CLASS III Drug recall · Reported 31 May 2017 · FDA Enforcement Report
Hydrocortisone Lotion recalled by Vintage Pharmaceuticals LLC
Vintage Pharmaceuticals LLC is recalling Hydrocortisone Lotion, USP, 2.5%, distributed nationwide in the US. The recall was initiated on 8 May 2017 and the FDA has classified it as Class III.
Check your package
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.
Recall details
- Recall number
- D-0859-2017
- FDA event ID
- 77210
- Recalling firm
- Vintage Pharmaceuticals LLC, Huntsville, AL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 8 May 2017
- FDA classified
- 23 May 2017
- Reported
- 31 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 8 May 2017 | Recall initiated by company | |
| 23 May 2017 | Classified by FDA | +15 days |
| 31 May 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent Drug: above specification for the assay.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-7785-52.
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
Superpotent Drug: above specification for the assay.
Which lots are affected?
Lot #: 0000004961, Exp. 05/17; 0000005197, 0000005198, 0000005199, Exp. 07/17; 0000005201, 0000005202, 0000005203, 0000005204, Exp. 09/17; 0000005200, 0000007998, 0000007999, 0000007022, Exp. 12/17; 0000009176, Exp. 04/18; 0000012281, 0000012282, Exp. 12/18
Where was it sold?
Nationwide in the USA and Puerto Rico.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Vintage Pharmaceuticals LLC
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Temazepam Capsules USP, 7.5 mg recalled by Vintage Pharmaceuticals LLC | Vintage Pharmaceuticals LLC | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrochlorothiazide Capsules, USP, 12.5 mg recalled | Vintage Pharmaceuticals LLC | Particulate Matter | Nationwide |
| Drug | CLASS III | Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL (75 mg recalled | Vintage Pharmaceuticals LLC | Potency & Assay | Nationwide |
| Drug | CLASS III | Ampicillin Capsules, USP, 250 mg recalled by Vintage Pharmaceuticals LLC | Vintage Pharmaceuticals LLC | Packaging Defects | OH |
Other Hydrocortisone recalls
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream recalledRapidol | Kenil Healthcare Private | Manufacturing (CGMP) Deviations | DE, NC |
| Drug | CLASS III | Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP dropper recalledHydrocortisone And Acetic Acid | Taro Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone and Acetic Acid Otic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone Ointment recalled by Mckesson Medical-SurgicalHydrocortisone | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hydrocortisone Acet 30mg recalled by Cardinal HealthHydrocortisone Acetate | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |