Class I · High risk
Prograf (tacrolimus)
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Tacrolimus Ointment
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective Container: Tube split from side seam
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
Affected NDCs
68462-0534-35
68462-0534-65
68462-0534-94
Compare with the code on your package — it is the most precise check available.
Drug: Tacrolimus Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tacrolimus NDC 68462-0534 |
1 mg/g | Ointment Topical |
Glenmark Pharmaceuticals Inc., USA | Rx |
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- NDC code
- 68462-534-35
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1304-2022 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Tacrolimus recalls
See all
Class I · High risk
Astagraf XL
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class II · Moderate risk
Tacrolimus Capsules
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Class II · Moderate risk
Tacrolimus Capsules
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Class II · Moderate risk
Tacrolimus 0.03% Oph Solution Tacrolimus 0.1%
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Other recalls by Glenmark Pharmaceuticals Inc., USA
All 2022 recalls
Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Class II · Moderate risk
Alyacen 7/7/7
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Class II · Moderate risk
Ondansetron Orally Disintegrating Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
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