed warning. Read it on the full label →
19 of 19 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 51 in the FDA NDC Directory |
| Brand names | Anafranil |
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 |
|---|---|---|
| clomipramine hydrochloride 25 mg capsule | Generic | $0.2031 per capsule |
| clomipramine hydrochloride 50 mg capsule | Generic | $0.2522 per capsule |
| clomipramine hydrochloride 75 mg capsule | Generic | $0.2701 per capsule |
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.
- SpecGx LLC6 products
- Alembic Pharmaceuticals Inc.3 products
- Micro Labs Limited3 products
- Alembic Pharmaceuticals Limited3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Leading Pharma, LLC3 products
- Rising Pharma Holdings, Inc.3 products
- NorthStar Rx LLC3 products
- Golden State Medical Supply, Inc.3 products
- Lifestar Pharma LLC3 products
- Proficient Rx LP3 products
- Ajanta Pharma USA Inc.3 products
- Aurobindo Pharma Limited3 products
- Lupin Pharmaceuticals, Inc.3 products
- Major Pharmaceuticals2 products
- American Health Packaging2 products
- Bryant Ranch Prepack2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019906 ANAFRANIL | Specgx LLC | December 29, 1989 | 35, latest May 10, 2019 2019: Labeling · 2018: Labeling · 2017: Labeling |
Generic approvals (10)
- ANDA074694Taro · December 31, 1996
- ANDA208961Zydus Pharms · December 27, 2017
- ANDA209294Lupin · November 21, 2018
- ANDA211767Mankind Pharma · April 8, 2019
- ANDA211364Leading · February 7, 2020
- ANDA213219Micro Labs · June 22, 2020
- ANDA212285Unique · August 7, 2020
- ANDA213897Ajanta Pharma Ltd · October 2, 2020
- ANDA211822Alembic · August 4, 2021
- ANDA216440Aurobindo Pharma · March 20, 2023
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.
-
October 22, 2025 · Class II · Ongoing · D-0152-2026
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufactured for: Northstar — Zydus Pharmaceuticals (USA) Inc
-
October 22, 2025 · Class II · Ongoing · D-0153-2026
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar — Zydus Pharmaceuticals (USA) Inc
-
October 22, 2025 · Class II · Ongoing · D-0154-2026
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, — Zydus Pharmaceuticals (USA) Inc
-
June 27, 2025 · Class II · Terminated · D-0537-2025
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01 — Lupin Pharmaceuticals Inc.
-
April 10, 2025 · Class II · Terminated · D-0377-2025
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 681 — Lupin Pharmaceuticals Inc.
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August 23, 2022 · Class III · Terminated · D-1546-2022
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
ClomiPRAMINE Hydrochloride Capsules, USP 25mg, 100-count bottles, Rx only, LEADING PHARMA, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-167-01 — Leading Pharma, LLC
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) — Anafranil, SpecGx LLC, effective November 26, 2024; 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 →