Lower riskDrug recall · FDA · Published July 8, 2019
Piramal Critical Care recalls Gablofen injection due to unknown impurity risk
Piramal Critical Care recalls Gablofen (baclofen injection) 50 mcg/mL single-use syringes due to potential impurities observed during shelf life. Affected units include specific NDC and lot numbers.
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
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Contact the company
📍Recalling firmPiramal Critical Care, Inc.3950 Schelden Cir · Bethlehem, PA 18017-8936
“Piramal Critical Care recalls Gablofen injection due to unknown impurity risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38352-piramal-critical-care-recalls-gablofen-injection-due-to-unknown-impurity. Based on FDA recall #D-1742-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1742-2019%22&limit=1).
Piramal Critical Care, Inc. voluntarily recalled Gablofen (baclofen injection) on July 8, 2019, due to failed impurity specifications, according to the FDA. The Food and Drug Administration announced the Class II recall of single-use syringes distributed nationwide.
How to tell if you have it
Brand: Piramal Critical Care
Product: Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe
NDC: 66794-151-01
Lot codes: 2155-111, 2155-111A
Expiration date: 6/20
Quantity: Lot 2155-111 (1,418 boxes) and Lot 2155-111A (5,640 boxes)
The hazard
The recall addresses the presence of an unknown impurity observed during the shelf life of the product. Piramal initiated this precautionary measure because the product failed impurity specifications.
Context
GovInfoNow's records show Piramal Critical Care, Inc. has two other recalls on record since April 7, 2014. Other recent recalls of similar products include Lupin Ganirelix Acetate Injection Recall (Nov. 13, 2025), Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (Dec. 30, 2025), and Golden State Baclofen Tablets Recall (Nov. 26, 2025).
How to tell if you have this one
Check for the product name 'Gablofen (baclofen injection)', 50 mcg/mL, single-use syringe, packaged in a box with one 1 mL syringe. Look for NDC 66794-151-01 and lots 2155-111 or 2155-111A.
Brand
Piramal Critical Care
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the NDC number 66794-151-01 and lot numbers 2155-111 or 2155-111A on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2Published in FDA’s Enforcement Report
3FDA classified it Class II
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1742-2019 (July 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1742-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.