Clobetasol Propionate recalls: 7 FDA reports
Recalls involving Clobetasol Propionate. What was wrong with each batch, and how the FDA graded the risk.
7Reports
1Class I
0Ongoing
2023-02-01Most recent
1 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Balt
D-0174-2023 · Class III · reported 2023-02-01 · Terminated
- Why it was recalled
- Subpotent Drug: Low assay result observed during long-term stability testing.
- Product
- Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03
- Where it went
- USA Nationwide
- How much
- 5720 tubes
Class I
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., H
D-0375-2022 · Class I · reported 2022-01-19 · Terminated
- Why it was recalled
- Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
- Product
- Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3
- Where it went
- Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.
- How much
- 96 tubes
Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx on
D-0618-2020 · Class III · reported 2019-12-18 · Terminated
- Why it was recalled
- Defective delivery system; product is not foaming or is coming out as liquid.
- Product
- Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100 g pack (NDC 68462-608-94), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No.: B-25, MIDC, Shendra Aurangabad - 431210, Maharashtra, India Manufactured for: Glenmark Pharmaceuticas Inc. USA Mahwah, NJ 07430
- Where it went
- Nationwide
- How much
- a) 34521 bottles; b) 16930 bottles
Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (ND
D-0619-2020 · Class III · reported 2019-12-18 · Terminated
- Why it was recalled
- Defective delivery system; product is not foaming or is coming out as liquid.
- Product
- Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
- Where it went
- Nationwide
- How much
- a) 480 packs; b) 240 packs
Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, In
D-0492-2019 · Class III · reported 2019-02-20 · Terminated
- Why it was recalled
- Defective Container; complaints of leakage.
- Product
- Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86
- Where it went
- Product was distributed to 4 major distributors in IL, NY, AR, KY who may have further distribute the product throughout the United States.
- How much
- 53,358 bottles
Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa
D-0249-2018 · Class III · reported 2018-02-07 · Terminated
- Why it was recalled
- Failed Content Uniformity Specifications
- Product
- Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3
- Where it went
- Nationwide
- How much
- 27,792 tubes
G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 071
D-0945-2017 · Class III · reported 2017-07-12 · Terminated
- Why it was recalled
- Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
- Product
- G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080
- Where it went
- Nationwide
- How much
- 145284 tubes
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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