Dexamethasone Sodium Phosphate Ophthalmic (Franck's Lab) – Sterility Concerns (2012)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LIDOCAINE 0.5%/3% INJECTABLE 30 MLS; DEXAMETHASONE ACETATE (LA) 8MG/ML INJECTABLE 100 ML; DEXAMETHASONE IONTOPHORESIS, STERILE, P.F. 4MG/ML SOLUTION 20 ML, 30 ML (35 DIFFERENT PRODUCTS) 40 ML DEXAMETHASONE SDPF (0.1ML SYRINGE, 31G, 5/16" ) 0.4MG/ML INJECTABLE 0.3 ML 0.5 ML DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 10MG/ML (1%) INJECTABLE 0.05 ML 1 ML 16 ML
Brand
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Rx #'s: 0406046 0397385 0366980 0395509 0387345 0387381 0387586 0387752 0391041 0391584 0394112 0394246 0395288 0397054 0397946 0399555 0400910 0401208 0403442 0404123 0408115 0388847 0388144 0388144 0395892 0389202 0373332 0378850 0388550 0392222 0373332 0378850 0388550 0373332 0373332 0378850 0358046 0376175 0392337 0375442 0392337 0377047 0381838 0388945 0407636 0371528 0375458 0375458 0400150 0368414 0366367 0389059 0392819 0407227 0368231 0390906 0405998 0364593 0409797 0364593
Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LIDOCAINE 0.5%/3% INJECT due to Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because . This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026