Prescription medicine
Lincomycin First approved as Lincocin
Lincomycin (Lincocin) is a prescription medicine with an FDA approval on record since 1964. FDA's NDC Directory lists it from 8 generic labelers.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the lincomycin FDA label on DailyMed (effective March 10, 2025, Pharmacia & Upjohn Company LLC); the NDA 50316 record on Drugs@FDA; every lincomycin label on DailyMed.
Highlights of the record
FDA label of March 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including LINCOCIN and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. Because lincomycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. […]
Used for
From the label: indications and usageLINCOCIN is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci.
Forms and strengths
- 300 mg/ml
- 600 mg/2ml
- 3000 mg/10ml
Injection (solution); injection.
On the market
- Earliest approval on file
- December 29, 1964 Lincocin, Pharmacia And Upjohn; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first April 16, 1991; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 8 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 3 past records
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 293 through July 30, 2026
What is lincomycin used for?
From the label: indications and usageLINCOCIN 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. Because of the risk of CDAD, as described in the BOXED WARNING , before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. LINCOCIN may be administered concomitantly with other antimicrobial agents when indicated. […]
Conditions named in the indications of lincomycin's FDA labels, with every medicine labeled for each:
From other lincomycin labelsBacterial infections: INDICATIONS AND USAGE LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci.
Source: FDA drug label (Lincocin), NDA050317 (Pfizer), as published by Pharmacia & Upjohn Company LLC, effective March 10, 2025 (SPL set c01906fa-2c73-4c13-9765-2fd06628d263), via openFDA; the full label on DailyMed
Is there a generic for lincomycin (Lincocin)?
The FDA approved the first generic lincomycin on April 16, 1991. 6 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists lincomycin from 8 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1964 earliest approval on file
- 1991 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is lincomycin in shortage?
No lincomycin presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 3 records are all marked to be discontinued, the latest updated March 26, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Lincocin, Injection, 2 mL multiple dose vial (NDC 0009-0104-04) | Pfizer Inc. | To Be Discontinued | February 25, 2026 |
| Lincomycin Hydrochloride, Injection, 3 grams/10 mL vial x 10 count (NDC 39822-0355-6) | XGen Pharmaceuticals DJB, Inc. | To Be Discontinued | March 26, 2026 |
| Lincomycin Hydrochloride, Injection, 600 mg/2 mL vial x 10 count (NDC 39822-0350-2) | XGen Pharmaceuticals DJB, Inc. | To Be Discontinued | March 26, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has lincomycin been recalled?
The FDA's Enforcement Report lists 1 recall naming lincomycin since 2013: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of lincomycin and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 28, 2013 | Class II | Main Street Family Pharmacy, LLC not a listed maker | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lincomycin label say about other medicines?
The lincomycin label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 10 other medicines name lincomycin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clindamycin | contraindications | CONTRAINDICATIONS LINCOCIN is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin. |
Other labels that name lincomycin
Source: FDA drug label (Lincocin), NDA050317 (Pfizer), as published by Pharmacia & Upjohn Company LLC, effective March 10, 2025 (SPL set c01906fa-2c73-4c13-9765-2fd06628d263), via openFDA; the full label on DailyMed
What do FAERS reports show for lincomycin?
The FDA Adverse Event Reporting System holds 293 reports that list lincomycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 28 are coded as a death and 99 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does lincomycin compare with medicines for the same use?
2 side-by-side pages set lincomycin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Lincomycin side effects
- the label's list beside FAERS reports
- Lincomycin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other