Use caution Drug recall · FDA · Published April 7, 2014

Piramal Recalls Sevoflurane Due to Failed pH Specs

Piramal Critical Care recalls 12,600 bottles of Sevoflurane USP because the product was too acidic. Check lot numbers S2611I28 through S2931K07.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1262-2014Drug Piramal Critical Care ›

Use caution until it’s fixed

Failed pH Specifications: product was too acidic.

Take action

Contact the company

Recalling firmPiramal Critical Care, Inc.3950 Schelden Cir · Bethlehem, PA 18017-8936

✎ GovInfoNow plain-language explainer

Piramal Critical Care is recalling Sevoflurane, USP (Inhalation Anesthetic) because the product failed pH specifications and was found to be too acidic. The recall affects 12,600 bottles distributed nationwide to wholesale distributors and retailers. No specific remedy or action steps are currently stated in the record. Read more at govinfonow.com/recall/46147-piramal-critical-care-inc-recalls-sevoflurane-usp-inhalation-anesthetic-rx.

Source Summary by GovInfoNow · govinfonow.com/recall/46147-piramal-critical-care-inc-recalls-sevoflurane-usp-inhalation-anesthetic-rx · Updated October 13, 2026 · FDA enforcement record: FDA #D-1262-2014

Cite this page

“Piramal Recalls Sevoflurane Due to Failed pH Specs.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/46147-piramal-critical-care-inc-recalls-sevoflurane-usp-inhalation-anesthetic-rx. Based on FDA recall #D-1262-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1262-2014%22&limit=1).

The FDA announced on April 7, 2014, that Piramal Critical Care, Inc. voluntarily recalled Sevoflurane, USP (Inhalation Anesthetic) due to failed pH specifications. The product was too acidic.

How to tell if you have it

Brand: Piramal Critical Care
Product: Sevoflurane Inhalation Anesthetic
NDC: 66794-015-25
Lot #: S2611I28 (exp 9/16), S2511I14 (exp 9/16), S2531I16 (exp 9/16), S2721J21 (exp 10/16), S2871K03 (exp 11/16), S2881K03 (exp 11/16), and S2931K07 (exp 11/16)
Quantity: 12,600 bottles

The hazard

The Sevoflurane, USP (Inhalation Anesthetic) in 250 mL Amber Bottles failed pH specifications because the product was too acidic.

Context

GovInfoNow's records show Piramal Critical Care, Inc. has two other recalls on record since July 8, 2019. Other recent recalls of similar products include Water-Jel Lidocaine Wound Gel Recall (April 7, 2026), Cipla Diclofenac Gel Recall (Dec. 22, 2025), and American Regent Selenious Acid Injection Recall (July 24, 2026).

How to tell if you have this one

Look for Sevoflurane, USP (Inhalation Anesthetic), Rx Only, in a 250 mL Amber Bottle manufactured by Piramal Critical Care. Check the NDC: 66794-015-25 and one of the following lot numbers with expiration dates: S2611I28 (exp 9/16), S2511I14 (exp 9/16), S2531I16 (exp 9/16), S2721J21 (exp 10/16), S2871K03 (exp 11/16), S2881K03 (exp 11/16), or S2931K07 (exp 11/16).

Brand
Piramal Critical Care
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Verify if your inventory contains any of the recalled lot numbers: S2611I28, S2511I14, S2531I16, S2721J21, S2871K03, S2881K03, or S2931K07.
Contact Manufacturer
Since no remedy is stated in the record, contact Piramal Critical Care directly for further instructions on how to handle these units.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “To wholesale distributors and retailers located 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 8 months after the firm started it.

Apr 7, 2014Firm started the recall
Apr 25, 2014FDA classified it Class II
May 7, 2014Published in FDA’s Enforcement Report
Dec 15, 2014FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/46147-piramal-critical-care-inc-recalls-sevoflurane-usp-inhalation-anesthetic-rx">Piramal Recalls Sevoflurane Due to Failed pH Specs (GovInfoNow)</a>

Where this comes from

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-1262-2014 (April 7, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1262-2014 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.