CLASS IIDrug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Hydrocortisone Acetate Suppositories, 25 mg recalled by Torrent Pharma
Torrent Pharma is recalling Hydrocortisone Acetate Suppositories, 25 mg, distributed nationwide in the US. The recall was initiated on 21 May 2019 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codesLot #s: a) 17L010, Exp. 11/2019; 18D018, Exp. 04/2020; 18F022; 18F022A, Exp. 06/2020. b) 17L019; 17L026, Exp. 11/2019; 18B005, Exp. 02/2020; 18D006, 18D012; 18D022, Exp. 04/2020; 18K006, Exp. 10/2020.
Quantity recalled140,436 suppositories
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton, NDC: 59741-301-12, b) 24 Adult Suppositories per carton, NDC: 59741-301-24, Manufactured by Bio-Pharm Inc., Levittown PA 19057.
Where it was distributed
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Which lots are affected?
Lot #s: a) 17L010, Exp. 11/2019; 18D018, Exp. 04/2020; 18F022; 18F022A, Exp. 06/2020. b) 17L019; 17L026, Exp. 11/2019; 18B005, Exp. 02/2020; 18D006, 18D012; 18D022, Exp. 04/2020; 18K006, Exp. 10/2020.
Where was it sold?
Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.