Quick answers
- What is Tetracycline hydrochloride used for?
- The FDA-approved label (Tetracycline Hydrochloride, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., March 18, 2025) says: “To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tetracycline hydrochloride have a boxed warning?
- No. None of the 15 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tetracycline hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tetracycline hydrochloride been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 23, 2020 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Tetracycline hydrochloride?
- 9 companies list prescription products of Tetracycline hydrochloride in the FDA NDC Directory, including Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Amneal Pharmaceuticals NY LLC and Bryant Ranch Prepack.
What Tetracycline hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. …
— FDA label: Tetracycline Hydrochloride, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective March 18, 2025. Read the full label on DailyMed →
The FDA has 15 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.
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 15 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 23 in the FDA NDC Directory |
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 |
|---|---|---|
| tetracycline hydrochloride 250 mg capsule | Generic | $0.2667 per capsule |
| tetracycline hydrochloride 500 mg capsule | Generic | $0.6560 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.
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4 products
- Amneal Pharmaceuticals NY LLC4 products
- Bryant Ranch Prepack4 products
- Actavis Pharma, Inc.2 products
- Breckenridge Pharmaceutical, Inc.2 products
- Chartwell RX, LLC2 products
- Preferred Pharmaceuticals Inc.2 products
- Pharmaka Generics Inc.2 products
- Proficient Rx LP1 product
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 |
|---|---|---|---|
| NDA050278 ACHROMYCIN V | Avet | October 8, 1957 | 21, latest March 31, 2025 2025: Labeling · 2016: Manufacturing (CMC) · 2016: Manufacturing (CMC) |
Generic approvals (5)
- ANDA061147Strides Pharma Intl · February 10, 1971
- ANDA061837Watson Labs · December 24, 1974
- ANDA062752Chartwell Tetra · August 12, 1988
- ANDA210674Amneal Pharms Ny · September 18, 2018
- ANDA210662Breckenridge · November 7, 2018
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.
-
March 23, 2020 · Class I · Terminated · D-1255-2020
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01 — Avet Pharmaceuticals, Inc.
-
March 23, 2020 · Class I · Terminated · D-1254-2020
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01 — Avet 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
| RxCUI (RxNorm) | 198250, 198252, 313252, 313254 |
|---|---|
| SPL set ID of the quoted label | eaa5b1bd-0927-46e4-b941-32fcc492d258 |
| FDA labels (SPL) | 15 |
| FDA applications | NDA050278, 5 ANDA |
| Active ingredients (FDA) | TETRACYCLINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tetracycline Hydrochloride, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective March 18, 2025; 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 →