Quick answers
- What is Lincomycin used for?
- The FDA-approved label (Lincocin, Pharmacia & Upjohn Company LLC, March 10, 2025) says: “LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lincomycin have a boxed warning?
- Yes. The FDA label for Lincocin has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Lincomycin?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated March 26, 2026). Ask your pharmacist about alternatives.
- Has Lincomycin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Lincomycin?
- 9 companies list prescription products of Lincomycin in the FDA NDC Directory, including XGen Pharmaceuticals DJB, Inc., Armas Pharmaceuticals Inc. and Pharmacia & Upjohn Company LLC.
What Lincomycin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. …
— FDA label: Lincocin, Pharmacia & Upjohn Company LLC, effective March 10, 2025. Read the full label on DailyMed →
The FDA has 10 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.
This label has a boxed warning. Read it on the full label →
10 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intramuscular · Intravenous · Subconjunctival |
| Prescription products | 14 in the FDA NDC Directory |
| Brand names | Lincocin |
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.
- XGen Pharmaceuticals DJB, Inc.2 products
- Armas Pharmaceuticals Inc.2 products
- Pharmacia & Upjohn Company LLC2 products
- Gland Pharma Limited2 products
- Slate Run Pharmaceuticals, LLC2 products
- Micro Labs Limited1 product
- Sagent Pharmaceuticals1 product
- Henry Schein, Inc.1 product
- PAI Holdings, LLC dba PAI Pharma1 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 |
|---|---|---|---|
| NDA050317 LINCOCIN | Pfizer | December 29, 1964 | 160, latest April 11, 2022 2022: Labeling · 2018: Labeling · 2018: Labeling |
Generic approvals (5)
- ANDA201746Xgen Pharms · June 4, 2015
- ANDA212770Quagen · March 12, 2021
- ANDA215082Micro Labs · November 8, 2021
- ANDA215657Gland · September 26, 2022
- ANDA216662Hainan Poly · December 21, 2022
Shortage status
To be discontinued · updated March 26, 2026 · first posted March 26, 2026
| Product | Lincomycin Hydrochloride, Injection, 600 mg/2 mL vial x 10 count (NDC 39822-0350-2) |
|---|---|
| Company | XGen Pharmaceuticals DJB, Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 102787, 239212 |
|---|---|
| SPL set ID of the quoted label | c01906fa-2c73-4c13-9765-2fd06628d263 |
| FDA labels (SPL) | 10 |
| FDA applications | NDA050317, 5 ANDA |
| Active ingredients (FDA) | LINCOMYCIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lincocin, Pharmacia & Upjohn Company LLC, effective March 10, 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 →